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DISTRIBUTION AGREEMENT

Distribution Agreement

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This Distribution Agreement involves

TECHNISCAN, INC

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Title: DISTRIBUTION AGREEMENT
Governing Law: New York     Date: 10/16/2009

DISTRIBUTION AGREEMENT, Parties: techniscan  inc
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Exhibit 10.10

Execution Version

DISTRIBUTION AGREEMENT

This Distribution Agreement (“AGREEMENT”), made this 11th day of February 2008 by and between TECHNISCAN, INC., a Utah corporation (hereinafter referred to as “SELLER”) and ESAOTE S.p.A., a corporation organised and existing under the laws of the Republic of Italy with its principal office at Via Siffredi 58, Genova, 16153 Italy (hereinafter referred to as “DISTRIBUTOR”)

RECITALS

     WHEREAS, SELLER is engaged in the development 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 (the “Products”).

     WHEREAS, ESAOTE is a leading player in the market of ultrasound systems and has developed a proprietary technology for such systems.

     WHEREAS, on the date hereof SELLER and DISTRIBUTOR have entered into an original equipment manufacturing and development agreement (the “ OEM Agreement ”) for the further development of the Products that win provide for DISTRIBUTOR to provide certain required components to be included in and integrated with the Products.

     WHEREAS, SELLER expects that the Products shall be ready for sales by January 31, 2009.

     WHEREAS, SELLER shall manufacture the Products and sell them in the US market and other markets other than the Territory (as defined below).

     WHEREAS, SELLER wishes to appoint DISTRIBUTOR to exclusively distribute the Products in the Territory and DISTRIBUTOR is willing to accept such appointment, on the terms and conditions set forth herein.

     WHEREAS, at DISTRIBUTOR’S option, (i) SELLER will commit to negotiate in good faith an agreement to market, sell, and distribute certain products of DISTRIBUTOR into certain markets in the United States and (ii) SELLER will commit to negotiate in good faith an agreement to use ESAOTE’s existing distribution organization in the US as a regional distributor of the Company’s products into certain markets in the US.

     NOW THEREFORE, the Parties in consideration for the mutual premises contained herein hereby agree as follows:

 


 

ARTICLE 1

Definitions

     All capitalized terms will have the meanings ascribed to such terms in this Article 1 or as otherwise defined herein. Words importing the singular shall include the plural and vice versa.

     “ Adverse Event ” means any adverse health event to which a Product has or may have contributed. The term is generally limited to those events that would be reportable to a Regulatory Authority, e.g., Medical Device Reporting (MDR) to the FDA (U.S.) or Vigilance Reporting to Competent Authorities (EU).

     “ Agreement ” shall mean the present Distribution Agreement and all its Annexes.

     “ CE Mark ” shall mean the European Union CE Mark as described in EEC Medical Directive 93/42 of June 14, 1993.

     “ Bankruptcy ” or “ 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.

     “ Change of Control ” for the purposes of this section for SELLER 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 patent) 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 section for DISTRIBUTOR shall mean the above AND, in addition, that such a change results in a stop of DISTRIBUTOR 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 constitute a Change of Control of DISTRIBUTOR.). Notwithstanding the foregoing, a “ Change of Control ” does not include any Change of 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.

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      “Effective Date” shall mean the date when Product is ready for sale and the CE approval for sale of the Products in the Territory has been obtained.

     “ End User ” shall mean any customer of Products in the Territory.

     “ Field Action ” means any action by a Party that meets the criteria of a “recall,” “correction,” or “removal” as defined by applicable Regulatory Law.

     “ FDA ” shall mean the United States Food and Drug Administration or any successor agency having the authority to grant Marketing Approval in the United States.

     “ Marketing Approval ” means, with respect to any country or jurisdiction, the act of the applicable Regulatory Authority that is necessary under applicable Regulatory Laws for the manufacture, marketing and sale of a product in that country or jurisdiction, and satisfaction of all applicable regulatory and notification requirements and, to the extent applicable, the grant of Pricing Approval.

     “ Party ” means Each of ESAOTE S.p.A. and TECHNISCAN, INC.

     “ 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, including those listed in Annex A hereto. Without limitation, the term Products includes any new version of or replacements to the Products, and all updates, upgrades, and improvements thereof.

     “ Purchase Orders ” shall have the meaning set forth in Article 4.1 of the Agreement.

     “ Regulatory Authority ” means, with respect to any country or jurisdiction, any Governmental Authority involved in granting Marketing Approval or Pricing Approval or in administering Regulatory Laws in that country or jurisdiction, including the FDA in the United States.

     “ Regulatory Laws ” means all Applicable Laws governing (i) the import, export, design, testing, investigation, manufacture, sterilization, storage, distribution, marketing or sale of a product, (ii) establishing recordkeeping or reporting obligations for Third-Party Complaints or Adverse Events, (iii) Field Actions or (iv) similar regulatory matters.

     “ Sales Literature ” shall mean SELLER’s marketing and sales brochures, promotional materials, and other sales support publications pertaining to the Products.

     “ Specifications ” means the Technical and operational capabilities of the Products as provided in the Sales Literature, operating manuals or documentation for the Products.

     “ Term ” shall have the meaning set forth in Article 16.1 of the Agreement.

     “ Territory ” shall mean the territory of each of the countries of the European Union, Switzerland, Norway, Ukraine and the CIS (Russian Federation of related countries).

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ARTICLE 2

Scope of the Agreement

2.1 SELLER hereby grants DISTRIBUTOR an exclusive right and license to: (i) promote, market, sell and distribute the Products to End Users in the Territory during the Term directly and through its dealer and distribution channels; (ii) use the Products as reasonably required in connection with such marketing and distribution, including without limitation as necessary to provide service in connection with such Products; (iii) sublicense End Users to use the Products; (iv) translate, modify, and copy, in whole or in part, and distribute any of SELLER’s Sales Literarure or other marketing documentation pertaining to the Products at no additional charge and (v) such other rights and license as may be reasonably required in connection with the foregoing, including a license to SELLER’s patents, copyrights, trademarks, trade secrets and other intellectual property rights related to the Products, as specified in the OEM Agreement. SELLER shall not directly or indirectly sell or permit the promotion, marketing, sale or distribution of Products in the Territory except as provided in this Agreement.

2.2 DISTRIBUTOR shall undertake at its own expense to (a) use commercially reasonable efforts to promote the distribution of Products in the Territory and maintain an office and an adequate marketing organization for such activities; (b) maintain close liaison with the End Users and advise SELLER of any requirements expressed by End Users in a timely manner. DISTRIBUTOR shall have the right to affix DISTRIBUTOR’s own label or marking on the Products; provided such label is not larger than the label of SELLER and does not indicate DISTRIBUTOR as the manufacturer of the entire Product.

2.3 SELLER shall, where reasonably requested by DISTRIBUTOR, be available and provide at its own cost technical support to DISTRIBUTOR in its marketing and sales activities, road shows, exhibitions, press reporting and interviews. All other marketing activities expenses shall be borne by DISTRIBUTOR. SELLER shall perform at its own cost (for its employees and expenses) two initial instruction programs to DISTRIBUTOR’s sales organizations in the Territory.

2.4 If SELLER develops any new products during the Term of the Agreement, SELLER shall (i) provide DISTRIBUTOR with advance written notice of such new products; and (ii) offer Distributor a right to first negotiate to be the exclusive distributor of such new products in the Territory, before offering such new products for sale to any other customer or distributor in the Territory. If the Distributor elects to distribute such new products, it shall give Seller a written notice within fifteen (15) days from receipt of the notice of new products and the Parties agree to enter into negotiations of such distribution arrangements within the following thirty (30) days. If the Parties do not reach the Agreement within such term of thirty (30) days then SELLER, shall be tree to offer the right to distribute the new products to any third parties at no better terms and conditions than the terms offered to DISTRIBUTOR.

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ARTICLE 3

Order Placing

3.1 DISTRIBUTOR will submit purchase orders (“ Purchase Orders ”) for the Products and any requested spare parts for the Products to SELLER DISTRIBUTOR shall submit a Purchase Order in hard copy form or as an electronic message which complies with the requirements of the Agreement. The Purchase Orders shall include the following information: (a) Purchase Order number, (b) item part number, (c) item description, (d) quantity, (e) price, (f) delivery date requested, and (g) shipment destination.

3.2 Within ten (10) business days after receipt of a Purchase Order, SELLER shall acknowledge receipt of such Purchase Order and accept such Purchase Order by confirming in writing, by any means reasonably requested by DISTRIBUTOR, the delivery date, price and quantity for the ordered items. Amendments to Purchase Orders can be agreed in writing by the parties if received at least thirty (30) days before the estimated date of delivery. SELLER will use commercially reasonable efforts to fulfill the requirements of any Purchase Order.

3.3 Each shipment shall include a packing list that contains the Purchase Order number, product identification, proper shipping labeling and documentation, quantity shipped and date of shipment. The Products shall be delivered to the DISTRIBUTOR CIF to the destination defined by DISTRIBUTOR within the Territory. SELLER shall make shipments in the quantities specified in each DISTRIBUTOR Purchase Order. SELLER may make reasonable modifications to the Purchase Order due to circumstances beyond the SELLER’s reasonable control (for example, limited availability of third party components for the Products). DISTRIBUTOR shall have the right to terminate any modified Purchase Order. SELLER shall reimburse DISTRIBUTOR for the reasonable amount of any cost, expense, liability or cost which DISTRIBUTOR incurs by virtue of any rejection of a Purchase Order or the failure of SELLER to timely deliver Products under a Purchase Order for any reason.

3.4 DISTRIBUTOR and/or the End User shall have a reasonable right of inspection to verify that the Products conform to the product warranty in Article 8 and the applicable firm order. DISTRIBUTOR shall notify SELLER in writing of any defect or nonconformity as soon as practicable.

     DISTRIBUTOR may only reject a delivered Product that is defective or does not conform to Product specifications. If DISTRIBUTOR rejects any delivered Product, it shall return the defective or nonconforming Product to SELLER in accordance with the reasonable procedures set forth by SELLER. SELLER shall bear all costs of return (including freight and insurance) and shall either replace the defective or nonconforming Product without charge (including payment of freight and insurance for delivery of the replacement product) or, at DISTRIBUTOR’s request, refund to DISTRIBUTOR the entire amount paid (including tax, freight and insurance) in connection with the rejected Product.

     DISTRIBUTOR’s acceptance or deemed acceptance of any Product shall not be construed as a waiver of its warranty or indemnification rights hereunder.

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3.5 DISTRIBUTOR shall purchase from SELLER the minimum quantity of Products contemplated by the provisions of ANNEX B. The exclusive license provided hereunder shall convert to a non-exclusive license if DISTRIBUTOR is unable to realize sales equal to or greater than the minimum quantity set out in ANNEX B for two (2) consecutive years. If the license granted hereunder becomes non-exclusive, no other distributor shall be granted distribution rights that are more favorable than those provided to DISTRIBUTOR hereunder and no distribution rights shall be granted to a competitor of DISTRIBUTOR. For purposes of this Section 3.5, a “competitor of DISTRIBUTOR” shall mean a manufacturer of ultrasound equipment and its affiliated companies. DISTRIBUTOR shall not be responsible for any failure to achieve a sales level due to the failure of SELLER to deliver as requested any Products ordered under Article 3.

ARTICLE 4

Price List, Prices and Further Agreements Relating to the Products

PRICE LIST(s) is the Price List(s) (hereinbefore and hereinafter referred to as the “PRICE LIST”) received by The DISTRIBUTOR as evidenced into the “Price List Acknowledgement” Form signed by the DISTRIBUTOR for acceptance. This PRICE LIST is(are) an integral part of this appropriate AGREEMENT (see ANNEX C). The prices of the Products are CIF (INCOTERMS 2000) packaging (with appropriate air freight or sea shipping protection) included. All prices under the Agreement shall include applicable sales, use, value-added, withholding and any other taxes, tariffs and duties. The prices for Products shall be equal to 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). The Parties agree to evaluate the then-current Price List each year in connection with the establishment of the sales targets under Section 3.5. In connection, with such review, the Parties shall evaluate the market for the Products and the general market conditions thereof; provided, that the Parties presently expect that the trends over time are that prices will decline.

ARTICLE 5

Payment of Purchase Price

5.1 SELLER shall submit invoices to DISTRIBUTOR for each Product ordered and shipped in accordance with the terms and conditions of the Agreement Each invoice shall include the applicable Purchase Order number, identifying Product numbers, invoice quantity, unit price, and total invoice amount. Payments shall be made by the DISTRIBUTOR at SELLER’s domicile according to the agreed terms of payment, without any deduction for cash discount, expenses, taxes, levies, fees, duties, and the like.

5.2 In consideration for the rights and licenses granted herein, DISTRIBUTOR will pay SELLER for the Products in accordance with the amounts set forth in Annex C. All prices in the Agreement are quoted in Euros unless otherwise agreed in writing by the Parties. The payment of the purchase price of the Products shall be made in Euros within sixty (60) days after delivery to DISTRIBUTOR’s designated destination.

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5.3 The prices set forth on Annex C include a perpetual, paid-up, worldwide, irrevocable license for DISTRIBUTOR, and its End Users to use any related software/firmware (and updates thereto) which is furnished by SELLER in connection with the Products for the operation, maintenance, and repair of the Products.

5.4 Taxes . All prices under the Agreement shall include applicable sales, use, value-added, withholding and any other taxes, tariffs and duties.

ARTICLE 6

Undertakings by DISTRIBUTOR

6.1 Specific undertakings by DISTRIBUTOR

DISTRIBUTOR undertakes:

 

to use commercially reasonable efforts to market the Products in each country comprising the Territory.

 

 

to purchase from SELLER and to keep at all times a reasonable inventory of spare parts thereof in order to meet the recurring needs of the customers located in the Territory.

 

 

to deliver together with the Products one copy of the relevant official SELLER user manual, which represents the techn


 
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