Document:

Unassociated Document

 

Manufacturing Agreement

 

	
(1)

	
QualiMed Innovative Medizinprodukte GmbH

 

	
(2)

	
Inspire MD Ltd.

 

 

Dated September 11th                   2007

 

  

  

  

 

	
Contents

	  	  	  
	
1.

	
Definitions and interpretation

	
1

	
2.

	
Manufacture and supply of Products

	
2

	
3.

	
Price payment, taxes

	
3

	
4.

	
Delivery Risk and property in the Products

	
4

	
5.

	
Intellectual property rights of the Company

	
4

	
6.

	
Warranty

	
4

	
7.

	
Liability

	
5

	
8.

	
Confidential information

	
5

	
9.

	
Force majeure

	
5

	
10.

	
Term

	
6

	
11.

	
Termination

	
6

	
12.

	
General

	
6

	
13.

	
Governing law and jurisdiction

	
7

	
List of agreement Schedules

	
8

	  	  	  

 

  

2

  

 

This Agreement is made on the 11th day of September, 2007

 

Between:

 

	
(1)

	
QualiMed Innovative Medizinprodukte GmbH, Boschstr. 16, 21432 Winsen, Germany ("the Manufacturer"); and

	
(2)

	
Inspire MD Ltd., 4 Derech Hashalom St., Tel Aviv, Israel ("the Company").

 

Background:

 

The Company and the Manufacturer have agreed that the Manufacturer will manufacture the Product for the Company on the terms and conditions contained in this Agreement.

 

It is agreed as follows:

 

	
1.

	
Definitions and interpretation

 

	
1.1

	
In this Agreement, unless the context otherwise requires, the following words have the following meanings:

 

	 	
"this Agreement"

	
this Agreement (including any schedule or annexure to it and any document in agreed form);

	 	 	 
	 	
"the Intellectual

 Property"

	
as defined in clause 5;

	 	 	 
	 	
"the Know-How"

	
technical information, drawings, designs and other information relating to the Product and its manufacturing;

	 	 	 
	 	
"Materials"

	
any materials and components required for the manufacturing of the Product;

	 	 	 
	 	
"Order"

	
Purchase Order provided by the Company to the Manufacturer for a consignment of Products; Order shall specify quantity ordered, delivery address and terms, and delivery date;

	 	 	 
	 	
"the Patent Rights"

	
shall be All Patent applications filed by the Company to date.

	 	 	 
	 	
"the Price"

	
as defined in sub-clause 3.1;

	 	 	 
	 	
"the Product"

	
the product to be manufactured by the Manufacturer for the Company, details of which are set out in the Specification in schedule B to this Agreement ;

 

  

3

  

 

	 	
"the Specification"

	
the specification of the Product and its components set out in schedule B to this Agreement in accordance with which the Product is to be manufactured; and

	 	 	 
	 	
"the Term"

	
shall mean the duration of this Agreement under clause 11;

 

	
1.2

	
In this Agreement, unless the context otherwise requires:

 

	
  

	
(a)

	
words in the singular include the plural and vice versa and words in one gender include any other gender;

 

	
  

	
(b)

	
the table of contents and headings are for convenience only and shall not affect the interpretation of this Agreement; and

 

	
  

	
(c)

	
a reference to clauses and schedules are to clauses and schedules of this Agreement and references to sub-clauses and paragraphs are references to sub-clauses and paragraphs of the clause or schedule in which they appear.

 

	
2.

	
Manufacture and supply of Products

 

	
2.1

	
During the Term the Manufacturer shall promptly and diligently manufacture such numbers of the Products as the Company shall from time to time require in accordance with the Product Specifications and such Order as the Company shall serve on the Manufacturer. Purchase Orders may only be given in minimum quantities of 20 units per Product Type and size. The Company shall place these Orders in accordance with a monthly rolling, twelve month forecast of which the first two months should be binding and the third month should be binding with a tolerance of + / - 10 %. The first month has to be detailed in binding purchases Orders. All purchase orders delivered by the Company shall be acknowledged by Manufacturer in writing.

 

In accordance with the above, during the first and second months, the Manufacturer shall produce at least a “Minimum Quantity” of Products per each such months. Starting with 500 units per month, which shall be binding on the Company, the Minimum Quantity may be increased, based on binding notifications in advance as follows:

 

	
  

	
-

	
3 month in advance for up to 1000 units per month

 

	
  

	
-

	
6 month in advance for up to 2000 units per month

 

	
  

	
-

	
9 month in advance for up to 4000 units per month

 

  

4

  

 

A copy of the production file relevant to the production of the Product shall be provided to the Company at its first demand.

 

Manufacturer represents and warrants to the Company, that: (i) it does now, and shall at all times during the term it shall maintain at all times the required skill, personnel, equipment and facility required to fulfil its obligations under this Agreement; and (ii) that it is duly licensed to perform its obligations under this Agreement; (iii) to the best of its knowledge, fulfilling its obligations under this Agreement does not infringe on the intellectual property rights of a third party that is not a party to this Agreement;

 

	
2.2

	
The Manufacturer shall in addition to producing the Products to meet an Order manufacture for, and hold in stock, such quantities of components for Products as shall from time to time be agreed in writing between the Company and the Manufacturer.  The Manufacturer shall in addition hold in stock such other items as shall be agreed from time to time in writing between the Company and the Manufacturer. Initial quantities of components to be held in stock by Manufacturer are set forth in Schedule C to this Agreement.

 

Irrespective of the purchase Orders and forecast the Company is bound to purchase as much products as are required to clear the agreed minimum stock in case of termination of this agreement.

 

	
2.3

	
Upon receipt of Product(s) by the Company, Company shall perform acceptance tests to the Product and shall inform Manufacturer of any defects found and manufacturer shall then proceed with the immediate ratification of such defects pursuant to Section 6.2 below.

 

	
3.

	
Price, payment, taxes

 

	
3.1

	
The price of each complete unit of the Product shall be as defined in Schedule D to this Agreement.

 

The Price is valid "ex works". Price does not include any delivery expenses, such as freight, transfer, or insurance, which have to be paid by Company separately. The Company has to remove packing at his own expense.

 

	
3.2

	
The Company has to bear taxes and customs as well as to organise all formalities (for example customs declarations). Insurance will only be effected on the Company ́s explicit request and only, if Company defrays costs.

 

	
3.3

	
The Price is a net price and does not include German sales tax (Umsatzsteuer, VAT). German sales taxes, if any, shall be borne by the Company. With regard to deliveries within the European Union, Manufacturer will invoice German sales tax except for the case that the Company provides Manufacturer with the required proofs according to German sales tax law (Umsatzsteuerrecht) and that the German tax office confirms these proofs.

 

  

5

  

 

	
3.4

	
The Price is a net price also with respect to local withholding taxes in Israel. To the extent that the Company has to pay withholding taxes on the purchase price according to his national tax law, Company is obligated to provide Manufacturer with an attestation of the paid withholding taxes.

 

	
3.5

	
Deduction of cash discount must be agreed upon in writing.

 

	
3.6

	
The purchase price becomes due within 30 calendar days upon the date of receipt of defectless Products by the Company unless otherwise agreed. Upon expiry of this period without timely payment, the Company will be in delay with payment. If the Company is in delay with payment, Manufacturer is entitled to claim interest on arrears at the rate of LIBOR + 3% per annum.

 

	
3.7

	
Set-offs may only be declared in writing. The Company may only exercise a right of retention, if his counterclaim results from the same contractual relationship. The Company shall have no right of retention because of partial performances pursuant to § 320 para. 2 BGB.

 

	
4.

	
Delivery Risk and property in the Products

 

	
4.1

	
The delivery shall be on ex works basis.

 

	
4.2

	
The risk of loss to the Products shall pass to the Company upon despatch (ex works) unless otherwise agreed.

 

	
4.3

	
The Products remain the Property of the Manufacturer until full payment of the uncontested amounts by the Company.

 

	
5.

	
Intellectual property rights of the Company

 

	
5.1

	
The Manufacturer acknowledges the Company's right with regard to the Patent Rights, the Know-How, the Trade Name and any other intellectual property rights to the Products (including the Company's copyright in drawings, specifications, names and part numbers) ("the Intellectual Property") and the Manufacturer agrees that it will not either during the term of this Agreement or at any time thereafter (i) do or suffer to be done any act which may in any way infringe the Company's said rights or goodwill relating to the Products or the Company or its business.(ii) Directly or indirectly challenge the vailidity of the intellectual property of the Company;

 

  

6

  

 

5.2 The Manufacturer hereby warrants to the Company that to the best of its knowledge it has not and shall not provide the Company, under this Agreement, with any Product and or component that is designated to be part of the end product sold by the Company for which to the best of its knowledge may be infringing on the intellectual property rights of a third party. Should such alleged claim of infringement be brought against Manufacturer during the term of this Agreement, Manufacturer shall: 1) Immediately cease the production of such claimed against Product and or component, including its distribution or any other act that may be considered infringing by such third party; and 2) Immediately notify the Company of such alleged claim of infringement.

 

	
6.

	
Warranty

 

	
6.1

	
Manufacturer warrants that its Products will, under its intended use comply and function in accordance with their specifications and associated documentation in all material respects for a period of twelve (12)  form the date of delivery ("Warranty Period").

 

	
6.2

	
The Company will report any defects to Manufacturer in writing as soon as such information becomes known to the Company. Manufacturer will then examine and analyze the defects and use its best effort to provide a rectification within a reasonable period. Manufacturer shall fix all defects in the Product(s) in accordance with the Company’s request by either: i) exchanging the Product, ii) modifying or repairing the Product or work result, or iii) reperforming the manufacturing of the defective Product to achieve the agreed work result. Manufacturer may employ subcontractors to provide warranty services provided that use of subcontractors shall not relieve Manufacturer of any of its obligations under this Agreement. Should Manufacturer refuse or fail to provide such remedy within 60 days of notice from the Company the Company is entitled at its choice to terminate this Agreement and amend amount due to Manufacturer accordingly, deducting all damages suffered by the Company limited to the value of the defect Product.

 

	
6.3

	
Warranty claims are excluded in cases of insignificant deviations from the agreed quality such as non-reproducible errors and of natural wear and tear. They are also excluded if the Company used the Products or work results for other than the intended use, or in particular if they are modified without the prior written consent of Manufacturer.

 

	
7.

	
Liability

 

Claims of the Company to lost profits or consequential damages shall be excluded. The Manufacturer shall, at all times that it is supplying the Product commercially, maintain product liability insurance policies with insurers of recognized standing, with policy limits of not less than 5 million Euros per occurrence. The Company shall, at all times that it is selling or having sold the Product for commercial use, maintain product liability insurance policies with insurers of recognized standing, with policy limits of not less than 5 million Euros per occurrence. Each Party shall promptly notify the other Party in writing if such policies are to be revoked, canceled or materially decreased. Upon request, each party will provide the other party with a certificate of insurance from its insurers evidencing such insurance. Any further Liability of the Manufacturer is excluded, unless the Manufacturer (i) acted with wilful intend and/or gross negligence (ii) or wilfully concealed a default.

 

  

7

  

 

	
8.

	
Confidential information

 

The Parties agree both during the Term and thereafter that they shall cause their respective employees to sign all documents required to ensure that its employees and agents will not disclose or make any use whatsoever of all (i) Information exchanged between the parties and marked as confidential at time of disclosure; (ii) information pertaining to the Materials or the Products or the sale of them or (iii) the conduct of the Party's business, unless such information is:

 

	
  

	
(a)

	
lawfully and properly proved to be known to or in the possession of the Parties at the date of this Agreement; or

 

	
  

	
(b)

	
in the public domain at the date of this Agreement or which subsequently comes into the public domain through no fault of the other Party.

 

	
9.

	
Force majeure

 

	
9.1

	
The Manufacturer may totally or partially suspend manufacture of the Products and shall be under no liability whatsoever to the Company for any non-performance under this Agreement due to accidents, Acts of God, riots, civil commotions, fire, governmental action or any other circumstances beyond the control of the Manufacturer. It is however, agreed between the parties that should the Manufacturer fail to produce the Minimum Quantity or any quantity ordered by the Company during the Term for a period of more than 90 days, for whatever reason (the “Supply Short Fall), the Company shall have the right to terminate this Agreement and proceed with manufacturing of the Product using other entities. Company shall provide Manufacturer with a one month's written notice and upon expiry of such notice each party shall be released from all future obligations hereunder but such termination shall not relieve either party of any rights or from any obligations accruing before the occurrence of any such circumstances.

 

	
10.

	
Term

 

This Agreement shall commence on the execution of this Agreement and (subject to earlier termination as provided in this Agreement) shall continue for a period of 10 years, unless terminated pursuant to section 11 below.

 

  

8

  

 

	
11.

	
Termination

 

	
11.1

	
Termination for cause:

 

The Parties may by notice in writing to the other Party immediately terminate this Agreement if:

 

	
  

	
(a)

	
the other Party shall at any time be in breach of any of its obligations contained in this Agreement and such breach shall not be remedied within 30 days after notice from the Party of such breach;

 

	
  

	
(b)

	
the other Party shall go into liquidation other than for the purpose of reconstruction or amalgamation or be subject to an administration order or if a Receiver Administrator or Administrative Receiver be appointed in respect of the whole or any part of its assets or if the whole or any substantial part of its said assets be assigned for the benefit of its creditors;

 

	
  

	
(c)

	
In case of a supply shortfall, whereby Manufacturer has not delivered the Products to the Company for a period of over 60 days.

 

	
  

	
(d)

	
In case a any component provided by a party is claimed to be infringing on the intellectual property rights of a third party and such claim is supported by the written opinion of an independent patent attorney, then the non claimed-against party shall have the right to terminate this Agreement with a 30 days prior written notice.

 

	
  

	
(e)

	
In case the Development Agreement executed between the Parties on January 15th 2007 terminates, either party shall have the right to terminate this Agreement with a 30 days prior written notice.

 

	
12.

	
General

 

	
12.1

	
Entire agreement

 

This Agreement sets out the entire agreement and understanding between the parties in respect of the subject matter of this Agreement.

 

	
12.2

	
Invalidity

 

To the extent that any provision of this Agreement is found by any court or competent authority to be invalid, unlawful or unenforceable in any jurisdiction, that provision shall be deemed not to be a part of this Agreement, it shall not affect the enforceability of the remainder of this Agreement nor shall it affect the validity, lawfulness or enforceability of that provision in any other jurisdiction.

 

  

9

  

 

	
12.3

	
No partnership

 

Nothing in this Agreement shall be deemed to create a partnership between the parties.

 

	
12.4

	
Notices

 

Any notice to a party under this Agreement shall be in writing signed by or on behalf of the party giving it and shall, unless delivered to a party personally, be left at, or sent by prepaid first class post, prepaid recorded delivery, telex or facsimile to the address of the party as set out on page 1 of this Agreement or as otherwise notified in writing from time to time.

 

	
12.5

	
Variations

 

No purported variation of this Agreement shall be effective unless it is in writing and signed by or on behalf of each of the parties.  This applies also to this clause.

 

	
12.6

	
Assignment of rights

 

The Agreement or any right or obligation contained herein may be assigned to third parties only upon the prior written consent of the other party that shall not be unreasonably withheld. Notwithstanding the above, the Company shall have the right to assign its rights in: 1) case of an IPO, M&A or another form of change of control, provided that the assignee shall take all obligations incurred by the Company under this Agreement, or 2) to an affiliate company, or a company owned by the Company.

 

	
12.7

	
Releases and waivers

 

	
  

	
(a)

	
Any party may, in whole or in part, release, compound, compromise, waive or postpone, in its absolute discretion, any liability owed to it or right granted to it in this Agreement by any other party or parties without in any way prejudicing or affecting its rights in respect of that or any other liability or right not so released, compounded, compromised, waived or postponed.

 

	
  

	
(b)

	
No single or partial exercise, or failure or delay in exercising any right, power or remedy by any party shall constitute a waiver by that party of, or impair or preclude any further exercise of, that or any right, power or remedy arising under this Agreement or otherwise.

 

  

10

  

 

	
13.

	
Governing law and jurisdiction

 

	
13.1

	
This Agreement shall be governed by and construed in accordance with Swiss law excluding its conflict of law provisions and the UN Convention on Contracts for the International sales of Goods.

 

	
13.2

	
Each of the parties irrevocably submits for all purposes in connection with this Agreement to the exclusive jurisdiction of the courts of Switzerland.

 

	
13.3

	
All disputes arising out the performance of this agreement shall first be discussed and resolved between the parties. If such discussion do not yield positive results, the parties shall use an agreed upon mediator to solve the conflict. Mediation shall take place in the English language and be limited to a 3 hour international phone conference. Costs of mediation shall be equally borne between the parties hereto.

 

This Agreement has been signed on the date appearing at the head of page 1.

 

	
Wingen, 24/09/2007 (place and date)   

 

 

/s/ Manfred Guilder

	 	
Tel Aviv, Israel 11-9-07 (place and date)

 

 

/s/ Asher Holzer and /s/ Shmuel Behar

	
 

QualiMed Innovative Medizinprodukte GmbH

 

Represent by

 

Name: Manfred Guilder

 

Title:   Managing Director

 

 

List of Agreement Schedules:

 

Schedule A – Reserved

 

Schedule B – Product Specifications and Product Description

 

Schedule C – Initial Quantity for Production Stock

 

Schedule D – Prices and Delivery addresses and terms

	  	
 

Inspire MD Ltd.

 

Represent by

 

Name: Asher Holzer

 

Title:   President

 

 

Name: Shmuel Behar

 

Title: CFO

 

  

11

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

QualiMed Design Brief (DB)

of

MGuard Coronary Stent System (MGC-SIS)

Protective Mesh Covered Stent Implantation System

 

	
Project-No./

	
PTQ 060803-113

	
Projekt-Nr.

	  
	  	  
	
Contractor/

	
InspireMD

	
Vertragspartner

	
3 Menorat Hamaor st'

	  	
Tel Aviv 67448

	  	
Israel

	  	  
	
Coordination/

	
Manfred Gülcher

	
Koordinierung

	  
	  	  
	
Index of Design Brief/

	
01

	
Index des Design Briefs

	  

	
Release by person in charge (QualiMed)

	  
	
Freigabe durch Verfasser (QualiMed)

	
Date Signature

	  	  
	
Release by development director (QualiMed)

	  
	
Freigabe durch Entwicklungsleiter (QualiMed)

	
Date Signature

	  	  
	
Release by QA-Director (QualiMed)

	  
	
Freigabe durch QM-Leiter (QualiMed)

	
Date Signature

	  	  
	
Release by General Management (QualiMed)

	  
	
Freigabe durch Geschäftsführung (QualiMed)

	
Date Signature

	
Release by development director (Customer)

	  
	
Freigabe durch Entwicklungsleiter (Kunde)

	
Date Signature

	  	  
	
Release by QA-Director (Customer)

	  
	
Freigabe durch QM-Leiter (Kunde))

	
Date Signature

	  	  
	
Release by authorized person (Customer)

	  
	
Freigabe durch bevollmächtigte Person (Kunde)

	
Date Signature

 

Reproduction of this document in extracts subject to written approval of QualiMed and after consultation of the editor only.

 

	
QFB182

	
Datel:

QFB182 Design Brief

	
Freigogeben am:

20.04.2007

	
Ensteller:

BRR

	
Freigabe FB:

TNL

	
Freigabe QM

MGR

  

  

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

	
  

	
0

	
Table of Contents / Inhaltsverzeichnis

 

	
0

	
Table of Contents / Inhaltsverzeichnis

	
2

	
1

	
Protocol of Changes / Änderungshistorie

	
2

	
2

	
General / Allgemeines

	
3

	
2.1

	
Product

	
3

	
2.2

	
Platform

	
3

	
2.3

	
Supplier (Stent)

	
3

	
2.4

	
Sleeve

	
3

	
2.5

	
Supplier (Sleeve)

	
3

	
2.6

	
Catheter

	
3

	
2.7

	
Supplier  (catheter)

	
3

	
2.8

	
Contracts

	
3

	
2.9

	
Certificates

	
3

	
3

	
Specification – Requirements – Tolerances / Spezifikation – Anforderungen – Toleranzen

	
4

	
3.1

	
Bare Stent, small QM222

	
4

	
3.2

	
Technical Data, small – Stent, QM222

	
5

	
3.3

	
Bare Stent, medium QM214

	
6

	
3.4

	
Technical Data, Medium – Stent QM214

	
7

	
3.5

	
Sleeve

	
8

 

	
1

	
Protocol of Changes / Änderungshistorie

 

	
Index

	
Beschreibung

	
Date

	
Editor

	
00

	
First Version

	
07.09.2007

	
AHT

	
01

	
Second version; Chapter 3.2.3 Correction of a literal error (for the stent length 19/24/29/34/39 mm)

	
21.09.2007

	
AHT

	
Correction of RBP (Chapter 3.7.4)

	
28.09.2007

	
AHT

 

  

  

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

	
2

	
General / Allgemeines

 

	
Item

	
Specification

	
2.1       Product

	
Type:           MGC-SIS

MGuard Coronary Stent System

(Stainless Steel)

	
2.2       Platform

	
Type:           Double S (Stainless Steel Stent)

 

Design:                      Small:  QM222

Medium:  QM214

	
2.3       Supplier (Stent)

	
QualiMed Innovative Medizinprodukte GmbH

Boschstraße 16

D-21423 Winsen (Luhe)

Germany

Tel.-No.:  +49 4171-65780

	
2.4       Sleeve

	
stent is wrapped with a polymer sleeve (PET)

	
2.5       Supplier (Sleeve)

	
InspireMD

Menorat Hamaor st'

Tel Aviv 67448

Israel

	
2.6       Catheter

	
Type:  ORBUS 1a Blue

balloon expanding, rapid exchange Catheter

	
2.7       Supplier (catheter)

	
BMT Bavaria Medizintechnologie

Argelsrieder Feld 8

D-82234 Oberpfaffenhofen

Germany

Tel.-No.:  +49 815340160

	
2.8       Contracts

	
Development Agreement, 22.09.2006

 

Guidelines for Cooperation between QualiMed and InspireMD, 22.09.2006

	
2.9       Certificates

	
BMT is ISO9001 and ISO 13485 certified (by LGA/InterCert; valid until 01.04.2009)

 

InspireMD is ISO 13485 certified (by the Standard Institute of Israel valid until 31.03.2008)

 

QualiMed:  Double S Stentimplantationssystem is certified by DEKRA-ITS Certification Services (93/42/EWG); valid until 30.03.2008

 

  

  

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

	
3

	
Specification – Requirements – Tolerances / Spezifikation – Anforderungen – Toleranzen

	 	
3.1 

	
Bare Stent, small QM222

 

	
Item

	
Specification

	
3.1.1           Application area

	
coronary stent

	
3.1.2           Description

	
balloon expandable Stainless Steel Stent

	
3.1.3           Raw Material

	
Stainless Steel according to DIN EN ISO 5832 Part 1

	
3.1.4           Tube dimension (for QM222)

	
1,60 x 0,14 mm

	
3.1.5           Manufacturing

	
laser cut tube und electro-polishing

	
3.1.6           Architecture

	
Multicellular

	
3.1.7           Stent length

	
12, 15, 19, 24, 29, 34, 39 mm

	
3.1.8           Opening ranges small

	
2,0; 2,25; 2,5; 2,75; 3,0 mm

	
3.1.9           Mechanism

	
Balloon expandable

	
3.1.10         Coating

	
No

	
3.1.11         Design, small, QM222

	  

 

  

  

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

	 	
3.2

	
Technical Data, small – Stent, QM222

 

	
Nominal stent length

	
12 mm

	
15 mm

	
19mm

	
24mm

	
29mm

	
34mm

	
39mm

	
Technical data

	
QM

222-12

	
QM

222-15

	
QM

222-19

	
QM

222-24

	
QM

222-29

	
QM

222-34

	
QM

222-39

	
3.2.1           Technical data approval date

	
26.07.2007

	
3.2.2           Strut breadth segment (mm)

	
0,108

	
0,108

	
0,108

	
0,108

	
0,108

	
0,108

	
0,108

	
3.2.3           Strut breadth connect (mm)

	
0,082

	
0,082

	
0,092

	
0,092

	
0,092

	
0,092

	
0,092

	
3.2.4           Strut thickness (polished) (mm)

	
0,107

	
0,107

	
0,107

	
0,107

	
0,107

	
0,107

	
0,107

	
3.2.5           Projected surface area (mm2)

	
13,81

	
19,25

	
21,64

	
29,03

	
35,01

	
41,96

	
45,90

	
3.2.6           Total surface area (mm2)

	
56,86

	
76,37

	
89,08

	
119,48

	
141,05

	
167,89

	
189,98

	
3.2.7           Volume of material (mm)

	
1,478

	
2,059

	
2,316

	
3,106

	
3,747

	
4,490

	
4,911

	
3.2.8           Stent length (non-polished) (mm)

	
11,47

	
14,97

	
18,72

	
24,22

	
29,22

	
34,22

	
39,22

	
3.2.9           Percentage of surface* [%]

	
15,3

	
16,4

	
14,7

	
15,3

	
15,3

	
15,6

	
14,9

*calculated on Balloon diameter 2,5 mm.

 

  

  

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

	 	
3.3

	
Bare Stent, medium QM214

 

	
Item

	
Specification

	
3.3.1           Application area

	
coronary stent

	
3.3.2           Description

	
balloon expandable Stainless Steel Stent

	
3.3.3           Raw Material

	
Stainless Steel according to DIN EN ISO 5832 Part 1

	
3.3.4           Tube dimension (for QM214)

	
1,80 x 0,15 mm

	
3.3.5           Manufacturing

	
laser cut tube und electro-polishing

	
3.3.6           Architecture

	
multicellular

	
3.3.7           Stent length

	
12, 15, 19, 24, 29, 34, 39 mm

	
3.3.8           Opening range, medium

	
3,25; 3,5; 4,0 mm

	
3.3.9           Mechanism

	
Balloon expandable

	
3.3.10         Coating

	
No

	
3.3.11         Design, QM214; medium

	  

 

  

  

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

	 	
3.4

	
Technical Data, Medium – Stent QM214

 

	
Nominal stent length

	
12 mm

	
15 mm

	
19mm

	
24mm

	
29mm

	
34mm

	
39mm

	
Technical data

	
QM

214-12

	
QM

214-15

	
QM

214-19

	
QM

214-24

	
QM

214-29

	
QM

214-34

	
QM

214-39

	
3.4.1           Technical data approval date

	
26.07.2007

	
3.4.2           Strut breadth segment (mm)

	
0,115

	
0,115

	
0,115

	
0,115

	
0,115

	
0,115

	
0,115

	
3.4.3           Strut breadth connect (mm)

	
0,075

	
0,075

	
0,075

	
0,085

	
0,085

	
0,085

	
0,085

	
3.4.4           Strut thickness (polished) (mm)

	
0,117

	
0,117

	
0,117

	
0,117

	
0,117

	
0,117

	
0,117

	
3.4.5           Projected surface area (mm2)

	
16,01

	
20,13

	
25,98

	
34,14

	
40,00

	
47,81

	
53,24

	
3.4.6           Total surface area (mm2)

	
57,30

	
84,60

	
109,57

	
143,51

	
168,72

	
201,51

	
230,97

	
3.4.7           Volume of material (mm)

	
1,874

	
2,355

	
3,040

	
3,994

	
4,680

	
5,594

	
6,229

	
3.4.8           Stent length (non-polished) (mm)

	
11,47

	
14,72

	
18,72

	
24,22

	
29,13

	
34,22

	
39,24

	
3.4.9           Percentage of surface* [%]

	
12,7

	
12,4

	
12,6

	
12,8

	
12,5

	
12,7

	
12,3

*calculated on Balloon diameter 2,5 mm.

 

  

  

  

 

	
QM – Formblatt

Design-Brief (DB)

	
QFB 182_05

	
QualiMed*

Innovative Medizinprodukte GmbH

	
Mguard-SIS

	
Seite:   von 10

	
Manufacturing Agreement

- Schedule B

 

	 	
3.5

	
Sleeve

 

	
Item

	
Specification

	
3.5.1           Application area

	
Sleeve placed on the coronary Stent

	
3.5.2           Description

	
PET sleeve Elastic

	
3.5.3           Raw Material

	
Polyethylenterephthalat (PET)

Haemo- and Biocompatible

	
3.5.4           Manufacturing

	
Sleeve is attached to the outside surface, according to SOP1*

Knitting SOP-014-07

Presecuring SOP-015-07

Securing SOP-016-07

Cleaning SOP-017-07

Drying and Vacuum control SOP-018-07*

Crimping and vial packaging SOP-019-07

Handling storage and shipping SOP-024-07

	
3.5.5           Architecture

	
Machine threaded, Multicellular

	
3.5.6           Sizes

	
Small, medium and large,

in different lengths 12, 15, 19, 24, 29, 34, 39 mm

	
3.5.7           Sleeve Small

	
Article- No.:  PSL-0001-V0

	
3.5.8           Sleeve Medium

	
Article- No.:  PSL-0002-V0

	
3.5.9           Sleeve Large

	
Article- No.:  PSL-0003-V0

	
3.5.10         Determination

	
Meshes on the sleeve £ 1 run out

One run out is deemed to be uncritical at the expanded sleeved stent

____________________

1 SOP = Standard operation procedure

 

  

  

  

 

Schedule D

 

To the QualiMed – Inspire Manufacturing Agreement:

 

Prices, Delivery Addresses and Terms

 

The price for each MGuard Stent Implantation System will be calculated according to a two phase pricing model:

 

Monthly Orders – the Company will pay the Manufacturer a price per stent in accordance with the number of stents purchased per month, as depicted in the following table.

 

	
Stents Purchased per Month

	
Stent*

	
Add –ons**

	
System

	 	
Month

	 	 	 	 	
Euro

	
Euro

	
Euro

	 	
stents

	
Euro

	
From

	
- 

	
Up to

	
500

	
40.0

	
109.5

	
149.5

	
X

	
500

	
74,750

	 	 	 	 	 	 	 	 	 	 
	
From

	
501

	
Up to

	
1,000

	
40.0

	
99.0

	
139.0

	
X

	
500

	
69,500

	 	 	 	 	 	 	 	 	 	 
	
From

	
1,001

	
Up to

	
2,000

	
40.0

	
88.5

	
128.5

	
X

	
1,000

	
128,500

	 	 	 	 	 	 	 	 	 	 
	
From

	
2,001

	
Up to

	
4,000

	
40.0

	
82.5

	
122.5

	
X

	
2,000

	
245,000

 

Annual Incentive Plan – the Manufacturer will rebate the Company with respect to the number of stents purchased per year. The rebate will be equal to the difference between the price per stent correlated with the annual number of stents purchased, as depicted in the following table, and the actual payments to the Manufacturer. For the purpose of calculation of the rebate, a “year” shall start on October 1st and end on September 30th. Rebates shall be calculated 30 days following the yearend.

 

  

 

  

 

	
Stents Purchased per Year

	
Stent*

	
Add –ons** 

	System	 	
Year

	 	 	 	 	
Euro

	
Euro

	Euro	 	
stents

	
Euro

	
From

	
- 

	
Up to

	
6,000

	
40.0

	
109.5

	
149.5

	
X

	
6,000

	
897,700

	 	 	 	 	 	 	 	 	 	 
	
From

	
6,001

	
Up to

	
12,000

	
40.0

	
99.0

	
139.0

	
X

	
12,000

	
1,668,000

	 	 	 	 	 	 	 	 	 	 
	
From

	
12,001

	
Up to

	
24,000

	
40.0

	
88.5

	
128.5

	
X

	
24,000

	
3,084,000

	 	 	 	 	 	 	 	 	 	 
	
From

	
24,001

	
Up to

	
48,000

	
40.0

	
82.5

	
122.5

	
X

	
48,000

	
5,880,,000

 

*The transfer price of the bare metal stent (BMS, electropolished, cleaned and quality controlled) which will be delivered to Inspire by QualiMed is € 40 / per stent, not depending on the quantity ordered.

 

**The add-ons include the catheter, crimpimg, sterilization, packaging and labeling of the MGuard Stent Implantation System.

 

The products will be delivered 30 days after written purchase order, according to section 2.-4. of the Manufacturing Agreement.

 

  

 

  

   

	
Date:24.09.2007

 

 

/s/ Manfred Guilder

	 	
Date:25.09.2007

 

 

/s/ Asher Holzer and /s/ Shmuel Behar

	
 

QualiMed Innovative 

 

Medizinprodukte GmbH

 

 

Represent by

 

Name: Manfred Guilder

 

Title:   Managing Director

	  	
 

Inspire MD Ltd.

 

 

 

 

Represent by

 

Name: Asher Holzer

 

Title:   President

 

 

Name: Shmuel Behar

 

Title: CFOUnassociated Document

DEVELOPMENT AGREEMENT

This Agreement (the “Agreement”) is made and entered on the 15 day of January 2007 (the “Effective Date”), by and between InspireMD Ltd., a company duly organized and existing under the laws of the State of Israel having a principal place of business at 4 Derech Hashalom St. Tel Aviv, Israel (“Inspire”), and Qualimed Innovative Medizinprodukte GmbH having a principal place of buisness at Boschstraße 16, 21423 Winsenan, Germany (”Qualimed”).

 

	
WHEREAS

	
Inspire is engaged in the research, development, manufacturing and marketing of a new technology for “Laminar Angiographic Protective Device for Stents” (the “Sleeve”) defined in Exhibit A to this Agremeent); and

	
WHEREAS

	
Qualimed wishes to obtain the Sleeve from Inspire for the purpose of its integration into the Product, all under the terms set forth in this Agreement; and

	
WHEREAS

	
Qualimed is engaged in the production of stents, and shall produce the stent under the terms of this Agreement per the specifications defined in Exhibit B to this Agreement;

	
WHEREAS

	
Qualimed is further engaged in the integration of the stent, Sleeve and the delivery system (collectively reffered to as “Product”) defined in Exhibit C  to this Agreement, and further wishes to obtain a CE mark for the Product; and

	
WHEREAS

	
The parties wish to develop, market, distribute and sell the Product under InspireMD brand name;

NOW THEREFORE, in consideration of the mutual promises and covenants contained herein, the parties hereto hereby agree as follows:

 

	
  

	
1.

	
Preamble and Exhibits: The preamble to this Agreement and the Exhibit form an integral part of this Agreement.

	
  

	
2.

	
Qualimed Representations and Undertakings:

a.     Qualimed hereby represents and warrants to Inspire that it possesses and will maintain throughout the term of this Agreement, the means, experience, know-how, skill, facilities and personnel to properly fulfill its obligations under this Agreement in a timely manner and that it will use its best efforts to peform its obligations under this Agreement. Further, Qualimed represents and warrants that it is duly licensed to execute its obligations under this Agreement.

b.     Qualimed shall comply with any and all national German safety regulations and standards and such other regulations or requirements as are or may be promulgated by authorized national German governmental authorities and required in order to carry out the terms of this Agreement and all other regulations applicable to the sale of the Product per territory where Product is sold.  Qualimed shall provide Inspire information of adverse events or any information that alleges Product deficiencies may related to safety, within three working days from the time that Qualimed becomes aware of such information. Qualimed shall provide Inspire, in timely manner, information that alleges Product deficiencies related to the identity, quality, durability, reliability, effectiveness, or performance all in accordance with the standards listed in Exhibit D to this Agreement (“Standards”).

 

  

page: 1 of 18

  

 

c.     Qualimed undertakes that is shall be responsible for obtaining any and all permits, approvals, licenses, authorizations and clearances from local, state, municipal, governmental, quasi-governmental and other authorities, required per the Standards necessary or desirable for the sake of manufacturing the Product and for the performance of the manufacturing according to the Manufacturing Agreement attached as Exhibit H to this Agreement.

d.     Qualimed undertakes to refrain from manufacturing, producing, marketing, handling or selling (the “Activities”), directly or indirectly, products which compete, or may compete, with the Product, specifically,  with respect to stents covered with a mesh equal or similar to the Sleeve for the term of this Agreement and for a period of 3 years thereafter. For the purpose of clarity, it is noted that Qualimed may engage in the Activities using any form of stents and/or delivery systems, as well as other stent cover materials, so long as the Sleeve or similar material is not used in such Activities.

e.     Qualimed undertakes for the purpose of this Agreement to audit Inspire in all matters relating to Inspire’s manufacruting of the Sleeve, as well as its facility and capabilities, including, but not limited to all requirements Inspire must meet in order to be considered an approved subcontractor of the Product to be marketed, distributed and sold as a medical device world wide.

f.     Qualimed represents that it is duly insured with all relevant insurance policies covering all of its activities under this Agreement and damages that may result of this Agreement, or use of the Product.

g.     Qualimed represents that it has independently developed and it is the rightful owner of all of Qualimed’s intellectual property detailed in Exhibit J to this Agreement that is embedded and/or used, and/or integrated in the Product, and that use and/or integration of said intellectual property does not infringe the intellectual property or contractual rights of third parties.

	
  

	
3.

	
Inspire Representations and Undertakings:

a.     Inspire hereby represents and warrants to Qualimed that it possesses and will maintain throughout the term of this Agreement, the means, experience, know-how, skill, facilities and personnel to properly fulfill its obligations under this Agreement in a timely manner and that it will use its best efforts to peform its oblitgations under this Agreement. Further, Inspire represents and warrants that it is duly licensed to execute its obligations under this Agreement.

b.     Inspire shall provide Qualimed with all information relating to the Sleeve which may be required by Qualimed for the productions of the Product all under the terms of this Agreement.

c.     Inspire shall provide Qualimed with Sleeve Warranty as detailed in Exhibit F to this Agreement.

	
  

	
4.

	
Specifictions listed in this Agreement for the prupose of manufacturing of the Product, including all of its components shall be the responsilibty of the party listed in the table below. Each party undertakes to use its best effort to provide all information required for the definition of the specifications defined below:

	
Product Component

	
Specification Definition

	
Producer/ Integrator

	
Sleeve

	
Qualimed

	
Inspire

	
Stent

	
Qualimed & Inspire

	
Qualimed

	
Stent Compatible Delivery System

	
Qualimed

	
Qualimed

	
Integrated Product

	
Qualimed & Inspire

	
Qualimed

  

  

2

  

 

Qualimed expenses incurred with respect to drafting of the Specifications listed above shall be borne by Inspire as provided for in Exhibit G to this Agreement.

	
  

	
5.

	
Qualimed shall manufacture the stent in accordance with the specifications listed in Exhibit B to this Agreement and subject to the requirements of the Standards applicable to such products.

	
  

	
6.

	
Qualimed shall manufacture the delivery system in accordance with the specifications listed in Exhibit E to this Agreement and subject to the requirements of the Standard applicable to such products.

	
  

	
7.

	
Inspire shall manufacture the Sleeve in accordance with the specifications specified in Exhibit A for the purpose of integrating the Sleeve with the Product. Upon completion of the manufcaturing of the Sleeve by Inspire, it shall preform quality assurance and quallity control tests to the Sleeve manufactured, based on its self established procedures. Tested Sleeve shall be then transferred to Qualimed by Inspire at Inspire’s cost. For the purpose of this section, Inspire shall exercise its best effort obtain ISO approval for the Sleeve mesh manufacturing within 5 months from the Effective Date of this Agreement. Delays that are not a result of Inspire actions or that are out of Inspire’s control shall not be considered Inspire’s failure to preform under this Section. Upon receipt of said ISO approval, Inspire shall forward Qualimed a copy of the documents demonstrating receipt of said approval.

	
  

	
8.

	
Upon receipt of the Sleeve by Qualimed,  it shall preform quality Assurance (“QA”) and Quality Control (“QC”) tests as well as the required bench tests to the Sleeve per pre defined procedured to be furnished by Qualimed to Inspire in writing. Further, Qualimed shall audit Inspire as manufacturer of the Sleeve and provide Inspire with written reports summarizing its conclusions. Said QA and QC tests are attached as Exhibit I to this Agreement. Should defects be found in the Sleeve, Inspire shall have 10 days to evaluate the claimed defect and suggest a solution which shall be forwarded to Qualimed for its approval and/or for further dicussion. Once the solution is jointly approved of by the parties, the parties shall jointly determine the number of days Inspire shall have to implement said solution. Once Qualimed has established that said Sleeve has completed the QA and QC stage successfully (the “Approved Sleeve”), it shall furnish Inspire with an audit report, and Inspire shall be deemed to have fullfilled its obligations under this Agreement.

 

For the purpose of this section Qualimed shall be responsible and liable for executing the required QA and QC tests, all in accorance with the required Standards and Product requirements.

	
  

	
9.

	
Qualimed as the manufacturer of the Product, shall obtain a CE Mark for the Product, under its name, subject to the terms set herein:

a.     For the purpose of pefroming its obligation under this Section, Qualimed shall render the services of Dekra Certification. Inspire shall provide all assistance and documentation required for obtaining such CE Mark.

 

  

3

  

 

b.     Qualimed shall obtain the CE Mark 8 months from the Effective Date of this Agreement. Inspire may terminate this Agreement if the CE Mark is not obtained within a 10 months period, in which case each party shall be the owner of its property and rights as was prior to the Effective Date of this Agreement.

c.      Qualimed shall furnish Inspire with all required documentation demonstrating that the Product has obtained a CE Mark. 

d.      In consideration for Qualimed’s completion of all of its obligations under this Section 9, Inspire shall pay Qualimed the consideration as detailed in Exhibit  G to this Agreement.

 

	
10.

	
Qualimed shall manufacture the Product by integrating the Approved Sleeve with the Stent and the Delivery System. The completed fully integrated Product will be distributed worldwide exclusively by Inspire under its brandname, all under the terms and conditions of a Manufacturing Agreement to be agreed upon by the parties and attached to this Agreement as Exhibit H.

11.           Inspire shall place orders with Qualimed for the Product, as per Exhibit H to this Agreement.

12.           Qualimed and Inspire shall each idetify key persons which will serve as coordinators for the purpose of this Agreement including the execution of its exhibits. Each party undertakes to assign the identified key person, or person of equal skills for said purpose. Qualimed key person shall provide Inspire with progress reports detailing the work performed with respect to the work plan as defined in the Manufacturing Agreement or as part of this Agreement. Said reports shall be provided in writing upon Inspire’s request and at least on a quarterly basis.

13.           It is agreed upon between the parties that all rights related to the Product, including, but not limited to the right to manufacture, distribute, market and sell the product shall be exclusively owned by Inspire. Further, it is agreed upon between the parties that:

a. All intellectual property rights subsisting in or related to the Product, excluding Qualimed’s pre-existing intellectual property as defined in Exhibit J to this Agreement, including but not limited to patents and other know-how and copyright, both registered and unregistered, owned and/or otherwise used by Inspire and all goodwill related thereto (collectively, the “IP Rights”) are and shall remain at all times, as between Inspire and Qualimed, the exclusive property of Inspire and may not be exploited, reproduced or used by Qualimed except as expressly permitted in this Agreement;

b. Qualimed shall not have or acquire any right, title or interest in or otherwise become entitled to any IP Rights by taking delivery of, making payment for, distributing and/or selling or otherwise using or transferring the Product; and

c. Qualimed shall take all reasonable measures to ensure that all IP Rights of Inspire shall remain with Inspire, including promptly notifying Inspire of any possible infringement by third parties of Inspire’s IP Rights and participating with Inspire, at Inspire’s expense, regarding any legal action against such infringement that, in Supplier’s sole judgment, is necessary.

 

  

4

  

 

d. Inspire may at any time affix in any manner its trade name, service marks or trademarks or any of them (the “Trademarks”) to the Product and use the Trademarks in relation to any services or product Inspire provides;

e. Qualimed shall not have or acquire any right, title or interest in or otherwise become entitled to use any Trademarks, either alone or in conjunction with other words or names, or in the goodwill thereof, without the express written consent of Inspire in each instance. Further, Qualimed agrees not to apply for or oppose registration of any trademarks, including the Trademarks, used by Inspire.

f.  Qualimed acknowledges that no license or right is granted hereby with respect to Inspires’s intellectual property other than a license to use the Sleeve for integration in the Product to be distributed by Inspire.

g. Qualimed shall not during the term of this Agreement, or upon its expiration, challenge the validity of Inspire’s Intellectual Property Rights.

 

14.           The Parties agree that nothing contained in this Agreement shall be construed as conferring on either party any right or imposing any obligation to use in advertising, publicity or otherwise any trademark, name or symbol of the other party, or any contraction, abbreviation or simulation thereof, except as expressly provided for in this Agreement.

15.           Without the written consent of the other party, neither party shall disclose to any third party, or use for its own benefit or the benefit of others, either during or after the Term of this Agreement, any confidential or proprietary business or technical information of the other party that has been identified as confidential or proprietary by the disclosing party.

a. To be considered proprietary information, the information must be (i) disclosed in writing or other tangible form and marked confidential or proprietary, or (ii) disclosed orally or visually, identified as confidential at the time of disclosure and reduced to writing and marked confidential or proprietary within thirty (30) days of the disclosure thereof.

b. Proprietary information shall not include information which (i) is already rightfully known or becomes rightfully known to the receiving party independent of proprietary information disclosed hereunder; (ii) is or becomes publicly known through no wrongful act of the receiving party; (iii) is rightfully received from a third party without similar restrictions and without breach of this Agreement; or (iv) in the opinion of counsel, is required to be disclosed to comply with any applicable law, regulation or order of a government authority or court of competent jurisdiction, which event the receiving party shall, prior to such disclosure, advise the other party in writing of the need for such disclosure and use its reasonable best efforts to obtain confidential treatment of such information.

c. The parties agree to keep this Agreement, including all its Exhibits confidential.

 

	
16.

	
It is understood by the parties hereto that the confidentiality, development rights and non-competition undertaking shall be valid as of the date hereof and shall survive the termination of the Agreement.

 

  

5

  

 

17.           The parties agree that each does not have the right or the power to bind the other in any way. Further, this Agreement shall not be deemed to create any employer-employee relationship between the parties, nor any agency, franchise, joint venture or partnership relationship between them.

18.           may assign its rights under this Agreement provided that the Product to be manufactured under this Agreement is not effected by such change.

19.           Qualimed shall indemnify, hold harmless and defend Inspire, its successors and assigns for all losses, claims and defense costs claimed by any third party for any injury, death or property damage suffered by such third party to the extent resulting from a defect in the manufacturing of the Product supplied hereunder, unless such injury, death or property damage is the result of Inspire’s negligence or willful misconduct.

20.           Inspire assumes no liability for infringement claims arising from (i) the combination of the Sleeve with Qualimed products where such claim would not have arisen from the use of the Sleeve standing alone (ii) any modification of the Sleeve not made by or under the authority of Inspire, where such infringement would not have occurred but for such modifications; (iii) from any continued use by Qualimed of the allegedly infringing Sleeve after being provided modifications that would have avoided the infringement and (iv) Qualimed’s use of the allegedly infringing Sleeve in violation of this Agreement.

21.           The term of this agreement shall be for 10 years Inspire may terminate this agreement with a written 30 days notice, should any one of the following occur:  (i) interruption of supply on part of Qualimed; (ii) Production of Product by Qualimed not accordance with the Product Specifications listed in Exhibit C to this Agreement (iii) Production of the Stent by Qualimed not accordance with the Stent Specifications listed in Exhibit B to this Agreement (iv)an adverse change in Qualimed’s financial situation which leads to its inability to preform its obligations under this Agreement;

 

Upon termination, all rights and licenses granted hereunder shall immediately terminate and automatically revert to their owner. In case of either Party’s uncured material breach, the Party in breach shall return to the non-breaching Party or destroy the Intellectual Property including all copies and documentation, and shall provide written notice to non-breaching Party of such return or destruction to within 60 days of termination.

 

22.           The following Sections will survive expiration or termination of this Agreement: 2,3,13,15,16,18,19,20,24 and 25.

23.           This Agreement, and Qualimed’s rights and obligations hereunder, shall not be assigned in whole or in part by Qaulimed without the prior written consent of Inspire.  Any attempted assignment or delegation without such consent shall be void and of no effect.

24.           This Agreement shall be governed by, and construed in accordance with, the laws of Switzerland applicable to contracts made and to be performed therein, without giving effect to the principles of conflicts of law.

 

  

6

  

 

25.           All disputes arising directly under the express terms of this Agreement or the grounds for termination thereof shall be resolved as follows: The senior management of both Parties shall meet to attempt to resolve such disputes.  If the disputes cannot be resolved by the senior management, either Party may make a written demand for formal dispute resolution and specify therein the scope of the dispute.  Within thirty days after such written notification, the Parties agree to meet for one day with an impartial mediator and consider dispute resolution alternatives other than litigation.  If an alternative method of dispute resolution is not agreed upon within thirty days after the one day mediation, either Party may begin litigation proceedings subject to section 26 below.

26.           The parties hereto irrevocably submit to the exclusive jurisdiction of the courts of the defending party, with respect to any dispute or matter arising out of, or connected with, this Agreement.

27.           The failure of the party to enforce at any time any provisions of this Agreement shall in no way be construed to be a waiver of such provision or any other provision hereof.

28.           This Agreement shall be binding upon the heirs, executors, administrators and successors of the parties hereof.

29.           This Agreement may be executed in counterparts, and all such counterparts together shall be deemed to be the original and will constitute one and the same instrument. A facsimile signature shall be deemed as an original for all purposes.

30.           All notices and other communications required or permitted hereunder to be given to a party to this Agreement shall be in writing and shall be telecopied or mailed by registered or certified mail, postage prepaid, or otherwise delivered by hand or by messenger, addressed to such party’s address as set forth in the preamble above or at such other address as the party shall have furnished to the other party in writing in accordance with this provision.

31.           Any notice sent in accordance with Section 22 shall be effective (i) if mailed, seven (7) business days after mailing, (ii) if sent by messenger, upon delivery, and (iii) if sent by telecopier, upon transmission and electronic confirmation of receipt or, if transmitted and received on a non-business day, on the first business day following transmission and electronic confirmation of receipt.  Any notice of change of address shall only be valid upon receipt.

32.           This Agreement constitutes the entire understanding between the parties hereto.  Any prior agreement, arrangements or understandings, verbally or in writing, between the Consultant and the Company, and any right generated from such is hereby void.  Any change of any kind to this Agreement will be valid only if made in writing, signed by both the Consultant and the Company's authorized member and approved by the Board.

 

  

7

  

 

IN WITNESS WHEREOF THE PARTIES HERETO HAVE SIGNED THIS AGREEMENT AS OF THE DATE HEREINABOVE SET FORTH:

 

 

	 	
InspireMD Ltd.

	 	
Qualimed Innovative

Medizinprodukte GmbH

	 	 	 	 
	 	/s/ Offir Paz	 	/s/ Dipl.-Ing. Markus Binder
	By:	 
Chief Executive Officer

	By:	 
Dipl.-Ing. Markus Binder

 

Agreement Exhibits:

Exhibit A: Sleeve Product Specifications (Defined by Qualimed)

Exhibit B: Stent Specifications (Defined jointly by Inspire and Qualimed)

Exhibit C: Product Specifications (Defined jointly by Inspire and Qualimed)

Exhibit D: Product Standards

Exhibit E: Delivery System Specifictions (Defined by Qualimed)

Exhibit F:  Sleeve Product Warranty (Provided by Inspire)

Exhibit G: Qualimed Consideration

Exhibit H: Manufactruing Agreement Inspire-Qualimed

Exhibit I: QA and QC testing for the Sleeve provided by Qualimed.

Exhibit J: Qualimed Pre existing IP

 

  

8

  

 

EXHIBIT A

Sleeve Product Specifications to be provided by Inspire

 

1.2           Sleeve

 

	
Item

	
Specification

	
Reference

	
Application area

	
Sleeve placed on the coronary stent

	
PHD MGC-I-06

	
Description

	
PET sleeve elastic

	
PHD MGC-I-06

	
Raw Material

	
Polyethylenterephthalate (PET)

haemo- and biocompatible

	
PHD MGC-I-06

	
Manufacturing

	
Sleeve is attached to the outside surface, according to

	
PHD MGC-I-06

	  	
SOP

	  
	  	
Knitting SOP-014-07

	  
	  	
Pre securing SOP-015-07

	  
	  	
Securing SOP-016-07

	  
	  	
Cleaning SOP-017-07

	  
	  	
Drying and Vacuum control SOP-018-07”

	  
	  	
Crimping and vial packaging SOP-019-07

	  
	  	
Handling storage and shipping SOP-024-07

	  
	
Architecture

	
Machine threaded, multi cellular

	
PHD MGC-I-06

	
Sizes

	
Small, medium and large,

in different lengths 12, 15, 19, 24, 29, 34, 39 mm

	
PHD MGC-I-06

	
Sleeve small

	
Article- No.: PSL-0001-V1

	
PHD MGC-I-06

	
Sleeve medium

	
Article- No.: PSL-0002-V1

	
PHD MGC-I-06

	
Sleeve large

	
Article- No.: PSL-0003-V1

	
PHD MGC-I-06

	
Determination

	
Meshes on the sleeve ≤ 1 run out

One run out is deemed to be uncritical at the expanded

sleeved stent

	
PHD MGC-I-06

 

  

9

  

 

EXHIBIT B

Stent Specifications

 

1.           Technical data

 

1.1         Bare Stent

 

	
Item

	
Specification

	
Reference

	
Application area

	
Coronary stent

	
PHD MGC-I-06

	
Description

	
Balloon expandable Stainless Steel stent

	
PHD MGC-I-06

	
Raw Material

	
Stainless Steel according to

DIN EN ISO 5832 Part 1

	
PHD MGC-I-06

	
Manufacturing

	
laser cut tube, electro-polished

	
PHD MGC-I-06

	
Architecture

	
Multi cellular

	
PHD MGC-I-06

	
Stent length

	
12, 15, 19, 24, 29, 34, 39 mm

	
PHD MGC-I-06

	
Mechanism

	
Balloon expandable

	
PHD MGC-I-06

	
QM222 small stent

	  	  
	
Tube dimension

	
1.60 x 0.14 mm

	
PHD MGC-I-06

	
Opening ranges

	
2.00; 2.25; 2.50; 2.75; 3.00 mm

	
PHD MGC-I-06

	
Technical data approval date

	
18.01.2008

	
PHD MGC-I-06

	
QM214 medium stent

	  	  
	
Tube dimension

	
1,80 x 0,15 mm

	
PHD MGC-I-06

	
Opening ranges

	
3.25; 3.50; 4.00 mm

	
PHD MGC-I-06

	
Technical data approval date

	
15.01.2008

	
PHD MGC-I-06

 

  

10

  

 

EXHIBIT C

Product Specifications

The product is comprize from :

	
  

	
a.

	
a mesh as per specification submited from time to time by inspiremd

	
  

	
b.

	
a delivary catheter (BTM) the new genaration cat number ........ series

	
  

	
c.

	
stent design low profile compitable with new genaration ballons up to 6mm diameter

 

  

11

  

 

EXHIBIT D

Product Standards

 

	
1.

	
Essential Requirements list according to MDD 93/45.

 

	
2.

	
ISO 10993 Biological evaluation of medical devices

 

	
3.

	
ISO 14971-2000 Risk Management

 

	
4.

	
ISO 13485-2003 Quality Systems

 

	
5.

	
ISO 14644 Clean Rooms

 

	
6.

	
ISO 980 Labeling

 

	
7.

	
ISO 11135 – Medical Devices – Validation and routine control of ethylene oxide sterilization.

 

	
8.

	
EN 550– Sterilization of medical devices – Validation and routine control of ethylene oxide sterilization.

 

	
9.

	
ASTM 868 Packaging

 

	
10.

	
EN 1041 – Instructions for Use – Medical Devices

 

	
11.

	
ISO 14155 Clinical Investigation of Medical Devices

 

	
12.

	
ISO 9001

 

	
13.

	
ISO 13485

 

	
14.

	
MMD 93/42/EEC

 

  

12

  

 

EXHIBIT E

Delivery System Specifictions

 

	
1.3

	
PTCA – Balloon catheter

 

	
1.3.1

	
Orbus 1a blue catheter

	
Item

	
Specification

	
Reference

	
Design

	
Rapid Exchange Catheter, PTCA,

BMT Orbus la blue

	
PHD MGC-I-06

	
Dimension

	
From 2.00 x 11 mm to 4.00 x 40 mm

(diameter x length)

	
PHD MGC-I-06

	
Nominal pressure

	
6 bar

	
PHD MGC-I-06

	
Rated burst pressure

	
Balloon diameters 3.25 mm 16 bar

Balloon diameter > 3.25 mm 14 bar

	
PHD MGC-1-06

	
Balloon characteristic

	
semi compliant

	
PHD MGC-I-06

	
Balloon folding

	
For diameter s 2.25: 2 winged

For diameter a 2.50 up to 4.00: 3 winged

	
PHD MGC-I-06

	
Refold

	
For diameter < 2.50 mm: 2 winged

For diameter z 2.50 mm: 3 winged (up to 12 bar) and 2 winged (from 13 bar)

	
PHD MGC-I-06

	
Direction of balloon folding, regarded from the tip

	
clockwise direction

	
PHD MGC-I-06

	
X ray balloon marker

	
2 markers located at the end of the balloon

	
PHD MGC-I-06

	
Recommended guide wire

	
0.014”

	
PHD MGC-1-06

	
Recommended guiding catheter

	
6F

	
PHD MGC-1-06

	
Maximum deflations time measured with 37°C warm 50/50% water/contrast agent

	
≤ 12 sec (Balloon length up to 30 mm)

	
PHD MGC-I-06

 

  

  

  

 

1.3.2           Natec Tamarin catheter

 

	
Item

	
Specification

	
Reference

	
Design

	
PTCA dilatation catheter, rapid exchange

Natec Tamarin Blue

	
TF-MGC-06_02-A01 QFB405

QPS Natec Tamarin Blue Catheter_080728

	
Dimension

	
From 2.00 x 12 mm to 4.00 x 40 mm (diameter x length)

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
Nominal pressure

	
8 bar

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
Rated burst pressure

	
16 bar or

14 bar from 0 3.5mm and length > 35mm & Ø 4.0mm and length > 30mm

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
Balloon characteristic

	
semi compliant

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter 080728

	
Balloon folding

	
Balloon folded in three wings

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
Refold

	
Yes

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
Direction of balloon folding, regarded from the tip

	
In counter clockwise direction

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
X ray balloon marker

	
2 markers located at the end of the balloon

	
TF-MGC-06_02-AO1 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
Recommended guide wire

	
0.014”

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter_080728

	
Recommended guiding catheter

	
6F

	
TF-MGC-06_02-A01 QFB405 catheter QPS Natec Tamarin Blue Catheter_080728

	
Maximum deflations time measured with 37°C warm 50/50% water/contrast agent

	
10 – 20 seconds according to image 1 in specification

	
TF-MGC-06_02-A01 QFB405 QPS Natec Tamarin Blue Catheter 080728

 

  

13

  

 

EXHIBIT F

Sleeve Product Warranty

 

 

  

14

  

 

EXHIBIT G

Qualimed consideration for the successful execution of its obligations under this Agreement shall be:

(i) 70,000 Euro (the “Cash Consideration”), payable against invoices to be furnished to Inspire for review. The Cash Consideration shall be paid 30 days from date of approval for payment by Inspire. The Cash Consideration shall be the sole and exclusive consideration Qualimed shall be entitled to under this Agreement for any and all expenses it shall incurr. Qualimed shall bear all expenses exceeing the amount of the Cash Consideration.

(ii) In addition to section (i) above, upon obtaining the CE Mark for the Product and the Improved Product (collectively referred to as the “Marks”) and the transfer of Marks under Inspire’s name, Inspire shall grant Qualimed 1,000 Ordinary Shares of Inspire, 45 days from the date on which the documents confirming Mark/s was obtained and transferred were actually received by Inspire. For the sake of clarity it is noted that Qualimed shall not be entitled for any fraction payments under this section (ii) even if it has preformed some of the work or actions required for obtaining and/or transferring the Marks. Qualimed shall bear all tax liability imposed in connection with this section (ii).

 

  

15

  

 

  EXHIBIT H

  Manufactruing Agreement Inspire-Qualimed

 

  

16

  

 

EXHIBIT I

QA and QC testing for the Sleeve to be composed of :

	
  

	
1.

	
Visual Inspection

	
  

	
2.

	
Detailed inspection after crimping

 

  

17

  

 

  EXHIBIT J

  Qualimed Pre Exising IP

2.           Indications

 

The MGC-SIS is indicated for improving vessel luminal diameter in the following cases:

 

	
  

	
·

	
Patients eligible for balloon angioplasty with symptomatic ischemic heart disease or a positive functional ischemia study due to discrete de novo and restenosed coronary artery lesions with a vessel reference diameter matching the final stent nominal diameter.

 

	
  

	
·

	
An elective implantation and in the treatment of acute or threatened closure associated with the coronary intervention, including saphenous vein grafts.

 

3.           Contraindications

 

General contraindications for coronary stenting and for the use of this device are:

 

	
  

	
·

	
Unprotected left main coronary artery disease;

 

	
  

	
·

	
Coronary artery spasm;

 

	
  

	
·

	
Lesions involving a bifurcation;

 

	
  

	
·

	
Cardiogenic shock;

 

	
  

	
·

	
Any patients judged to have a lesion which may prevent proper stent deployment;

 

	
  

	
·

	
Vessel trauma requiring surgical repair or reintervention

 

	
  

	
·

	
Total occlusion of target lesion

 

	
  

	
·

	
Ejection fraction <30%;

 

	
  

	
·

	
Allergies to required procedural medications;

 

	
  

	
·

	
Lesions involving arterial segments with highly tortuous anatomy;

 

	
  

	
·

	
Severe reaction to contrast agents;

 

	
  

	
·

	
Contraindication for anti-platelets and/or anti-coagulation therapy;

 

	
  

	
·

	
Known allergies to Stainless Steel or Polyethelyne Theraphalate.

 

	
  

	
·

	
Cardiac Tamponade

 

	
  

	
·

	
Emboli, distal (air, tissue or thrombotic emboli)

 

	
  

	
·

	
Emergent Coronary Artery Bypass Surgery (CABG)

 

	
  

	
·

	
Pericardial effusion

 

	
  

	
·

	
Pseudoaneurysm, femoral

 

	
  

	
·

	
Respiratory Failure

 

	
  

	
·

	
Shock/Pulmonary edema

4.           Product description

 

The MGuard Coronary Stent System is composed of a coronary Double S stent covered with a polymer sleeve knitted from micron level Poly Ethylene Terephthalate (PET) fiber premounted on an ORBUS 1a blue balloon catheter or a Natec Tamarin catheter, respectively.

 

The MGC allows the secure transport of the stent through the coronary system. The stent can be positioned with the X ray balloon markers in the desired stricture and applied via inflation of the balloon. The balloon inflates the stent covered with the flexible sleeve at nominal pressure to the nominal diameter.

18

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