Document:

Unassociated Document

 

BASIC AGREEMENT

 

	  	
between

	  
	
MeKo Laser Material Processing

(MeKo)

Im Kirchenfelde 12-14

31157 Sarstedt

	
And

	
Inspire MD

(Inspire)

3 Menorat Hamaor St,

67448 Tel Aviv, Israel

 

Introduction

 

This document specifies the details of delivery strategy for electro polished L605 bare metal stents.

 

	
  

	
1.

	
MeKo produces electro polished L605 bare metal slants based on the drawings 43-0003-xx and 43-0004-xx with xx as an replacement for: 8 mm, 13 mm, 18 mm, 23 mm, 28 mm, 33 mm, 38 mm

 

	
  

	
2.

	
For stock production Inspire will send a "Frame order" of the total amount of each length and design for a quarter [as long as not other defined). For partial order Inspire will send "calls" with the amount of each position with at least 100 pieces each length.

 

	
  

	
3.

	
After an initial production time MeKo guarantees the shipment of partial calls from stock within 1 working day (e.g. Call will arrive on Monday the shipment will be sent with UPS at latest on Tuesday)

 

	
  

	
4.

	
The prices will base on the quantity of each length ordered in the Frame Order.

 

	
  

	
5.

	
MeKo will send a stock overview with each shipment.

 

	
  

	
6.

	
As soon as positions run out of parts, a new frame order will be send by Inspire

 

The prices in Dollars will be as listed below:

 

	
Length (mm)

	
200 pc.

	
400 pc.

	
600 pc.

	
800 pc.

	
1000 pc.

	
8

	
25.7

	
22.7

	
21.6

	
21.1

	
20.8

	
13

	
30.4

	
27.4

	
26.4

	
25.9

	
25.6

	
18

	
35.2

	
32.1

	
31.1

	
30.6

	
30.3

	
23

	
39.9

	
36.9

	
35.8

	
35.3

	
35.0

	
28

	
44.6

	
41.6

	
40.6

	
40.1

	
39.8

	
33

	
49.4

	
46.3

	
45.3

	
44.8

	
44.5

	
38

	
54.1

	
51.1

	
50.0

	
49.5

	
49.2

Signature of Company MeKo /s/ Dipl.-Ing. Markus Binder

Signature of Inspire MD          /s/ Eli Bar

 

  

  

  

 

QUALITY ASSURANCE AGREEMENT

 

Between

 

	
Customer:

	
InsperMD Ltd.

 

	
  

	
3 Menorat Hamaor St., Tel-Aviv 67448, Israel

 

and

 

	
Subcontractor:

	
MeKo Laser Material Processing,

 

	
  

	
Im Kirchenfelde 12-14, 31157 Sarstedt, Germany

 

§ 1 Purpose

 

The purpose of this Quality Assurance Agreement is to address and assign all requirements and responsibilities between the companies to assure the manufacturing and supply of medical products of high quality fulfilling the specifications under reliable and reproducible conditions.

 

§ 2 Products and scope of subcontracting service

 

Products: CoCr stent according to specification No. 43-0003-XX and 43-0004-XX

 

Scope of Service: Laser cutting and Electro-polishing.

 

Customer is responsible for the design, drawing, specifications etc. with respect to the characteristic, quality requirements and application of the product.

 

§ 3 Quality Management System of MeKo

 

MeKo will maintain an ISO 13485 quality system and will immediately inform the customer and discontinue product delivery if it is forfeiting its ISO 13485 certificate.

 

§ 4 Orders

 

Customer orders will include or reference to

 

	
  

	
·

	
order number and delivery date,

	
  

	
·

	
drawing number and revision date or number,

	
  

	
·

	
all specifications and requirements and

	
  

	
·

	
any additional information,

 

which are necessary to manufacture the products (see § 2),

 

MeKo will accept purchase orders only when it has been determined the documents, materials, components, calibrated/maintained/validated equipment and trained personnel, as appropriate, are available to meet the requirements for the scheduled delivery.

 

  

  

  

 

§ 5 Raw material and Incoming Inspection

 

For the products (notified in § 2) MeKo ensures to use only raw material

 

	
  

	
·

	
provided by the customer and/or

	
  

	
·

	
From a qualified supplier. The qualification of the supplier has to be assured either by an ISO 13485 certificate or quality audits performed by MeKo.

 

MeKo procures the material, MeKo is responsible for the adequate incoming inspection in respect of the material and/or product specifications.

 

§ 6 Manufacturing

 

All products shall be manufactured in accordance with the ISO 13485 quality management system of MeKo and the drawing and specification of the customer. In particular (in addition) the following requirements have to be assured:

 

Laser cutting:

 

	
  

	
·

	
Strut width tolerance ± 0.015 mm.

	
  

	
·

	
Laser cut surfaces/edges burr free and free of oxides etc..

 

Heat treatment:

 

	
  

	
·

	
Each heat treatment of a lot is verified by a tensile test. The strain/stress curve of the tensile test will be supplied with the products.

	
  

	
·

	
The minimum break elongation for approval is 50 %.

	
  

	
·

	
For L605 material the LowElast process will be applied to the products.

 

Electro polishing:

 

	
  

	
·

	
Electro polished surfaces have to be shiny and smooth without sharp edges, pitting, etc..

	
  

	
·

	
Strut tolerances after electro polishing ± 0.015 mm.

 

Passivation:

 

	
  

	
·

	
All products have to be passivated in accordance with the MeKo process CorReSurf.

 

Final Cleaning:

 

	
  

	
·

	
All finished products have to undergo a final cleaning process.

	
  

	
·

	
The final cleaning has to ensure a microscopic cleanness of the surface: particle and residual free products.

 

§ 7 Final Inspection of Products

 

MeKo assures the visual inspection of each product (100 % inspection) by utilisation of microscopes with a magnification of 50 x.

 

  

  

  

 

The products have to be free off defects according to the specifications and/or failure catalogue. The surfaces have to be free of particles and residuals of the manufacturing process.

 

The product dimensions are verified during manufacturing whereas the first and the last part of a batch (subset of a lot) are inspected. Only if both parts (the first and the last) are in accordance with the drawing and specification, the batch is released as part of the lot.

 

§ 8 Labelling and Packaging

 

The products will be labelled with

 

	
  

	
·

	
purchase order number

	
  

	
·

	
drawing number and drawing revision

	
  

	
·

	
raw material lot number

	
  

	
·

	
number of products in a package

	
  

	
·

	
date of final inspection and name of inspector

 

The products have to be securely packed to avoid any contamination or harm during transportation.

 

In particular stents have to be packed in plastic/glass vials and the vial in special cardboard boxes with foam grid inside.

 

§ 9 Documentation and Shipment

 

Each product lot will be shipped with the necessary documentation for identification, traceability and proof of conformance with the drawings/specifications including:

 

	
  

	
·

	
delivery note with delivery note number (for traceability)

	
  

	
·

	
Certificate of Conformance (CoC)

	
  

	
·

	
tensile test graph

	
  

	
·

	
necessary documents for customs clearance

 

The products will be shipped via airfreight e.g. by FedEx, UPS or DHL.

 

MeKo will maintain traceability by accurate, controlled, accessible and secured records of material, manufacturing processes, inspections and returns as applicable and in accordance with the IS013485. Documents will be preserved for a period of 15 years.

 

§ 10 Changes in Processes

 

MeKo will inform the customer prior to implementing changes to the production process, which may have an effect to the product quality and which is utilized in manufacturing and inspecting the products including but not limited to changes of material, raw material supplier and equipment.

 

  

  

  

 

§ 11 Incoming Inspection at customer side

 

The customer will perform sample size (AQL ...) or 100 % inspection of the products after receipt of the shipment.

 

In case of product rejection MeKo has to be informed immediately in writing by fax or email. The delivery note number and the number of rejected products should be notified. The rejection reason has to be described in writing and/or with pictures etc. as precisely as possible to enable MeKo to take corrective actions in the manufacturing or final inspection.

 

§ 12 Miscellaneous

 

This Quality Assurance Agreement comprises all quality issues of the products mentioned in § 2, which are necessary in addition to the drawings and specifications released by the customer and sent to MeKo.

 

Any changes of the provisions of this agreement have to be made in written and signed by both companies.

 

	Signature: /s/ Eli Bar	Signature: /s/ Dipl.-Ing. Markus Binder
	Name: Eli Bar	Name: Dipl.-Ing. Markus Binder
	Company: InspireMD	Company: MekoUnassociated Document

 

AGREEMENT

 

This present agreement is concluded between NATEC MEDICAL LTD, Maeva Centre, Business Park Ebene, Reduit, Mauritius (the "Seller") and INSPIRE MD, of 3, Menorat Hamaor St, Tel Aviv 67448, Israel, (the "Buyer").

 

I/ OBJECT

 

This agreement describes the specific terms and conditions between NATEC MEDICAL LTD and INSPIRE MD.

 

II/ PRODUCT COVERAGE

 

This agreement is for the supply of Tamarin Blue PTCA dilatation catheters (bulk, non-sterile), hereinafter referred to as the "Product".

 

III/ PURCHASE SPECIFICATIONS

 

	
A) 

	
Volume commitment

 

Buyer commits to purchase a minimum volume of 10 000 Products for the first year.

 

	
B) 

	
Price

 

The Product price is 40 Euros Exworks.

 

	
C) 

	
Gratuities

 

It is agreed that upon reaching payment of 2,000 units, the Seller will deliver 200 units for free based on the following order. This level of gratuities will be applicable for each following batch of 2 000 units paid.

 

	
D) 

	
Payment terms

 

	
  

	
·

	
By Letter of Credit (60 days at sight) for the first order

	
  

	
·

	
60 days credit based on invoice date, for the following orders

	
  

	
·

	
Handling of new order will be related to effective release of payment of previous order.

	
  

	
·

	
Bank details provided on each Proforma Invoice

	
  

	
·

	
Reimbursing bank to have the Patriot Act Certification with one of the following banks:

 

	1. CITIBANK	
7. BANK OF NEW YORK

	2. JPMORGAN CHASE BANK	
8. FORTIS

	3. DEUTSCHE BANK	
9. HSBC BANK USA

	4. WACHOVIA	

10. WELLS FARGO

	5. AMERICAN EXPRESS	
11. BNPPARIBAS

	6. SOCIETE GENERALE	  

  

  

  

  

 

E)           Price revision

 

The price revision is based on a) usual market price review b) volume (forecast to be provided annually).

 

	
F) 

	
Minimum order quantity

 

Minimum quantity to be ordered per size: 50 pieces.

 

	
G) 

	
Transportation costs

 

These will be fully supported and insured by the Buyer, Ex-works.

 

	
H) 

	
Interest charges for late payment

 

All invoices due to Seller related to the present agreement, and unpaid at their due date, will bear interests at the rate of 2% (two percent) per month above prevailing bank rate in Mauritius, calculated between the due date and the effective payment date.

 

	
I) 

	
Interest charges for late shipment

 

Late shipment, unless otherwise agreed, shall bear interest at the rate Of 2% (two percent) per month to be deducted from the Buyer invoice.

 

IV/ LOGISTICS

 

A)           Order Acknowledgement and delivery schedule

 

An informal initial order acknowledgement is provided within 1 (one) business day. A formal order acknowledgement is sent by Seller to Buyer upon acceptance of payment terms, and provides confirmation of prices and the effective lead-time(s) and delivery/shipment date(s). Delivery/shipment date is the date when the order is ready for pickup by carrier at Seller's production location. The Shipping address/Billing address are to be confirmed by Buyer upon sending of his PO.

 

B)           Regulatory

 

Certificates needed for selling the product referenced in this agreement will be made available by Seller. This involves, without being exhaustive, the ISO and CE certificates, and the Free Sales certificate. Seller will grant access to Buyer to its Technical file, and will give full assistance needed in order to get regulatory clearance.

 

C)           Regional registration

 

Some countries need the registration of the products referenced in this agreement for import and selling authorization. The Seller will make all due efforts to assist the Buyer and / or make the requested registration effective.

 

  

-2-

  

 

V/ DURATION OF AGREEMENT

 

This agreement starts at the date of its signature, for • an unlimited period after the first year. It may be cancelled by each party with a notification of six months done by registered postal mail, subject to the time needed for the Buyer to transfer the registration to a third party product. The agreement may be suspended without delay in case of non application of its terms. The suspension must be notified to the other party's address by registered postal mail within three business days.

 

VI/ FORCE MAJEURE

 

Each party will be excused for reasonable delay in the execution of its obligations, in case of Force Majeure. Each party will make its best efforts to remediate to the situation with reasonable solutions. Each party will inform the other party when such a Force Majeure occurs and no later than 3 business days later, and list the steps scheduled to return to a normal situation.

 

VII/ APPLICABLE LAW and JURISDICTION

 

This Agreement shall be governed by and construed in accordance with Israeli Law and the parties hereby submit to the jurisdiction of the Courts of Israel.

 

VIII/ LIABILITY

 

Once shipped the Seiler shall not be liable for any delay caused by the carrier or customs (taking in consideration that carrier to be used is decided and organized by buyer).

 

	
Seller:

 

	
Buyer:

	
NATEC Medical Ltd.

Managing Director

 

	
INSPIRE MD

CTO & VP R&D

	
/s/ Mrs. Francine Lanceleur

Mrs. Francine Lanceleur

Date: 23/09/2009

	
/s/ Mr. Eli Bar

Mr. Eli Bar

Date: 23/9/2009

 

-3-

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