Manufacturing Agreement - Novoste BV and AorTech Europe Ltd.
CMP1: ASAPER.DOC
D1 1.3.94:D2 4.3.94:D3 6.5.94
D4 9.5.94:D5 10.8.94:D6 29.8.94
D7: 30.8.94
MANUFACTURING AGREEMENT
between
NOVOSTE B.V.
Dillenburgstraat 11a
5652 AM Eindhoven
The Netherlands
(hereinafter referred to as "Novoste B.V.")
and
AORTECH EUROPE LIMITED
Incorporated under the Companies Acts and having
their registered office at Phoenix Crescent
Strathclyde Business Park Bellshill Lanarkshire
ML4 3NJ Scotland (Hereinafter referred to as
"AorTech")
WHEREAS, Novoste Corporation has developed the Product (as
hereinafter defined) and has licensed the related
intellectual property and technology to its
wholly owned subsidiary Novoste B.V., and Novoste
B.V. wishes AorTech to manufacture the Product;
and
WHEREAS, AorTech has agreed to manufacture the Product and
purchase the components therefore,
NOW THEREFORE
1.0 GENERAL UNDERSTANDING
1.1 For the purpose of this agreement, the Product shall mean all
finished devices produced by AorTech at the request of Novoste
B.V.
1.2 During the term of and upon the conditions set forth in this
Agreement, Novoste B.V. appoints AorTech as a European
manufacturer. AorTech accepts such appointment and agrees to
source and procure all required materials for and, assemble,
package, sterilize, label, arrange for the handling, testing,
storage and shipment of the Product, all in accordance with
the terms and specifications hereof. AorTech shall perform its
obligations
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hereunder in a competent and professional manner and in
compliance with applicable law of relevent jurisdictions.
1.3 AorTech shall at its own cost, provide to Novoste B.V.:
a. All labor required to carry out each task described
in 1.2;
b. facilities for performing each task described in 1.2;
c. facilities for storing the Product, its components
and supplies at the premises of AorTech.;
d. qualified personnel for testing of the Product, its
sub-assemblies, components and supplies;
e. qualified personnel to perform preventive and routine
maintenance and calibration of equipment, fixtures
and machines used to manufacture the Product;
f. facilities and personnel to maintain and store all
quality records pertaining to the Product, where they
shall be available for immediate review and shall be
maintained as the property of Novoste B.V.;
g. qualified personnel to assist Novoste B.V. in
transporting materials and finished Product through
customs and into all countries of the European Union;
and
h. qualified personnel to source and procure all
materials required to build the Product as specified
in this Agreement;
1.3 All Products shall be manufactured in accordance with Novoste
B.V.'s specifications and procedures, ISO 9001 procedures and
cGMP.
2.0 PACKAGING OF FINISHED GOODS
2.1 All Products shall be packaged in the manner and with such
wrappers cartons boxes or other containers bearing such
labeling, trade names and trademarks as Novoste B.V. may from
time to time designate and supply to AorTech, provided that
Novoste B.V. shall give AorTech 30 days written notice of any
change thereto.
3.0 SCHEDULING
3.1 AorTech shall manufacture Product for Novoste B.V. hereunder
only upon receipt of purchase orders from Novoste B.V. setting
forth the order number, the quantity and type of Product
ordered and special shipping instructions, if any.
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3.2 Novoste B.V. Materials Management shall periodically issue to
Aortech an updated twelve (12) month Production forecast.
3.3 AorTech and Novoste B.V. agree to use the following scheduling
and material ordering parameters for the purpose of ordering
component inventory and planning Production and engineering
resources:
<TABLE>
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<S> <C>
3 months Firm Purchase Orders from Novoste B.V. for Finished
Product; schedule unchangeable
- ----------------------------------------------------------------------------------------------------------------
4 months (60 days minimum on hand inventory to be Firm commitments from Novoste B.V. for AorTech to
maintained by AorTech; an additional 60 days inventory purchase all material required to produce Products
secured in the form of firm purchase orders from per rolling Production schedule
AorTech per the rolling Production schedule)
- ----------------------------------------------------------------------------------------------------------------
5 to 12 months Novoste B.V. may move up to 30% of scheduled
deliveries out 60 days or in 60 days depending on
material availability and actual market demand
- ----------------------------------------------------------------------------------------------------------------
</TABLE>
3.4 AorTech shall source and procure all materials required for
the manufacture of the Product. AorTech shall use only
approved suppliers listed on AorTech's approved supplier list
when purchasing such material.
3.5 AorTech shall immediately alert Novoste B.V. in writing of
potential or confirmed delays in obtaining material, of the
required amounts, when such a delay may affect Product
delivery dates.
3.6 AorTech shall immediately alert Novoste B.V. in writing of
potential or confirmed material obsolescence or material
substitution issues.
3.7 AorTech shall maintain a minimum of sixty (60) days inventory
of all required materials for the manufacture of the Product
to support the rolling Production forecast over that same time
period. In addition, firm purchase orders from AorTech shall
be outstanding for an additional sixty (60) days supply of
such required materials.
3.8 AorTech shall provide Novoste B.V. on a monthly basis, an
inventory summary review of all material. At minimum the
report will detail the following information: part number and
description per Novoste B.V. specifications, quantity on hand,
quantity on order and due dates, cost, supplier name and
address, supplier approval status, total inventory valuation,
obsolete inventory and valuation, and any potential or pending
issue with the supplier that could potentially delay delivery
schedules. This report shall be made available by the 5th
business day of each month.
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3.9 Upon written request from AorTech, Novoste B.V. will provide
an inventory deposit which will be applied against the
material cost incurred by AorTech to purchase all materials
required to support two (2) months of the Product forecast.
AorTech will typically order all material at a rate which will
compensate for shrinkage / yield losses. This rate may from
time to time be adjusted by Novoste B.V. provided such change
is delivered to AorTech in writing.
3.10 During the performance of this manufacturing Agreement,
AorTech will in accordance with Clause 3.4 purchase materials
to support Novoste B.V. requirements. Novoste B.V. shall
reimburse Aortech on request for the cost of all such
materials. Certain materials which AorTech will acquire will
be subject to minimum-buy requirements and quantity price
breaks which may result in excess material accumulation which
will be the responsibility of Novoste B.V. provided Novoste
B.V. has approved such purchases. Additionally, design changes
may cause materials to become obsolete. Obsolete materials due
to a design change will be returned to suppliers when
possible. Non-returnable inventory will be charged and
delivered to Novoste B.V..
a. During the performance of this manufacturing Agreement,
AorTech will provide Novoste B.V. with periodic updates
of the status and amounts of excess or obsolete material
held by Aortech.
b. AorTech will use its best effort to minimize the impact
of excess material and/or obsolete materials. AorTech
will return materials to suppliers for credit, less
restocking fees, when appropriate. However, final costs
associated with the accumulation of excess and obsolete
materials are chargeable and payable by Novoste B.V..
Any excess or obsolete inventories will be charged to
Novoste B.V. by AorTech at cost, without profit.
Disposition of excess or obsolete materials will be
coordinated with Novoste B.V. to minimize the impact of
cost to Novoste B.V. where possible. Novoste B.V.'s
targeted maximum budget is for obsolete material is
$15,000.
3.11 Novoste B.V. shall reimburse Aortech on request for all costs
incurred by Aortech on behalf of Novoste B.V. in carrying out
its duties under this Agreement
4.0 INSPECTIONS
4.1 All facilities used by AorTech for the manufacture of the
Product shall be open to inspection by Novoste B.V. or any
governmental, local or other regulatory agency or authority,
providing that AorTech receives reasonable written notice.
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4.2 AorTech shall immediately notify Novoste B.V. upon receipt of
communication scheduling an inspection, excluding an
inspection requested by Novoste B.V., stated above in Section
4.1.
5.0 BUSINESS REVIEWS
5.1 AorTech and Novoste B.V. shall, each at their own expense,
meet periodically to review performance and business
transacted, and to identify and resolve those issues which
have arisen since the last business review meeting. These
meetings shall be held at minimum of four (4) times per year.
6.0 PAYMENTS TO MANUFACTURER (AORTECH)
6.1 The initial price to be paid by Novoste B.V. to AorTech shall
be calculated at the rate of $18 (United States currency) per
hour (each such hour being referred to herein as a Direct
Labor Assembly Hour) in respect of each hour or part of an
hour which an AorTech employee shall devote to performing any
of the following activities: manufacture of Novoste B.V.
Product; inspection and testing of Novoste B.V. Product or
materials used to build Novoste B.V. Product; packaging of
Novoste B.V. Product; handling of material, sub assemblies and
/ or Novoste B.V. Product, shipping of Novoste B.V. Product,
and receiving of materials used to build Novoste B.V. Product.
AorTech will invoice Novoste B.V. monthly, at the end of each
month, for payment of the cost associated with performing
these activities in support of this Agreement. Novoste B.V.
will pay such invoices within thirty days of their being
issued by AorTech. Overtime shall be defined as the number of
hours worked beyond the normal work week. Overtime shall be
invoiced at the base rate of $18 per hour plus 50%, (over time
premium) (or $9) or $27 per hour.
6.2 AorTech shall, in good faith, maintain written records (time
sheets) for each individual assigned to work on Novoste B.V.
Product, whereby the number of hours worked, date work was
performed, and name of individual performing the work shall be
recorded. These records, as they apply to Novoste B.V.
Product, shall be made available to Novoste B.V. for review
upon request.
6.3 The price specified in clause 6.1 shall be increased annually
with effect from the anniversary of the last date of execution
hereof (a) in proportion to the increase (if any) in the
Retail Prices Index published in the United Kingdom by the
Department of Employment (or by any Government Department upon
which its duties in connection with such Index shall have
devolved) for the immediately preceding month of over that for
the same month in
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the preceding year, or (b) by 5% per annum, whichever shall be
the higher.
6.4 Novoste B.V. shall in addition to the price specified in
clause 6.1 pay to AorTech an overhead fee of $48 (United
States currency) (together with all Value Added Tax payable
thereon) in respect of each hour or part of an hour devoted by
an AorTech employee to providing management services, (each
hour being referred to herein as an Indirect Labor Hour) as
follows:
a. handling, disposition and resolution of routine
non-conforming materials and Product;
b. engineering support in the areas of quality assurance and
manufacturing as required to support ongoing Production
including troubleshooting of routine process and Product
issues as they arise in day to day Production;
c. source and procurement of all materials required to build
Novoste B.V. Product per the specifications stated in
this Agreement;
d. management support provided by AorTech's operation
Manager, Quality Assurance Manager and Warehouse
supervisor.
6.5 Novoste B.V. shall pay AorTech $5,000 (United States currency)
per month for use of a class 100,000 cleanroom dedicated
exclusively to manufacture the Product. In addition, the
following services shall be included:
a. the storage of materials within AorTech's warehouses
area; this shall include up to 500 square feet of
storage space. Novoste B.V. shall pay for any
additional storage space exceeding this 500 square feet
at a rate to be specified by AorTech and agreed upon
by Novoste B.V.;
b. passing materials for sterilization and coordinating all
sterilization scheduling at a Novoste B.V. approved
sterilization facility;
c. providing quarantine and quality assurance assistance for
finished Products;
d. receiving orders, allocating and packaging Products and
preparing shipping documents;
e. arranging collection with a freight forwarder;
f. controlling and tracing the foregoing services;
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g. monthly reporting to Novoste B.V. of all raw material
inventory, finished goods inventory and receipt and
dispatch of said material;
h. the provision of warehouse and Production control
personnel and inspection and quality assurance
management.
6.6 Novoste B.V. shall reimburse AorTech in respect of any capital
expenditure necessarily incurred by AorTech with the prior
Agreement of Novoste B.V., such Agreement not to be
unreasonably withheld for the purpose of assembling the
Product pursuant to this Agreement, including, without
prejudice to the foregoing generality, any expenditure
incurred in connection with the provision of new or additional
cleanroom facilities. This amount shall not exceed $10,000 US
dollars unless otherwise agreed by both parties in writing in
advance.
6.7 Novoste B.V. shall also pay to AorTech a fee of $30 US
dollars, (together with all Value Added Tax payable thereon)
in respect of each hour or part of an hour devoted by
AorTech's senior technician. Overtime shall be defined as the
number of hours worked beyond the normal work week. Overtime
shall be invoiced at the base rate of $30 per hour plus 50%,
(over time premium) (or $15) or $45 per hour.
6.8 Novoste B.V. shall pay AorTech a fifteen percent (15%) fee
based on the actual cost of materials purchased by AorTech,
where such materials are exclusiverly used to build Novoste
Product per this agreement (fee is equal to 15% of actual
material costs). This incremental material cost shall cover
any administrative, finance or other costs incurred by AorTech
to purchase materials required to build Novoste Product per
this agreement. This incremental material cost shall be
invoiced on a separate line item from that of actual material
cost.
7.0 DELIVERY, LEAD TIME AND FLEXABILITY
7.1 AorTech shall arrange delivery of the Product to such
destination as Novoste B.V. may designate in accordance with
Clause 7.4. All freight costs relating to delivery of Product
from AorTech's premises to their ultimate destination will be
at the expense of Novoste B.V. and will be reimbursed by
Novoste B.V. to AorTech within 30 days of a request for
payment in writing by AorTech to Novoste B.V.. Novoste B.V.
retains the right to approve the freight forwarder recommend
by AorTech.
7.2 Novoste B.V. will provide AorTech with a purchase order which
shall state the Product part number, quantities and date
required. AorTech shall use its best efforts to supplying the
Product in accordance with Novoste B.V. required ship dates.
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7.3 Novoste B.V. shall pay for all transportation costs and any
Value Added Tax as assigned in accordance with the terms in
Clause 7.1. All transit insurance costs in respect of onward
delivery of finished goods to Novoste B.V.'s customers, will
be the passed on to Novoste B.V. by AorTech.
7.4 Novoste B.V. may require that shipments of Product under this
Agreement be shipped by AorTech directly to Novoste B.V.
customers. These shipment locations will be specified by
Novoste B.V..
7.5 During the initial pre-Production stage (defined as the stage
where equipment installation, Product qualification, process
validation take place, and initial shelf stock units are
built), AorTech and Novoste B.V. shall work together to
develop a price per unit cost which includes the cost,
facility overhead, direct and indirect labor, and
sterilization costs. Upon developing a mutually agreed upon
price per unit, this manufacturing Agreement will be amended
to reflect such terms. Until such time pricing shall remain as
indicated in section 6 of this Agreement.
8.0 TERM
8.1 Subject to prior termination as provided in Section 9.1 below,
the initial term of this Agreement shall be from the date of
execution of this agreement until March 31st, 2000.
8.2 After the initial term of this Agreement, the duration of this
Agreement shall thereafter automatically renew for an
additional twelve month period except that either Novoste B.V.
or AorTech may terminate the Agreement by giving ninety (90)
days prior written notice of termination, such termination to
be effective at the end of the relevant twelve month period.
AorTech will complete the manufacture of any Products ordered
by Novoste B.V. up to the termination date.
9.0 TERMINATION
9.1 Notwithstanding the term set forth in Section 8.1 above, this
Agreement may be terminated prior to the expiration of the
initial term (or any renewal term) as follows:
a. AorTech shall have the option of terminating this
Agreement immediately if Novoste B.V. fails to pay any
amounts due and payable to AorTech in terms of this
Agreement which remain due and unpaid for thirty (30)
days after receiving written notices from AorTech that
such amounts were unpaid, due and owing to AorTech.
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b. Should either party commit any material breach of this
Agreement and fail to remedy the same within thirty (30)
days after receipt of written notice to do so, the party
giving notice shall by entitled forthwith to terminate
this Agreement by a notice in writing, without prejudice
to any claim for any damages or other relief arising out
of such breach, and any waiver of any breach shall not be
taken to a waiver of any subsequent breach.
c. In case of the bankruptcy, appointment of a trustee,
receiver of liquidator, assignment for the benefit of
creditors or insolvency of either party, or in the event
that either party liquidates its business, this
Agreement shall terminate immediately.
9.2 Upon termination of this Agreement, all amounts due and owing
from Novoste B.V. to AorTech, notwithstanding prior terms of
sale or Agreement, become immediately due and payable. All
tooling, equipment, inventory and documents shall be forwarded
by AorTech to a destination specified by Novoste B.V.. All
costs associated with the transfer of equipment,
documentation, records or other Novoste B.V. assets shall be
expensed to Novoste B.V..
9.3 With reference to Section 13 of this Agreement, if any of the
conditions listed in Section 13 of this Agreement should
occur, and the result of such condition represents a breach of
this Agreement, this Agreement will terminate.
10.0 CONFIDENTIAL INFORMATION AND ADVERTISING
10.1 AorTech and Novoste B.V. shall each maintain as confidential,
and not to disclose to third parties or use for its own
benefit, any specifications, drawings, blueprints, flow
charts, reports, data, business information, trade secrets,
manufacturing processes, or other confidential information of
the other party which AorTech or Novoste B.V., as the case may
be, learns or acquires by virtue of this Agreement, except
that AorTech or Novoste B.V. may disclose confidential
information pursuant to the order or requirement of a court,
administrative agency, or other governmental body, and for
disclosures required to be made by Novoste B.V. or its parent,
Novoste Corporation, pursuant to United States Securities Law.
AorTech and Novoste B.V. must notify the other party in
writing of the need for such disclosure in advance of any such
disclosure being made and AorTech and Novoste B.V. further
agree to use reasonable efforts to protect the confidential
information against disclosure to unauthorized persons.
10.2 AorTech may disclose confidential information to AorTech's
employees who have a need to know and legal duty to protect
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such confidential information. At Novoste B.V.'s written
request, AorTech agrees to destroy or otherwise dispose of all
confidential information, except as prohibited by regulatory
or safety agencies.
10.3 Without Novoste B.V.'s written consent, AorTech shall not in
any manner disclose (except as required for financing),
advertise, nor publish the existence of this Agreement nor the
terms of transactions under this Agreement, which shall be
considered as part of the confidential information.
10.4 The term confidential information shall not include
information which is in the public domain at the time of
disclosure or afterward, except where such information becomes
public due to a breach by the disclosing party of its
obligations hereunder, nor shall the term confidential
information in possession at the time of disclosure or which
may be disclosed by third party having the right to disclose
the same.
11.0 INSURANCE
11.1 Novoste B.V. shall provide AorTech, on or before execution of
this Agreement with evidence acceptable to AorTech from a
reputable insurance company certifying that Novoste has one or
more policies issued by such insurance company in respect of
Product liability insurance in respect of the Product in an
amount equivalent to at least EIGHT MILLLION U.S. DOLLARS ($8
Million).
11.2 AorTech shall provide to Novoste B.V., on or before execution
of this Agreement with evidence acceptable to Novoste B.V.
from a reputable insurance company certifying that AorTech has
one or more policies issued by such insurance company in
respect of Product liability, fire insurance, and theft
(catastrophic loss). In the event of a catastrophic loss, said
insurance must cover the cost of replacing all Novoste
equipment and fixtures at replacement value, Novoste purchased
supplies and components, Novoste B.V. finished Products.
Novoste equipment shall be covered by AorTech up to ONE
MILLION U.S. DOLLARS ($1 Million) Or other sum to be agreed
upon in writing.
12.0 INDEMNITES
12.1 Novoste B.V. shall at all times indemnify and hold AorTech
(and its respective directors, officers, employees and agents)
harmless and upon request will defend the same against all
actions, proceedings, claims, demands, losses, suits, outlays,
damages, judgments, penalties or expenses of any kind or
nature (including reasonable legal fees, other costs and
amounts paid in settlement
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with Novoste B.V.'s consent) which may be suffered or incurred
by any of them arising out of any defect in any Product or any
part thereof ;
12.2 AorTech shall at all times indemnify and hold Novoste B.V.
(and its respective directors, officers, employees and agents)
harmless and upon request will defend the same against all
actions, proceedings, claims, demands, losses, suits, outlays,
damages, judgments, penalties or expenses of any kind or
nature (including reasonable legal fees, other costs and
amounts paid in settlement with AorTech's consent) which may
be suffered by any of them arising out of any failure by
AorTech to exercise reasonable care in carrying out the tasks
specified in 1.2 of this Agreement.
12.3 Each party shall give the other party prompt notice of any
claim or suit relating to the subject matter of the
indemnities granted in terms of this Clause 12. At the
discretion of Novoste B.V., Novoste B.V. will assume the
defense of any claim, demand or action against AorTech,
however if shall upon written request by AorTech allow AorTech
to participate in the defense thereof, such participation to
be at the expense of AorTech.
13.0 DEFAULT
13.1 No failure or omission by either of the parties hereto in the
performance of any obligation contained in this Agreement
shall be deemed a breach hereof to the extent the same shall
result from any cause beyond the control of such party,
including, but not restricted to, acts of God, acts of local
governments or any agency thereof, requests of any
governmental authority or any officer, department, agency or
instrumentality thereof, fire, storm, flood, earthquake,
explosion, accident, acts of the public enemy, war, rebellion,
insurrection, riot, sabotage, epidemic, quarantine,
restrictions, strike, lock-out, dispute with workmen, labor
shortages, transportation embargoes, or failures or delays in
the delivery of any transportation facility, Product or
material necessary to the performance hereof.
14.0 COMPLIANCE WITH LAW
14.1 The illegality or unenforceability of any provision this
Agreement shall not impair the legality or enforceability of
any other provision.
15.0 NOTICES
15.1 Any notices required or permitted to be given pursuant to this
Agreement shall be sufficient if delivered either by personal
delivery or by registered post. Notices sent by post shall be
addressed as follows:
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If to Novoste B.V.: Novoste B.V.
Dillenburgstraat 11a
5652 AM Eindhoven
The Netherlands
Attn: David Gill
And one copy to Novoste
B.V. parent company,
Novoste Corporation
4350-C International Blvd.
Norcross, GA 30093
Attn: Donald Webber
If to AorTech: AorTech Europe Limited
Strathclyde Business Park
Bellshill
Strathclyde
Scotland ML4 3NJ
Attn: Richie Brown
Subject to change by written notice in accordance with this
paragraph.
15.2 Notices delivered personally shall be deemed to be received as
of the date of actual receipt; notices sent by post shall be
deemed to be received on the fifth business day after the date
of posting.
16.0 DESCRIPTIVE HEADINGS
16.1 The descriptive headings herein are inserted for convenience
of reference only and are not intended to be a part of or to
affect the meaning or interpretation of this Agreement.
17.0 ARBITRATION
17.1 In the event of any question or dispute or difference arising
between the parties as to the true intent and meaning of this
Agreement or the fair interpretation or the implement thereof,
the same shall be referred to the Dean for the time being of
the Royal Faculty of Procurators in Glasgow, whom failing an
Arbiter to be appointed by him as sole Arbiter, and the award
of such Arbiter, partial, interim or final, shall be binding
on the parties, who agree to exclude the jurisdiction of the
court to give its opinion on any question of law arising in
any such arbitration under in terms of Section 3 (1) of the
Administration of Justice (Scotland) Act 1972.
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18.0 GOVERNING LAW
18.1 This Agreement shall be governed by and construed in
accordance with the provisions of Scots Law.
19.0 MAINTENANCE OF CERTIFICATE
19.1 AorTech shall update its Quality Manual and inform the
regulatory body TUV of its desire to broaden the scope of
their ISO 9001 coverage to include contract-manufacturing
services within 45 days of entering into this contract.
19.2 AorTech will within six (6) months of entering into this
contract, deliver to Novoste B.V., a copy of the AorTech's
amended ISO 9001 certificate as confirmation that 19.1 above
has been met.
19.3 AorTech shall immediately inform Novoste B.V. of any
non-compliance or observation raised by the Company (AorTech)
or Notified Body (TUV Product Service) that may affect the
Product. This shall be done in writing within 3 business days
upon being issued the observation.
19.4 If AorTech shall lose its ISO 9001 certificate due to
unsatisfactory resolution of observations of non-compliance
issued by AorTech's notified body, or, AorTech changes
notified bodies, or, AorTech is unable to broaden its Quality
Manual as per 19.1 of this Agreement, Novoste B.V. will have
the option to terminate this contract, on thirty days written
notice.
19.5 AorTech shall maintain a cleanroom certification at class
10,000 status. Appropriate records verifying this
classification is maintained shall be made available to
Novoste B.V. upon request.
20.0 NO CHANGE
20.1 AorTech agrees to make no changes to either the facility,
process layout, process flow, Product, processes
(manufacturing, testing, sterilization and inspection),
Products intended end use, design, component, tooling,
packaging, labeling, instructions for use, or any change which
can or may effect the form, fit, function, safety or efficacy
of the device, end user, patient or Production operator,
without the express written permission of Novoste B.V.. The
person(s) designated by Novoste B.V. for approving any change
shall be Donald J. Webber, Director of Manufacturing
Operations, or Daniel Currie, Director of Quality Assurance,
unless otherwise amended in writing.
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21.0 NO IMPLIED LICENSE
21.1 The parties understand that, except as may be otherwise
expressly stated herein, neither the Terms or Conditions of
this Agreement, nor the acts of either party arising out of
this Agreement or related to Novoste B.V.s's purchase, use,
sale, or other distribution of Product may be considered in
any way as a grant of any license whatsoever under any of
Novoste B.V.'s or its parent, Novoste Corporation, present or
future patents, copyrights, trademarks, trade secrets, or
other proprietary rights, nor is any such license granted by
implication, estoppel, or otherwise.
22.0 OWNERSHIP
22.1 Specifications - AorTech acknowledges that the specifications
and all related writings, drawing, artwork, computer assisted
designs and similar works are and shall be the exclusive
property of Novoste B.V., or its parent , Novoste Corporation
(jointly "Novoste"), and Novoste retains all right, title and
interest, including copyright, relating to such material. Upon
termination of this Agreement for any reason with the
exception of breach by Novoste B.V., AorTech agrees to return
to Novoste B.V. all copies of the specifications and related
materials within ten (10) business days of such termination.
This material shall be complete in every respect, as to permit
experienced manufacturer to manufacture, assemble, test,
package and sterilize the Product described in this Agreement.
In the event of Breach by Novoste B.V., AorTech will return
all documentation within ten (10) days of resolution of any
outstanding technical issues and payment of outstanding
engineering or Production invoices.
22.2 Novoste Equipment - AorTech shall assist in the initial
installation, qualification, validation of Novoste equipment,
tooling, and fixtures, and maintain and account Novoste
equipment at the AorTech facility or AorTech's
sub-contractor's facility. AorTech hereby acknowledges that
Novoste equipment is the sole and exclusive property of
Novoste. Novoste shall provide identification and ownership
tags (also called asset tags) for all Novoste. equipment, and
AorTech shall ensure that such tags are properly placed and
maintained on all Novoste equipment. AorTech hereby covenants
that, during the term of this Agreement
a. AorTech and any sub-contractor of AorTech using
Novoste equipment shall utilize Novoste equipment
solely for manufacturing Novoste B.V. requirements of
the Product provided hereunder,
b. AorTech shall not encumber any of Novoste equipment,
nor shall AorTech permit Novoste equipment to become
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encumbered as a result of any act or omission of
AorTech or a subcontractor of AorTech.
c. AorTech agrees that it will not sub-contract the
manufacturing of Novoste B.V. Product without written
permission from Novoste B.V..
22.3 Within ten (10) business days following termination (with the
exception of termination due to breach by Novoste B.V.) or
expiration of this Agreement, AorTech agrees to properly pack
and return to Novoste, or cause to be properly packed and
returned to Novoste, F.O.B. point of shipment, all Novoste
equipment, the same to be shipped to such facility as Novoste
B.V. directs at Novoste B.V.'s expense.
22.4 AorTech acknowledges that any improvement made to any Novoste
equipment, tooling, fixture, process or system made by AorTech
where such service is paid by Novoste B.V., Novoste B.V. shall
own all rights and claims to such improvements.
23.0 WARRANTY
23.1 Limited Warranty: AorTech warrants to Novoste B.V., for the
shelf life of the Product as defined by Novoste
specifications, which shall be a minimum of twenty four months
from the date of sterilization, and a maximum of thirty-six
months from the date of sterilization, that all Product shall
be free from defects in material and workmanship, and shall
conform to applicable specifications, drawings, samples and
descriptions referred to in this Agreement.
23.2 AorTech shall rework or replace all defective Product
(typically within 15 days of receipt) unless otherwise
specified by Novoste B.V., at no cost to Novoste B.V.. All
rework of finished Product must be approved in writing before
starting any such rework by the Novoste B.V., Director of
Quality Assurance.
23.3 AorTech warrants its right under this Agreement to convey the
Product and that the Product is and will continue to be, upon
delivery from AorTech, free of all liens and encumbrances.
24.0 TRANSFERABILITY
24.1 AorTech acknowledges that Novoste Corporation is in the
process of forming its European corporate striucture, which
ultimately may include subsidiaries in several countries in
addition to Novoste B.V. in the Netherlands. Novoste B.V.
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reserves the right to assign or transfer this contract to
another subsidiary of the Novoste corporate group.
25.0 PREVIOUS AGREEMENTS
25.1 The contract signed by Novoste Corporation and AorTech Ltd. on
July 16th, 1998 is now agreed as terminated and that this
contract supercedes all other discussions or agreements in
relation to the subject matter of the contract.
IN WITNESS WHEREOF, the authorized representatives of the parties have
executed this Agreement under seal and date(s) set forth below:
AorTech Europe Limited Novoste B.V.
Contractor Buyer
/s/ Eddie McDaid /s/ David Gill
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Eddie McDaid David Gill
Managing Director General Manager
Date: Date: 12/23/98