AMENDED AND RESTATED
SUPPLY AND DISTRIBUTION AGREEMENT
This Amended and Restated Supply and Distribution Agreement ("Restated
Agreement") is made with effect from December 1,1996, between Rochester Medical
Corporation, ▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇ ("Rochester") and
Euromedical Industries Sdn Bhd, with offices at ▇.▇, ▇▇▇ ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇,
▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ("EI").
Rochester and EI are parties to a Supply and Distribution Agreement
dated as effective April 14, 1994 (the "Original Agreement"); and
Rochester and EI desire to amend and restate their Original Agreement
in order, INTER ALIA, to eliminate EI's minimum purchase obligations, to
eliminate and phase out EI's exclusive distribution rights, to provide for
Rochester furnishing EI with packaged product for distribution by EI and
customers supplied by EI, to restrict Rochester from dealing directly with EI's
customers identified by this Restated Agreement, and for other purposes;
1. SUPPLY AND DISTRIBUTION OF PRODUCTS
1.1 Rochester agrees to supply EI and EI agrees to distribute the
Standard 100% Silicone ▇▇▇▇▇ Catheters described on Exhibit A
(the "Products"). As used herein, "Products" expressly
excludes Rochester's Antibacterial ▇▇▇▇▇ Catheter, its Comfort
Sleeve(R) ▇▇▇▇▇ Catheter, its Hand Actuated Retention Catheter
in both continuous drain and valved configurations, and any
other of its products not specifically identified on Exhibit
A.
1.2 The Products and their packaging ("Packaging") shall exactly
conform to the specifications agreed between EI and Rochester
(the "Specifications"). Any change to the Specifications shall
be subject to the written approval of both parties; provided,
however, that Rochester may include applicable patent numbers
on the Packaging upon issuance to Rochester of patents
covering the Products.
1.3 The Products shall be supplied in finished sterile form and
packaged in Packaging in accordance with the Specifications;
provided, however, that the parties acknowledge that EI may at
its options, from time to time, purchase unsterilized Products
packaged only in a clear inner liner, or may purchase the
Products in bulk, non-sterile, with or without a valve, upon
such terms and conditions as the parties may reasonably agree
in the future.
1.4 EI and Rochester expressly intend that Rochester shall furnish
EI with Product that is packaged for resale by EI under EI's
own brand and marks and shall also furnish EI with Product
that is packaged for resale by EI's customers under brands and
marks owned by such customers of EI, respectively. All such
packaging shall be in accordance with the Specifications.
1.5 From time to time during the term of this Restated Agreement,
EI may identify customers in addition to those presently
supplied by EI, and Rochester will supply Products for EI's
additional customers appropriately packaged in accordance with
the Specifications as reasonably agreed and amended from time
to time by EI and Rochester.
1.6 For each Contract Year (as subsequently defined) of this
Agreement. EI shall purchase from Rochester all of EI's
requirements of Products and shall give Rochester the first
right to manufacture any other silicone ▇▇▇▇▇ catheters;
provided, however, that EI may purchase Products or other
silicone ▇▇▇▇▇ catheters from a third party to the extent that
(i) Rochester is unable to fulfill all of EI's forecast
requirements of Products or silicone ▇▇▇▇▇ catheters within
the period covered by any forecast because of insufficient
manufacturing capacity, insufficient technical capability, or
inability to meet required quality standards, or (ii)
Rochester is unable to supply Products or silicone ▇▇▇▇▇
catheters meeting the specifications of new customers
identified by EI pursuant to Section 1.5. EI shall have no
obligation to purchase any minimum amount of Product from
Rochester during the term of this Restated Agreement.
2. TERRITORY; EXCLUSIVITY AND NON-COMPETITION
2.1 EI shall be Rochester's non-exclusive, worldwide distributor
for the Products in all countries.
2.2 Rochester shall not, for the term of this Restated Agreement,
either (i) directly supply Product or (ii) directly solicit
sales of Product to any customer of EI for whom Rochester
packages any Product. For purposes hereof, "directly" includes
any action taken by Rochester on its own behalf and excludes
any action taken by any distributor of Rochester's products
that is not owned or controlled by Rochester or under common
ownership or control with Rochester. For purposes hereof, "any
customer of EI" excludes former customers of EI who have
discontinued purchasing any Product for at least six (6)
continuous months.
3. PRICES, SHIPMENT AND PAYMENT TERMS
3.1 EI shall purchase the Products at the prices the parties shall
agree upon by separate writing. The prices so agreed shall
remain fixed through December 31, 1997. During the last
calendar quarter of 1997, and during the last calendar quarter
of 1998, the parties shall undertake good faith negotiations,
in light of then prevailing market conditions, regarding
pricing to be effective from January 1 until December 31 next
following. If the parties are unable to reach agreement by the
last day of December of any such calendar quarter, this
Restated Agreement shall terminate on the last day of June
next following.
3.2 Payment for Products purchased by EI shall be made by bank
transfer in US Dollars net, 60 days from the date of invoice.
3.3 All prices are quoted FOB Rochester's facility, Minnesota. EI
shall take title to and assume the Risk of loss of the
Products once they are loaded onto EI's nominated carrier at
such facility,
3.4 EI shall pay all normal freight charges, provided, however,
that Rochester shall ship Products by air freight when
necessary to meet its obligations under Section 4.2, or to
replace Products pursuant to Section 9 of this Restated
Agreement and in such cases shall bear pay the excess cost of
air freight over normal shipping charges.
3.5 The terms of this Restated Agreement shall have precedence
over any conflicting terms included in either party's standard
terms and conditions which may be attached to orders placed or
accepted under this Restated Agreement.
4. FORECASTING ORDERING AND MINIMUMS
4.1 On or before March 31, 1997 for the initial year, EI shall
prepare a non-binding forecast of EI's orders for Products to
be ordered through November 30, 1997; for each subsequent
year, EI shall prepare on or before October 31 of each year a
non-binding forecast of EI's orders for Products during the
twelve month period beginning December 1 through November 30
of the following year. The first nine-month period and each
subsequent twelve-month period shall be referred to as a
"Contract Year". This forecast shall be updated at least once
every ninety (90) days.
4.2 EI will place orders with Rochester from time to time in
amounts which are reasonably consistent with its forecast.
Rochester will acknowledge orders from EI within two working
days. Sterilized Products will be ready for pick up not more
than 60 days following receipt of order, and unsterilized
Products will be available for pick up not more than 45 days
following receipt of order. Rochester will advise EI
immediately of any back orders.
5. STOCK RECALLS
5.1 EI will maintain a sufficient stock of packaged Products to
meet anticipated market demand, including the requirements of
EI's customers who resell the Products under their own marks
and brands.
5.2 Rochester will repurchase from EI at the price paid by EI to
Rochester any Products which become obsolete, outdated or
unsaleable through any fault of Rochester. "Fault" does not
include new products which Rochester has or may develop;
provided, however, that Rochester shall have given EI
reasonable notice of Rochester's intention to market new
products that might compete with any of the Products. EI
expressly acknowledges having received notice of Rochester's
Antibacterial ▇▇▇▇▇ Catheter, its Comfort Sleeve(R) ▇▇▇▇▇
Catheter, and its Hand Actuated Retention Catheter in both
continuous drain and valved configurations.
5.3 In the event that Rochester or EI recalls any Products or
Products incorporating the Products sold or distributed by EI
solely because the Products are believed to be defective or to
violate any provision of applicable law, then (i) if the
defect or violation is due to any act or omission of
Rochester, then Rochester shall bear all costs and expenses of
such recall, including the cost of notifying customers and
costs associated with the shipment of recalled Product from
customers to Rochester or EI, or (ii) if the defect or
violation is due to any act or omission of EI, then EI shall
bear all costs and expenses of such recall, including the cost
of notifying customers and costs associated with the shipment
of recalled Product from customers to Rochester or EI,
6. REGULATORY RESPONSIBILITY
Rochester represents and warrants that it has obtained all necessary
approvals from the FDA or equivalent regulatory authority to sell the
Products in the USA and all other countries where Rochester has
existing business, including but not limited to compliance with the
requirements of the European Community Medical Device Directive. If EI
needs to obtain regulatory approval for itself to sell the Products in
any country, then Rochester shall cooperate with EI in obtaining such
approval.
7. MANUFACTURE AND QUALITY CONTROL
7.1 All Products shall meet the Specifications, shall be
manufactured in accordance with Good Manufacturing Practice
("GMP") for Medical Devices established by the United States
Food and Drug Administration as provided under 21 U.S.C.
3600)(f), and shall be subjected to quality control inspection
by Rochester in accordance with quality control standards
including without limitation process controls, as established
by Rochester and approved by EI.
7.2 EI shall have the right to review and approve Rochester's
production and quality control procedures, including without
limitation Rochester's internal assembly procedures and
procedures for testing subassemblies at different stages of
assembly, and Rochester's engineering, assembly and testing
documentation for the Products, and to visit Rochester's
facilities at reasonable times with a representative of
Rochester present in order to assure satisfaction of the
requirements of this Restated Agreement. EI shall be deemed to
approve Rochester's production and quality control procedures
complying with ISO 9001 and CM 4601.
7.3 Rochester will notify EI immediately of any inspection of its
facilities by a federal, state or local regulatory agency that
results in advice of noncompliance with GMP, CE ▇▇▇▇, or
similar regulatory requirements; will furnish EI with the
results of such inspection; and will furnish EI with advice of
corrective actions, and the results thereof, taken by
Rochester to achieve such compliance.
8. GUARANTY
Rochester guarantees that all Products sold to EI are, as of the date
of shipment or delivery, not adulterated or misbranded within the
meaning of the United States Federal Food, Drug and Cosmetics Act or
amendments thereto, and any similar federal, state or local laws or
regulations, and are not articles which may not, under the provisions
of such laws, be introduced into interstate commerce.
9. WARRANTIES, DEFECTS
9.1 Rochester warrants that the Products comply with the
Specifications.
9.2 Rochester warrants that the Products and their parts and their
Packaging are fit for their intended purpose and free from
defects due to design, materials or workmanship and that each
Product is identifiable to a particular hatch number.
9.3 Any Product that EI or a customer of EI finds to be
non-conforming or defective due to any fault of Rochester may
be returned to Rochester with a statement of the defect, and
Rochester shall repair or replace the Product free of charge
to EI. In addition, Rochester shall reimburse EI for labor or
travel costs that EI has incurred following authorization from
Rochester, which shall not be unreasonably withheld, to
investigate a claim of non-conformance or defect. Nothing in
this clause shall operate to exclude or restrict the liability
of Rochester for negligence causing death or personal injury.
9.4 ROCHESTER is generally knowledgeable with respect to the
patent rights of third parties relating to ▇▇▇▇▇ catheters,
and has conducted such inquiry and investigation, consisting
of a review of prior American and European art for purposes of
determining patentability, as it deemed reasonably necessary
for the purpose of determining whether the present or
presently intended manufacture, sale and/or use of the
Products infringes any patent or technology of any third
party. ROCHESTER has not been advised of any infringement upon
any patent or other intellectual property rights belonging to
any other person or entity caused by the present or presently
intended manufacture, sale and/or use of the Products. To the
best of Rochester's knowledge, based upon such inquiry and
investigation, the present or presently intended manufacture,
sale and/or use of the Products does not infringe any patent
or technology of any third party.
9.5 Rochester agrees to indemnify and hold EI harmless against any
losses, claims, damages or liabilities to third parties to
which EI may become subject insofar as such losses, claims,
damages or liabilities (or actions in respect thereof) arise
or are based upon a claim that EI's sale and/or use of the
Products infringe the patent rights of any third party.
Promptly after EI's receipt of notice of the commencement of
any action of or the intent to commence any action, EI will,
if a claim in respect thereof is to be made against Rochester,
notify Rochester in writing of the commencement thereof or of
the intent to commence an action, as the case may be, and
omission so to notify Rochester will relieve Rochester from
any liability hereunder as to the particular item for which
indemnification is then being sought. In case any such action
is brought against EI, and it notifies Rochester of the
commencement thereof, Rochester will be entitled to
participate therein and, to the extent that it may wish, to
assume the defense thereof, with counsel who shall be to the
reasonable satisfaction of EI, and after notice from Rochester
to EI of Rochester's election so to assume the defense
thereof, Rochester will not be liable to EI party under this
Statement of Indemnification Rights for any legal or other
expenses subsequently incurred by EI in connection with the
defense thereof. Rochester shall not be liable to EI on
account of any settlement of any claim or action effected
without the consent of Rochester. Rochester shall not be
liable to EI for any lost opportunity or consequential damages
due to EI's inability to sell the Products in any jurisdiction
in which EI's sale of the Products would infringe any patent
or intellectual property owned by any third party; provided,
however, that EI shall be entitled to return to Rochester all
inventory rendered unsalable as a result of such patent or
intellectual property infringement claim, or Rochester will
issue EI a credit for this inventory.
10. CONFIDENTIALITY
All technical and commercial information, data regarding processes and
know-how ("Confidential Information") disclosed by either EI or
Rochester to the other shall remain the property of the disclosing
party. The party receiving the Confidential Information shall keep all
Confidential Information as confidential and shall not use it for any
purpose other than as may be expressly permitted under this Restated
Agreement. Such receiving party shall not disclose such Confidential
Information except to such person who both (i) needs to know the
Confidential Information for a proper purpose under this Restated
Agreement and (ii) acknowledges in writing that the Confidential
Information may not be used or disclosed except in conformance with the
requirements of this Restated Agreement.
11. TRADEMARKS-PACKAGING
11.l Rochester shall package the Products in the Packaging in
accordance with the Specifications for sale by EI and EI's
customers, who shall have the right to sell the Products under
their own trademarks, brands and labels.
11.2 Rochester shall acquire no right or interest by reason of this
Restated Agreement in any trademarks or trade names used by EI
or by its customers in connection with the marketing or sale
of the Products; and shall be deemed by reason of this
Restated Agreement to have only such rights respecting such
trademarks and trade names as may be necessary to produce the
Packaging as set forth in the Specifications.
12. LIABILITY: INSURANCE
12.1 Rochester shall indemnify and hold EI harmless from any and
all damage or expense, including reasonable attorney's fees
and disbursements arising from acts and/or omissions of
Rochester or its agents including, but not limited to , any
and all claims arising from third parties in connection with
alleged negligence in the design or manufacture of the
Products or their parts or their Packaging, or in connection
with a breach of any of the warranties contained in Section 9,
Section 10, or Section 18.2 of this Restated Agreement.
12.2 EI shall hold Rochester harmless from any and all claims
arising from acts and/or omissions of EI including, without
limitation, any and all claims arising from third parties in
connection with alleged negligence in the distribution or sale
of the Products.
12.3 Rochester and EI warrant, respectively, that they each carry
product liability insurance for the Products being sold under
the Restated Agreement.
12.4 Neither party shall be liable to the other for any incidental
or consequential damages under this Restated Agreement.
13. TERM
This Restated Agreement shall remain in effect for an initial term
which shall end on November 30, 1999 (the "Initial Term") and
thereafter may be renewed on such terms as the parties may in good
faith agree.
14. TERMINATION
This Restated Agreement may be terminated at any time:
(a) by written notice from either party to the other in the event
of a breach by the other party of any of the terms of this
Restated Agreement, which breach shall not be remedied within
forty five (45) days from receipt of a written notice to that
effect, or
(b) by written notice from either party to the other in the event
of the insolvency of either party or its inability to pay its
debts in the ordinary course of business or the judicial
appointment of a liquidator, receiver or administrator.
(c) Upon prior written notice ("Termination Notice") given by
either party to the other no sooner that January 1, 1998,
which shall specify a date ("Termination Date") at least six
(6) months following the date such Termination Notice was
given, in which event this Restated Agreement shall terminate
on the Termination Date specified in the Termination Notice.
15. ASSIGNMENT
Any and all rights of either party under this Restated Agreement may be
assigned by such party to any company owned by or under common ultimate
ownership with such party upon written notification thereof to the
other, or, as part of the sale, transfer or assignment to a third party
of such party or of that portion of the business or assets of such
party that manufactures, adds value to or distributes the Products.
16. ENTIRE AGREEMENT; AMENDMENT; SAVINGS
This Restated Agreement constitutes the entire agreement between the
parties and may be amended only by written agreement of the parties.
This Restated Agreement supersedes the Original Agreement in its
entirety; provided, that all rights, obligations, duties and
liabilities of the parties, respectively, under the Original Agreement
shall be preserved to the extent necessary to enforce any executory or
monetary obligation of a party relating to Products sold and delivered
by Rochester to EI, or by EI to its customers, prior to the effective
date of this Restated Agreement
17. FORCE MAJEURE
Any delay or failure in the performance of any obligation under this
Restated Agreement by either party shall be excused if caused by
occurrences beyond such party's reasonable control.
18. GOVERNING LAW
18.1 This Restated Agreement shall be governed by the laws of the
State of Minnesota, excluding the Conflicts of Laws provisions
thereof.
18.2 Rochester represents (i) that it has the requisite experience
and expertise to provide the Products, parts and Packaging
under this Restated Agreement, and (ii) that its sale and
delivery of the Products under this Restated Agreement comply
in all material respects to all applicable legal and
regulatory requirements of the United States, the North
American Free Trade Agreement countries, the European Common
Market, the European Free Trade Association and of Japan,
including but not limited to compliance with export control
laws. Rochester represents that it will use its best efforts
to take all necessary measures, including obtaining any
required permits, licenses or approvals, including export
licenses.
18.3 The Parties agree to attempt to settle any claim, controversy
or dispute in connection with, arising out of or relating to
this Restated Agreement or the performance, enforcement,
breach, termination, application or validity hereof (herein,
"Controversy") through good faith negotiations in the spirit
of mutual cooperation. If those attempts fail, the Controversy
will be mediated by a mutually acceptable mediator to be
chosen by the parties within 45 days after written notice by
the Party demanding mediation. Neither party may unreasonably
withhold consent of the selection of the mediator and the
parties will share the costs of mediation equally, The parties
may agree to replace mediation with some form of Alternative
Dispute resolution (ADR). such as neutral fact-finding or a
mini-trial. Any Controversy which cannot be resolved by the
parties through mediation or another form of ADR within six
months of the date of the initial written demand for mediation
may then, and only then, be submitted for arbitration. Any
Controversy that is not settled by mediation as hereinbefor
provided shall be submitted to arbitration. Such arbitration
proceedings shall be held in Minneapolis, Minnesota, in
accordance with the Minnesota Uniform Arbitration Act, with
each party appointing one arbitrator and the two arbitrators
thus chosen appointing a third, neutral arbitrator, who shall
be appointed by the court upon application of either party if
the two chosen arbitrators fail to agree on a third, neutral
arbitrator. The arbitrators shall furnish the parties with a
written decision setting forth findings of fact, conclusions
of law and an order; and (ii) a stenographic record shall be
made of the arbitration proceedings. In addition to any
monetary award that may be given, the arbitrators may order or
direct either party to do any act required of it by this
Restated Agreement or to refrain from the doing of any act or
practice that is contrary to this Restated Agreement. This
agreement to arbitrate shall be specifically enforceable. Each
party shall bear its own costs and expense in any such
proceedings, but the arbitrators may, in their discretion and
consistent with this Restated Agreement, award costs and
attorneys' fees to either or both of the parties.
19. NOTICES
All notices required under this Restated Agreement shall be delivered
by hand, by courier, or by registered post to the addressee at its
address mentioned above, to the attention of the President.
Executed by:
ROCHESTER EI
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
--------------------------------- --------------------------------
Title: President Title: Product Manager
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Date: March 18, 1997 Date: March 19, 1997
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ATTACHMENTS
Exhibits to Attach
A. PRODUCTS
Exhibit A
Rochester
Description French Size Balloon Size Part Number
----------- ----------- ------------ -----------
2-Way Standard Pediatric 6 1.5cc 1-4206
8 3cc 1-4208
10 3cc 1-4210
2-Way Standard 12 5cc 1-4212
14 5cc 1-4214
16 5cc 1-4216
18 5cc 1-4218
20 5cc 1-4220
22 5cc 1-4222
24 5cc 1-4224
2-Way Standard 16 30cc 2-4216
18 30cc 2-4218
20 30cc 2-4220
22 30cc 2-4222
24 30cc 2-4224
26 30cc 2-4226
3-Way Standard 18 5cc 3-4518
20 5cc 3-4520
22 5cc 3-4522
24 5cc 3-4524
26 5cc 3-4526
3-Way Standard 18 30cc 3-4318
20 30cc 3-4320
22 30cc 3-4322
24 30cc 3-4324
26 30 3-4326
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