Exhibit 10.6
Confidential Materials omitted and filed separately with the
Securities and Exchange Commission. Asterisks denote
omissions.
SUPPLY AND DISTRIBUTION AGREEMENT
This Agreement, dated as of
February 1, 2001 (the “Effective Date”), is
between Kawasumi Laboratories, Inc., a Japanese corporation with
its offices at 3-28-15, Minami-Ohi, Shinagawa-ku, Tokyo 140-8555,
Japan (“KL”) and Medisystems Corporation, a Washington
corporation with its offices at 701 Pike Street, 16 th Floor, Seattle,
Washington 98101, U.S.A (“MDS”). For purposes of this
Agreement, KL and its subsidiaries shall be referred as
“KL” and MDS and its subsidiaries shall be referred to
as “MDS”. Reference should be made to Article 25
of this Agreement for definitions of capitalized terms used
herein.
In consideration of the mutual
promises made herein and other good and valuable consideration, the
receipt of which is hereby acknowledged, the parties hereto agree
as follows:
ARTICLE 1
BACKGROUND
1.1 KL manufactures disposable
medical products and MDS sells and markets the Products (as defined
in Section 2.1) in the Territory (as described in Annex
B).
1.2 MDS manufactures disposable
medical products and MDS sells bloodlines (“BTL”),
fistula needles (“AVF”), needles, sets for subcutaneous
access devices (“VN”) and tube/bags sets for NxStage
equipment (“NX”) used in artificial kidney dialysis, as
well as pheresis needles for pheresis (“PHE”) and other
products. MDS also manufactures or purchases and sells components,
some of which (“Components”) are designed by MDS to be
used in the Products. Such Components will be sold or consigned to
KL for incorporation into the Products in accordance with this
Agreement, and under some conditions, certain Components may be
used or resold by KL for its own products or markets.
1.3 Pursuant to long-standing
business relations, agreements and understandings, the Products KL
sells to MDS are manufactured by KL to the MDS design
specifications and the KL process specifications. It has been
KL’s right and practice to delegate certain responsibilities
to its subsidiary, Kawasumi Laboratories (Thailand) Co., Ltd. and
KL may continue to so delegate. Such delegation shall not relieve
KL of its responsibilities to assure each provision of this
Agreement is complied with in full.
1.4 MDS and KL desire to continue
their relationship and to document in this Agreement the terms of
their cooperation.
1.5 In pursuance of this cooperation
and in compliance with certain requirements of the U.S. Federal
Food and Drug Administration (“FDA”), the parties have
entered into a Quality Assurance Agreement, dated as of
October 25, 1999 (the “QA Agreement”) which
governs certain aspects of the design and manufacturing of the
Products and the supply of Components.
1
ARTICLE 2
SPECIFICATIONS
2.1 The Products, Codes and
Components that are a subject of this Agreement are listed in Annex
A hereto, and shall meet the specifications set forth in the QA
Agreement and in accordance with the warranty set forth in
Section 10.1, as such specifications may, in accordance with
the terms of the QA Agreement, be amended or modified from time to
time (the “Specifications”) with trade names and/or
trademarks of MDS or others as set forth in the QA Agreement and
are hereafter referred to individually as “Codes” and
collectively as “Products”, or “Components”
respectively.
2.2 MDS shall provide KL with
necessary materials for packaging and labeling of the Products such
as artwork, negative films and so on.
ARTICLE 3
PURCHASES AND SHIPMENTS
3.1 Subject to the terms and
conditions of this Agreement, KL shall manufacture the Products, in
quantities up to KL’s Supply Commitment, and all in
accordance with the provisions of the QA Agreement, the
Specifications and the KL process specifications, and shall sell
the Products to MDS. MDS shall purchase the Products solely for
resale in the Territory, provided that MDS, if it sources VN or NX
from KL, may sell VN or NX anywhere in the World. MDS shall not
purchase BTL, AVF or PHE or sub-assemblies thereof from any other
third party other than KL except as provided in this Agreement. MDS
shall not sell the Products (other than VN and/or NX) directly or
indirectly to distributors or end-users for use or resale outside
of the Territory without KL’s prior written consent. KL shall
not sell BTL, AVF, VN, NX or PHE or sub-assemblies thereof directly
or indirectly for use or resale in the United States of America
without MDS’s prior written consent.
3.2 Prior to the commencement of the
twelve-month period commencing on February 1, 2001 and [**]
months prior to each subsequent such twelve-month period (such
initial period and each such subsequent period being hereinafter
referred to as a “Contract Year”), KL and MDS shall
discuss the purchase goals MDS hopes to achieve during the
subsequent Contract Year based on MDS’s forecast of market
conditions for such year (the “Goals”). The Goals for
the first Contract Year are incorporated into Annex D. During the
Term of this Agreement, as such Term may be renewed or extended
from time to time, and subject to the other terms and conditions
contained herein, MDS hereby agrees to purchase from KL an annual
quantity of Products at least equal to [**]% of the Goals for BTL
and [**]% of the Goals for AVF and PHE, such amount being
hereinafter referred to as MDS’ “Purchase
Commitment” for each such Contract Year and KL agrees to sell
to MDS an annual quantity of Products up to at least equal to [**]%
of the Goals, such amount being hereinafter referred to as
KL’s “Supply Commitment” for each such Contract
Year. If the parties cannot agree on new Goals [**] months prior to
each new Contract Year, this Agreement shall terminate at the
conclusion of such new Contract Year, provided, however, that if
MDS offers to accept Goals for each new Contract Year equal at
least to [**]% of the Goals for the then current Contract Year,
this Agreement shall be renewed for the new Contract Year with
Goals that equal those of the then current Contract Year. In the
event MDS makes no such offer and the parties cannot otherwise
agree on new Goals for the new
2
Contract
Year, then, during the new Contract Year the Purchase Commitment
and the Supply Commitment shall be reduced to [**]% of the quantity
of the prior Contract Year and this Agreement shall terminate upon
the conclusion of such new Contract Year.
3.3 In order to facilitate the
orderly forecasting of needs and the ordering, manufacturing and
shipping of Products, the parties agree to follow the following
procedures:
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a. |
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On or prior to the [**] day of each month (“Forecast
Date”) during the Term of this Agreement, MDS shall provide
KL with the following: |
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1. |
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a forecast (the “First MDS Forecast”) of MDS orders
to be placed [**] days from the Forecast Date; |
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2. |
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a revised forecast of MDS orders to be placed [**] days from
the Forecast Date; |
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3. |
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a further revised forecast (the “Final MDS
Forecast”) of MDS orders to be placed by the [**] day of the
subsequent month; |
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b. |
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Based on the Final MDS Forecast the previous month, on or prior
to the [**] day of each month during the Term of this Agreement,
MDS shall provide KL with a firm shipment order (a “Shipment
Order”) relating to the Purchase Commitment for the Codes MDS
desires to be delivered on a date not earlier than [**] and not
later than [**] days after the (i) date such Shipment Order is
placed or (ii) the [**] day of such month, whichever is later
(the “Shipment Period”). |
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c. |
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Based on the foregoing, KL shall purchase or produce components
(including the Components) necessary to manufacture and deliver the
Products during the Shipment Period. On or prior to the Forecast
Date during the Term of this Agreement, KL shall provide MDS with
the foregoing: |
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1. |
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a forecast (the “First KL Forecast”) of KL orders
for Components to be place [**] days from the Forecast Date; |
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2. |
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a revised forecast of KL orders to be place [**] days from the
Forecast Date; |
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3. |
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a further revised forecast (the “Final KL
Forecast”) of KL orders to be placed by the [**] day of the
subsequent month; |
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d. |
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Based on the Final KL Forecast the previous month, on or prior
to the [**] day of each month during the Term of this Agreement, KL
shall provide MDS with a firm shipment order (a “Shipment
Order”) for the Components KL desires to be shipped on a date
not earlier than [**] and not later than [**] days after the
(i) date such Shipment Order is placed or |
3
(ii) the
[**] day of such month, whichever is later (the “Shipment
Period”).
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The parties recognize that some components (such as
packaging/labeling) may become unusable if not incorporated into
Products within a finite period of time (“Dead Stock”).
Accordingly, if KL produces or purchases components based on the
First MDS Forecast and such components are not, because Shipment
Orders are less than the First MDS Forecast, timely incorporated in
sold Products and become Dead Stock, KL shall invoice MDS and MDS
shall pay KL for the cost of such Dead Stock. If KL does not ship a
Shipment Order during the applicable Shipment Period, and such
failure is not excused by an event described in Section 3.5,
KL shall ship such Shipment Order as soon as possible, by
airfreight at KL’s sole expense, if so requested by MDS. KL
and MDS shall discuss and exchange additional forecasting and
production scheduling information in order to minimize variances in
KL’s production and MDS’s inventories throughout each
Contract Year. The total quantity of Products in MDS’s
Shipment Orders shall approximately equal the total quantity of
Products in the relevant Final MDS Forecast unless a variance has
been accepted by KL. Similarly, the total quantity of Components in
KL’s Shipment Orders shall approximately equal the total
quantity of Components in the relevant Final KL Forecast unless a
variance has been accepted by MDS. KL may at its discretion supply
Products to MDS in an amount exceeding its Supply Commitment during
any Contract Year, but will have no obligation thereof under this
Agreement. |
3.4 All sales of Products to MDS
under this Agreement shall be subject to the provisions of this
Agreement and shall not be subject to the terms and conditions
contained in any Purchase Commitment or Shipment Order of MDS, or
confirmation or invoice of KL, except insofar as any such Purchase
Commitment, Shipment Order, confirmation or invoice establishes
(a) the quantity of Codes committed to and ordered for
shipment, and (b) the quantity of Codes to be delivered at
each location (the “Locations”).
3.5 KL assumes no liability and shall
not be liable to MDS for any failure to fill or delay in filling
Shipment Orders received from MDS to the extent of any cause beyond
the control of or occurring without the fault of KL including but
not limited to strikes, lockouts (but only if resulting from worker
sabotage, vandalism or similar action), floods, fires, accidents,
delays in the delivery of raw materials, parts or completed
merchandise by the supplier thereof. For the purposes of this
Section 3.5, FDA actions caused by the fault of KL are deemed
to be within the control of KL. In the event of any delay caused by
any of the foregoing, KL shall use reasonable commercial efforts to
fulfill MDS’s orders in a timely fashion. KL shall notify MDS
if it anticipates any potential delay in the filling of any of
MDS’s Shipment Orders caused by any of the foregoing.
3.6 MDS assumes no liability and
shall not be liable to KL for any failure to place Shipment Orders,
deliver Components or to fulfill any Purchase Commitment to the
extent of any cause beyond the control of or occurring without the
fault of MDS including but not limited to strikes, lockouts (but
only if resulting from worker sabotage, vandalism or similar
action) floods, fires, accidents, delays in the delivery of raw
materials, parts or competed merchandise
4
by the
supplier thereof. In the event of any delay caused by any of the
above, MDS shall use reasonable commercial efforts to fulfill
KL’s Component orders and/or to place Shipment Orders in a
timely fashion. MDS shall notify KL if it anticipates any potential
delay in the filling of any KL Component order or in placing
Shipment Orders caused by any of the foregoing.
3.7 Notwithstanding Sections 3.2
and 3.3, MDS may be relieved of its obligations with respect to any
specific Shipment Order to Purchase Commitment in whole or in part,
at MDS’s option, should KL be in material breach of this
Agreement and if such breach is uncured within [**] days after KL
receives notice from MDS of such breach, or should a delay under
Section 3.5 occur and if such delay is uncured within [**]
days after MDS receives notice from KL of such delay.
3.8 Notwithstanding Sections 3.2
and 3.3 KL may be relieved of its obligations with respect to any
specific Shipment Order or Supply Commitment in whole or in part,
at KL’s option, should MDS be in material breach of this
Agreement and if such breach is uncured within [**] days after MDS
receives notice from KL of such breach, or should a delay under
Section 3.6 occur and if such delay is uncured within [**]
days after KL receives notice from MDS of such delay.
3.9 MDS shall maintain and keep MDS
inventories of the Products in accordance with then applicable
Purchase Commitment and the Final MDS Forecast provided in
Section 3.3.
3.10 MDS shall submit to KL each
calendar quarter a report about the market situation of the
Products in the Territory including the tendency of the market,
activities of third parties and other remarkable changes in the
market.
ARTICLE 4
SHIPMENT OF THE PRODUCTS/COMPONENTS
4.1 KL will ship the Products
properly ordered in accordance with Article 3 to the Locations
at the prices listed in Annex A. MDS will ship the Components to
the Location and at the prices listed in Annex A.
4.2 KL shall prepare and send by
facsimile to MDS a packing list, invoice and bill of lading for
each shipment of the Products. KL shall notify MDS if any shipment
will not be made within the Shipment Period applicable to an MDS
Shipment Order. MDS shall prepare and send to KL a packing list,
invoice and bill of lading for each shipment of the
Components.
ARTICLE 5
PRICES
5.1 Except as otherwise specified
herein, KL will sell the Products to MDS and MDS agrees to purchase
the Products from KL, and MDS will sell the Components to KL and KL
agrees to purchase the Components from MDS.
5.2 It is expressly agreed that the
prices for the Products and Components are listed in Annex A and
include the cost of transportation and insurance to the Locations
specified in the applicable MDS Shipment Order. However, it is also
expressly agreed that MDS may order, and
5
if so
ordered KL shall sell the Products FOB Bangkok. If MDS requests
airfreight, and KL is not obliged to pay for such airfreight under
the provisions of Section 3.3, 10.2, or 14.2, KL shall invoice
MDS at the FOB Bangkok prices listed in Annex A, and MDS shall pay
the airfreight. If KL is obliged to pay the airfreight under the
provisions of Section 3.3, 10.2, or 14.2, KL shall pay such
airfreight and invoice MDS at the Location prices applicable to the
actual destination of such shipment.
ARTICLE 6
PAYMENT
6.1 The terms of payment for the
Products purchased by MDS and for the Components purchased by KL
under this Agreement shall be D/A (Documents against Acceptance) at
[**] days from KL’s or MDS’s bill of lading date.
With respect to this Section 6.1, each party shall send all
necessary documents for payment to the other party within
[**] days from KL’s or MDS’s bill of lading date.
Any amounts not paid within [**] days of the bill of lading
date shall be subject to a service charge until paid equal to the
lesser of [**] percent ([**]%) per month or the maximum rate
allowed by law. If full payment is not received by KL or MDS within
[**] days of KL’s or MDS’s bill of lading date,
MDS or KL respectively shall be considered to be in material breach
of this Agreement and subject to the provisions of Section
12.1.
6.2 During the Term of this
Agreement, Medisystems Corporation shall provide [**] to KL a
letter substantially in the form of Annex C hereto, signed by the
firm of public accountants that audit Medisystems
Corporation’s books of account.
ARTICLE 7
MDS SUPPLIED COMPONENTS; PRODUCT CHANGES
7.1 During the Term of this
Agreement, MDS will sell and/or consign to KL the Components to be
incorporated by KL, in accordance with its then current process
specifications, into the Products. Except as expressly provided in
Annex B or agreed by the parties, KL shall not incorporate any
Components into any other product nor resell any of the Components
for sale or resale by any third party.
7.2 KL shall maintain and keep KL
inventories of the Components in accordance with the First MDS
Forecast provided by MDS in accordance with Section 3.3, but
shall not produce or purchase components with respect to any
prospective Shipment Order prior to receiving the First MDS
Forecast in respect to such prospective Shipment Order.
7.3 During the Term of this
Agreement, MDS may require new BTL or AVF Product designs to meet
the competitive requirements of its market and/or to meet its
Purchase Commitment. MDS may design new Components, Codes and
Products and cause changes to be made to the Specifications, in
accordance with the provisions of the QA Agreement. KL will have
the right, in good faith to reject such new Specifications based
only on lack of capacity to produce such new Specifications. And,
in any event, KL will have the right to adjust the price for
Products based on such changed Specifications only to the extent
that such changes increase or decrease KL’s true cost of
production. KL will cooperate with MDS in incorporating such
6
new
Components, Codes and Products and changes into the Specifications
for the Products. To assist KL in production planning, MDS will
meet at least [**] yearly with KL for the purpose of describing any
current MDS design projects that, within the succeeding twelve
months, are likely to produce a change in the Specifications and
the introduction of new Components for the Products. During the
Term of this Agreement, KL may make changes in its process
specifications and/or components supplied by KL, all in accordance
with the provisions of the QA Agreement. At least [**] yearly, KL
shall advise MDS, in accordance with Section 5.3 of the QA
Agreement, of any prospective KL process changes that, within the
succeeding twelve months, are likely to produce a change in
KL’s process specifications and/or of the components supplied
by KL or to affect the quality of the Products.
7.4 Whenever MDS adds a new
Specifications for Components or Products, KL has a first right
(prior to that of any third party) to bid on the supply of such
Components. KL’s bid may be based on MDS’s design
and/or KL’s alternative design, if any, but the content of
the Specifications shall remain within the sole discretion of MDS.
KL and MDS may negotiate which party shall supply such Components
by taking into consideration cost, quality, quantity and patent
issues. Nothing herein shall imply any license or obligation to
license the patents of one party to the other and no license shall
be granted unless the parties mutually so agree in a separate
license agreement.
7.5 At reasonable intervals, KL may,
with prior notice to and with the prior consent of MDS which
consent shall not unreasonably be withheld, send its
representatives to MDS to audit the procedures or processes used in
manufacturing the Components. At reasonable intervals, MDS may with
prior notice to and with the prior consent of KL which consent
shall not unreasonably be withheld send its representatives
(including representatives of its customers) to KL to audit the
procedures or processes used in manufacturing the Products.
ARTICLE 8
REGULATORY RESPONSIBILITY
8.1 KL shall be responsible, at its
expense, for complying with all of its obligations under the
provisions of the QA Agreement. Failure to manufacture the Products
in compliance with the QA Agreement shall be considered a breach of
this Agreement by KL as to which MDS’s exclusive remedies
shall be to terminate this Agreement under Section 12.1, to
terminate any specified Shipment Order(s) under Section 3.7
and/or to reduce its outstanding Shipment Orders, any such
termination or reduction to be credited on a unit basis toward the
applicable Purchase Commitment.
8.2 MDS shall be responsible, at its
expense, for complying with all of its obligations under the
provisions of the QA Agreement relating to the design, sale or use
of the Products, including but not limited to obtaining
authorization under Section 510(k) of the United States Federal
Food, Drug and Cosmetic Act, as amended (the
“Act”).
8.3 Except as provided in this
Agreement, MDS shall not use any trade name, trademark or logo
owned or controlled by KL, or any trademark, trade name or logo
confusingly similar therewith, during or after the Term of this
Agreement. KL shall not use any trade name,
7
trademark or logo of MDS, or any trade name, trademark or logo
confusingly similar therewith, without obtaining MDS’s prior
written permission during or after the Term of this
Agreement.
ARTICLE 9
GUARANTEE
9.1 All Products sold to MDS under
this Agreement are hereby guaranteed by KL, as of the time the
title to the Products is transferred to MDS, to be not adulterated
or misbranded within the meaning of the Act, and not an article
which may not, under the provisions of Section 510(i) of the Act,
be introduced into interstate commerce. If KL breaches this
guarantee with respect to any lot of Product, MDS may immediately
return to KL, at KL’s expense, any Products of such lot
received by MDS. At MDS’s option, KL either will credit MDS
for such Products, or pay to MDS any monies paid by MDS for the
Products that breach this guarantee. If KL breaches this guarantee,
then to the extent that MDS terminates or reduces Shipment Orders
to allow for replacement products, such termination or reduction
will be credited on a unit basis toward the applicable Purchase
Commitment. The foregoing, along with Article 14, represents
MDS’s sole and exclusive remedy for a KL breach of this
guarantee. In no event will KL be deemed to be in breach of this
guarantee to the extent KL’s failure to meet the guarantee is
caused by KL’s adherence to the Specifications, proper use of
the Components or compliance with MDS instructions regarding the
Specifications or the Components. Notwithstanding the foregoing, KL
shall in all events manufacture the Products in accordance with the
KL process specifications.
ARTICLE 10
WARRANTY
10.1 KL warrants the Products sold to
MDS under this Agreement are, as of the time title is transferred
to MDS, in compliance with the Specifications and the QA Agreement
and made in accordance with the then applicable KL process
specifications. KL warrants that its parts and process
specifications are reasonably appropriate for the production of
Products which insofar was they relate solely to said parts and
process specifications (and not in any way related to the
Specifications and/or the Components supplied by MDS to KL in
connection with the production of the Products) are merchantable
and fit for resale in the Territory (subject to the
end-users’ proper usage thereof and assuming that the
Products are used in connection with their intended purpose, e.g.,
for use in artificial kidney dialysis). MDS warrants that the
Components sold to KL under this Agreement are, as of the time
title is transferred to KL, in compliance with the Specifications
and the QA Agreement and further the Components are reasonably
appropriate for the production of the Products which insofar as
they relate solely to said Components and the Specifications (and
not in any way related to the process specifications and any parts
supplied by KL in connection with the production of the Products)
are merchantable and fit for resale in the Territory (subject to
the end-users’ proper usage thereof and assuming that the
Products are used in connection with their intended purpose, e.g.,
for use in artificial kidney dialysis).
10.2 MDS acknowledges and agrees
that, except for the provisions of Section 10.3, KL’s
sole responsibility to MDS in the case of breach of the foregoing
warranty shall be for KL, by mutual agreement of MDS and KL, to
repair or replace the Products with respect to which such warranty
is breached, or at MDS’s election for KL to return to MDS all
payments made by
8
MDS to
KL with respect to such Products or to credit MDS in the amount of
all payments made by MDS to KL with respect to such Products. In no
event shall KL be liable for MDS’s loss of profits, loss of
use, or incidental, consequential or special damages of any kind
even if KL has been advised by MDS of any possibility
thereof.
10.3 KL hereby indemnifies and agrees
to hold MDS harmless from and against all claims, liability,
damage, cost or expense of MDS, including its reasonable
attorney’s fees paid to third parties arising out of, or in
connection with, or as a result of, to the extent based upon the
failure of any of the Products to meet the warranty set forth in
Section 10.1 at the time of delivery to MDS and such failure
is not due to any failure of a Component to meet the
Specifications, provided MDS promptly notifies KL of any such
claim, KL has control over the defense of such claim and MDS
provides reasonable cooperation. In order to discharge KL’s
obligations under this Section 10.3, KL and MDS agree that MDS
shall obtain and keep in force during the Term of this Agreement,
product liability insurance with a limit of liability for the
Territory of not less than US$20 million, and shall name KL as
an additional insured. KL shall reimburse MDS for the cost of such
insurance at the rate of US$3.66 per US$1,000 of MDS purchases from
KL.
10.4 MDS shall indemnify and hold KL
harmless from and against all claims, liability, damage, cost or
expense of KL, including its reasonable attorney’s fees to
the extent based upon: (a) any false or misleading product
claims, representations, descriptions or other statements, whether
oral or written, made or alleged to be made by MDS or its
representatives in any advertising, publicity, promotion or sale of
any of the Products, and (b) any product claim arising out of,
based on, or caused by negligent handling of the Products by
MDS.
10.5 The KL warranties set forth
herein (including without limitation the warranty set forth in
Section 10.1 that the Products sold to MDS under this
Agreement are, as of the time title is transferred to MDS, in
compliance with KL’s then applicable process specifications)
are exclusive and in lieu of all other warranties, whether express
or implied, including the implied warranties of merchantability,
infringement, and fitness for a particular purpose. The MDS
warranties set forth herein are exclusive and in lieu of all other
warranties, whether express or implied, including the implied
warranties of merchantability, infringement, and fitness for a
particular purpose.
ARTICLE 11
TERM OF AGREEMENT
11.1 The term (“Term”) of
this Agreement shall be for the seven (7) year period
beginning on the Effective Date of this Agreement, provided that
such Term shall automatically be renewed for subsequent periods of
three (3) years unless either party gives notice of
termination not less than one (1) year prior to the date on
which this Agreement would otherwise terminate.
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ARTICLE 12
TERMINATION
12.1 Either party may terminate this
Agreement for any material breach of it by the other party, by
giving ninety (90) days written notice to the other party, if
such breach shall, as of the expiration of [**] day period, remain
uncured.
12.2 Either party shall have the
right at its option to terminate this Agreement effective
immediately upon giving written notice to the other party in the
event of:
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a. |
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appointment of a trustee, receiver or other custodian for all
or substantially all of the property of such other party, or for
any lesser portion of such property if the result is materially and
adversely to affect the ability of such other party to fulfill its
affirmative or negative obligations hereunder; |
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b. |
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a judicial finding that such other party is insolvent or
bankrupt; |
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c. |
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the filing of a petition in bankruptcy for itself by such other
party or a decision that bankruptcy proceedings will be instituted
with respect to such other party based on a petition filed by a
third party; |
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d. |
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an assignment of a substantial part of the assets of such other
party for the benefit of creditors; |
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e. |
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an attachment of a substantial part of the assets of such other
party for the benefit of creditors; or |
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f. |
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the dissolution or liquidation of a party. |
12.3 If either party here suffers any
event of the type enumerated in Section 12.2, it shall
immediately notify the other party in writing of the occurrence of
such event.
ARTICLE 13
EFFECT OF TERMINATION
13.1 No termination of this
Agreement, other than by reason of breach of this Agreement by MDS
will relieve KL from its obligation to deliver all Products ordered
by any properly placed Shipment Order of MDS, nor will any
termination, other than by reason of breach of this Agreement by
KL, relieve MDS from accepting and paying for all Products ordered
by MDS under any properly placed Shipment Order issued by MDS or
relieve MDS of its obligations pursuant to Section 3.3. The
indemnification obligations under Article 10 shall survive the
termination of this Agreement.
ARTICLE 14
PRODUCT RECALL
14.1 In the event that it shall be
deemed necessary by KL or MDS to recall any of the Products sold by
MDS because the Products are believed to violate any provision of
any law, the
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guarantees provided in Section 9.1 or the warranties provided
in Section 10.1, and if such Products have already been
delivered to the Location, KL and MDS shall, subject to
Section 14.4 below, share equally all out-of-pocket costs and
expenses of such recall, including, without limitation, refunds to
customers for recalled Products but only in an amount not to exceed
the sum of the following items:
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a. |
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the purchase price paid by MDS to KL for the recalled
Products; |
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b. |
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the freight paid by MDS associated with the shipment of
affected Products from the Locations; |
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c. |
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the cost of notifying customers; |
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d. |
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the costs associated with the shipment of recalled Products
from customers to MDS; and |
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e. |
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the cost of shipping replacement Products to customers. |
MDS may immediately return any
recalled Products to KL for rework or credit.
14.2 If Products have been recalled
or placed under import detention by the FDA, MDS may place
replacement Shipment Orders with KL and KL shall ship such Products
by air shipment when required in MDS’s sole discretion, and
shall continue air shipments until the effects of such recall or
import detention have been completed or ended. To the extent MDS
requires substitute products for recalled or detained Products,
such substitutes will be credited on a unit basis toward the
applicable Purchase Commitment and MDS shall submit KL proof of its
substitutes from another supplier. In the event MDS or any of its
distributors are prevented from operating as a result of a recall
or FDA action MDS shall be relieved of its Purchase Commitment to
the extent such recall or FDA action prevents the resale of the
Products.
14.3 In the event of such a recall of
any of the Products sold by MDS, the parties will cooperate fully
with each other in effecting such recall.
14.4 In the event that KL or MDS
determines that it will recall any Products sold by either of them
because the Products are believed to violate any provision of any
law, the guarantees of Section 9.1 or the warranties provided
in Section 10.1, KL or MDS may, once the recall has been
substantially completed, request an arbitrator, appointed by the
American Arbitration Association, who shall determine whether
KL’s or MDS’s determination to recall was necessary and
reasonable. The arbitrator may require that KL or MDS bear all
costs, damages and expenses of such recall or may apportion such
costs and expenses between the parties as the arbitrator deems just
under all of the circumstances.
14.5 MDS shall bear all costs and
expenses of a recall or import detention of the Products caused by
the negligence of MDS. KL shall bear all costs and expenses of a
recall or import detention of the P
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