Exhibit 10.9
CONTRACT MANUFACTURING AGREEMENT
This Contract Manufacturing Agreement ("Agreement") is made as of February 28, 2001 (the "Effective Date") between Peak Industries, Inc., 4300 Road 18, Longmont, CO 80504 ("Peak") and Aksys, Ltd., Two Marriott Drive, Lincolnshire, IL 60069 ("Aksys").
AGREEMENT
In consideration of the mutual covenants, promises, and conditions set forth below, the parties, intending to be bound, agree as follows:
1) Supply Obligations. During the Term, (a) Peak shall manufacture the
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Products in accordance with the terms and conditions set forth in this
Agreement and the Specifications, and (b) Peak shall manufacture all of
Aksys's requirements for Products as provided in Section 5 (a) except
as provided below in Section 5(b).
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2) Design and Specifications.
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a) Specifications. The "Specifications" shall mean all of the
following: (i) the preliminary drawings and specifications for
the Products will be mutually agreed upon and controlled in
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the Peak Manufacturing and Quality System (PMQS), and all
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revisions thereof delivered in writing by Aksys to Peak and
accepted by Peak; (ii) manufacturing procedures and quality
plans for the specific assembly in accordance with Section
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2(c); and (iii) all prototypes made by Peak and approved by
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Aksys for production.
b) Design Changes. Peak and Aksys will mutually review and accept
changes in Specifications by releasing such changes in the
PMQS. Peak reserves the right to re-quote prices in the
event of Aksys changes to the Specifications.
c) Testing and Quality. Aksys and Peak will establish testing
procedures mutually agreed upon by Peak and Aksys. Peak will
evaluate and incorporate Aksys test procedures into its PMQS.
Aksys and Peak will agree on Non Recurring Engineering fees to
compensate appropriate activities. Peak agrees that Aksys's
representatives may have access to the area of Peak's facility
where Products are being manufactured or stored or where parts
and materials are being processed or stored at all times
during normal business hours for purposes of quality
inspection and verification of manufacturing procedures to
Specifications.
d) Quality Requirements.
i) Aksys shall maintain the "Design History File" and perform all
necessary "Design Verification and Validation."
ii) Aksys shall be responsible for identifying any components
requiring lot traceability. These requirements will be
released into the PMQS as a customer specification.
iii)Peak shall maintain an approved vendor list (AVL) which shall
serve as a record of acceptable suppliers. Any suppliers
selected, evaluated and approved by Aksys or their
representative shall be noted as a customer approved supplier
on the AVL. All suppliers selected by Peak shall be either
approved or certified according to the PMQS.
iv) Peak will perform process validation where results cannot be
verified by subsequent inspection or test. Any additional
validation will be specified by Aksys. Aksys will provide
specifications for and will obtain any necessary regulatory
approvals of printed materials, including labels manuals,
artwork and copy.
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v) Aksys will investigate and handle complaints from end-users.
Peak shall cooperate with Aksys's investigations, including
providing manufacturing-related records as they relate to the
investigation. Aksys will reimburse Peak for all reasonable
costs and expenses in cooperation of such investigation.
vi) Aksys is responsible for conducting product recalls. Peak
shall cooperate with Aksys recall investigations, including
providing manufacturing-related records as they relate to the
recall. Peak and Aksys shall cooperate in jointly assessing
the root cause of a product recall. Both parties will mutually
agree as to the assessment of responsibility. Should Aksys be
determined solely responsible for the recall, Aksys will
reimburse Peak for all reasonable costs and expenses in
cooperation of such recall. Should Peak be determined solely
responsible, Aksys will not reimburse Peak for expenses
incurred in providing replacement components. Aksys will bear
the cost of all field service related activities.
vii)Aksys is responsible for all installation and start up
activities of the Product.
3) Tools and Fixtures. Aksys shall be responsible for purchasing all
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tooling and fixtures that are required for production of the Products
(including any tooling and fixtures required due to a change to the
Specifications) and which Peak does not own as of the Effective Date.
All such tooling and fixtures shall be held by Peak in trust for
Aksys's exclusive use in accordance with manufacturing and testing
procedures established for Aksys's products only. Such tooling and
fixtures shall be owned by Aksys and identified to Peak's lenders,
creditors, shareholders and other third parties as Aksys assets
consigned to Peak. Except for normal production maintenance, which will
be the responsibility of Peak, Aksys shall be exclusively responsible
for the costs to repair or replace such tooling and fixtures. Peak and
Aksys shall cooperate to obtain the best available pricing for all such
tooling and fixtures. Peak agrees to execute and deliver to Aksys upon
request a form UCC-1 or such other documents as Aksys reasonably may
request to protect its interest in such assets.
4) Forecasts.
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a) Generally. Aksys agrees to provide Peak a six (6) month
rolling forecast of Aksys's reasonably anticipated cumulative
quantity of the Product for such six-month period. Aksys
agrees to update the forecast monthly and provide it to Peak
each month. Peak is authorized to purchase materials for the
first thirteen weeks of the forecast (the "Rolling 13 Week
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Firm Forecast") after the product has officially been launched
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into the marketplace. Pre-launch purchasing quantities will be
provided by Aksys.
b) Long Lead Time Items. Peak may request from Aksys written
authorization to purchase certain long lead time items for
Peak inventory, safety-stock and manufacturing requirements
("Special Inventory"). Upon termination or cancellation of
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this Agreement, Aksys shall purchase from Peak, at Peak's
actual cost, any unused Special Inventory not to exceed the
amount that has been specifically agreed to in writing by
Aksys.
C) Deposit. Aksys agrees to provide a one-time cash deposit in an
amount equal to Peak's cost for the materials required to
produce the number of Product units specified in the initial
Rolling 13 Week Firm Forecast. Such deposit shall be applied
as a credit against each subsequent invoice. No deposit shall
be required for any order other than the initial deposit
described herein.
5) Orders and Fulfillment.
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a) Purchase Order. Aksys shall issue written purchase order
releases (PO releases) for its Product requirements. Peak
shall accept and fulfill all such PO releases to the extent
that the Product quantity ordered by Aksys for delivery in
any one week period does not exceed the delivery forecast
for such week in the Rolling 13 Week Firm Forecast provided
by Aksys at least [thirteen (13) weeks] prior to
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such week; provided, however, that Peak shall make all
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reasonable efforts and afford first priority to production
for Aksys to accept and fulfill PO releases that exceed such
forecasts. Aksys shall provide a required delivery date for
each PO release based on a thirty (30) day lead time or as
otherwise mutually agreed between Aksys and Peak.
b) Exclusivity; Inability to Supply. During the Term and for so
long as Peak continues to timely supply Aksys' requirements
for the Products, Aksys shall not have the Products made by
any third party; provided, however, that nothing in this
Agreement shall be deemed to preclude Aksys from
manufacturing the Products itself. Peak shall provide
immediate written notice to Aksys if Peak reasonably
anticipates that it may be unable to meet Aksys'
requirements specified in the then-current Rolling 13 Week
Firm Forecast (or thereafter), and in such event Aksys shall
be entitled to have Products made by other third parties,
and may thereafter allocate, in Aksys's sole discretion, its
Product requirements among Peak and such third parties.
Exclusivity is predicated upon Peak's maintenance of ISO
9002 certification and FDA registration during the term of
the agreement. Loss of either of these certifications will
result in forfeiture of exclusivity until certification is
reestablished.
c) Order Cancellation. Aksys may cancel any PO release or any
Rolling 13 Week Firm Forecast, provided that in such event,
Aksys shall pay Peak for Products and any inventory affected
by the cancellation as follows, not to exceed to purchase
price for such order: (i) 100% of Peak's price to Aksys for
all finished Products in Peak's possession, (ii) 110 % of
the cost of all inventory in Peak's possession procured for
Aksys confirmed purchase orders and not returnable to the
vendor or usable for other customers, whether in raw form or
work in process, (iii) 100% of the cost of inventory on
order and not cancelable, (iv) any vendor cancellation
charges incurred with respect to inventory accepted for
cancellation or return by the vendor, and (v) actual costs
to Peak of labor incurred by Peak related to work in process
for Aksys' s canceled PO releases. Upon such payment all
such inventory and work in progress shall become the sole
property of Aksys.
d) Order Changes. Peak will make commercially reasonable efforts
to accommodate changes to Aksys confirmed purchase orders.
Peak will move out purchase order dates to accommodate
changes, but in no event will the move out exceed thirty (30)
days. Purchase orders moved out greater than 30 days may be
invoiced at full value upon completion.
e) Part Change Orders. Aksys agrees to purchase from Peak, at
Peak's actual cost, any inventory purchased by Peak in
reliance on Aksys's Rolling 13 Week Firm Forecast, which
inventory is rendered obsolete due to a change to the
Specifications. Peak shall, however, first use reasonable
efforts to return any such inventory, and Aksys agrees to pay
for the restocking charges and shipping if applicable.
6) Packaging, Shipping and Delivery. Peak shall ship the Products in
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accordance with packaging and shipping instructions provided by Aksys.
Unless otherwise specified in writing in a particular PO release, all
Product deliveries shall be shipped F.O.B. factory to the destination
specified by Aksys for delivery, and Peak shall insure such shipments
against any loss or damage to the goods caused during shipment.
7) Payment.
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a) Invoice. Peak will invoice at the time of shipment of
Products. Payment is due at Peak on or within twenty (20)
calendar days from the date that such invoice is received by
Aksys.
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b) Pricing. Peak's invoices shall reflect charges for the
Products as specified in Exhibit B. Such charges are exclusive
of taxes, shipping and insurance. Charges for taxes, shipping
and insurance (to the extent applicable) shall be separately
stated on Peak's invoice.
c) Cost Reductions. Peak agrees to seek ways to reduce the cost
of manufacturing Products by obtaining alternate sources of
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