Exhibit 10.1
Confidential treatment has been requested for
portions of this exhibit. The copy filed herewith omits the
information subject to the confidentiality request. Omissions are
designated as [*]. A complete version of this exhibit has been
filed separately with the Securities and Exchange
Commission.
SUPPLY AGREEMENT
This Supply Agreement (hereinafter
referred to as the “Agreement”) is entered into this
7th day of March, 2005 (the “Effective Date”), by and
between Cambrex Bio Science Walkersville, Inc.
(“Seller”), with offices located at 8830 Biggs Ford
Rd., Walkersville, MD 21793, USA and Xcyte Therapies, Inc.
(“Buyer”), with offices located at 1124 Columbia
Street, Suite 130, Seattle, WA 98104.
Now, therefore, for good and
valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the parties agree as follows:
Seller agrees to sell and Buyer
agrees to purchase the materials specified in Exhibit A (the
“Materials”) under the terms and conditions of this
Agreement.
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2.
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Quality and
Warranties
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a.
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Seller shall
supply the Materials in accordance with the Quality Assurance
Agreement (the “QA Agreement”) signed by the parties
and in accordance with the specifications contained in Exhibit B,
which shall include a functional test for the Materials to be
performed by both parties that may be amended and/or updated from
time to time upon mutual agreement of the parties (the
“Functional Testing”), and any other specifications
which the parties may mutually agree to in writing (the
“Material Specifications”). Seller guarantees and
warrants that at the time of delivery of the Materials to the Buyer
designated delivery location, Materials shall comply with the
applicable Material Specifications, and any laws, regulations, or
statutes then applicable to the production of Materials, such as
but not limited to cGMP (current good manufacturing practice)
guidelines and ISO 9001 (2000).
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b.
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All Materials
purchased by Buyer shall, prior to shipment, be inspected, tested
and approved by Seller as satisfactory and meeting all applicable
Material Specifications. Seller shall provide to Buyer a
certification of analysis and/or conformance with each shipment
that verifies that the Material(s) meets all applicable Material
Specifications. Promptly after the Effective Date, Seller shall
confirm in writing with Buyer the validated lot size of the
Materials, and shall not change such lot size without the prior
written consent of Buyer. Seller shall promptly notify Buyer of any
discrepancies or nonconformance of raw materials known to Seller to
be used in the production of the Materials (including but not
limited to information relating to the operation of the aseptic
filling suite).
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c.
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Upon request
from Buyer, Seller shall fully cooperate in a site audit by any
representatives of Buyer to assess and ensure adequate quality
assurance systems in accordance with FDA’s Quality System
Regulations at 21 C.F.R. Part 820 and ISO 9001 (2000) in connection
with the Materials. Buyer shall provide reasonable advance notice
to Seller of such audit and conduct the audit during normal
business hours at mutually agreed upon times. Buyer shall limit
such audits to no more than once every 12 months unless Buyer
reasonably determines there are quality issues or discrepencies
that warrant additional audits. If Buyer observes a condition
during an audit which reasonably causes it to believe that the
Materials are not being manufactured in accordance with regulations
as set forth in FDA’s Quality System Regulations at 21 C.F.R.
Part 820, ISO 9001 (2000) or the Materials Specifications, Seller
shall address the concerns and provide necessary modifications
required to bring the facilities and production procedures into
such compliance.
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d.
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Should Buyer
request Seller to provide proof of production, such as the
certificate of analysis, of the Materials to a regulatory
authority, Seller shall reasonably cooperate and supply available
information in response to such request. Buyer shall reimburse any
direct and reasonable costs incurred by Seller in complying with
such request.
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e.
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Seller shall
use commercially reasonable efforts to notify Buyer in advance of
any supply shortage to allow Buyer enough time to identify an
alternate supplier, and, in the event that Seller is unable to
supply Materials to Buyer for more than a six month period, Seller
shall cooperate in good faith with Buyer and any such alternate
supplier to assist Buyer in securing an alternative means of
supply, provided that any such alternative supplier enters into a
confidentiality agreement with Seller upon terms and conditions
reasonably satisfactory to Seller. In the event Seller’s
primary manufacturing location becomes incapable of producing the
Materials, Seller will use commercially reasonable efforts to
produce the Materials in an alternative cGMP facility, with
Buyer’s prior written consent.
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f.
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THE WARRANTIES
IN THIS ARTICLE ARE EXCLUSIVE AND IN LIEU OF ALL OTHER WARRANTIES
WHETHER STATUTORY, EXPRESS OR IMPLIED (INCLUDING ALL WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR PARTICULAR PURPOSE AND ALL
WARRANTIES ARISING FROM COURSE OF DEALING OR USAGE OF
TRADE).
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3.
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Orders,
Forecasts and Price
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Buyer must submit a written purchase
order(s) (the “Purchase Order(s)”) to Seller for
Buyer’s requirements of Materials. Buyer acknowledges that
Seller’s typical manufacturing cycle time from the date of
receipt and acceptance of a Purchase Order is [*], meaning that
from the time the Purchase Order is received and
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[*]
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Certain
information on this page has been omitted and filed separately with
the Securities & Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.
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accepted by Seller, it will be a
minimum of [*] before the manufacture of the quantity of Materials
covered by a Purchase Order is complete. Any Purchase Order that
Buyer wishes to place with Seller shall be submitted by
post/regular mail, facsimile or any other mutually agreed upon
manner. Seller shall send its written confirmation of receipt of
each Purchase Order from Buyer within seven (7) days from the date
of receipt by Seller of the Purchase Order. If Buyer claims that no
such confirmation was received, and Seller is able to demonstrate
from its records that one was sent, then the Purchase Order(s)
shall be considered accepted. Seller’s failure to notify
Buyer of Seller’s rejection of a Purchase Order shall
constitute Seller’s acceptance of such Purchase Order. Each
Purchase Order submitted by Buyer must contain a proposed delivery
date. If Seller is unable to meet the proposed delivery date
contained in the Purchase Order, Seller will duly note such in its
confirmation of receipt of the Purchase Order, and Seller and Buyer
will agree on a new delivery date in writing. Each Party shall have
the right to require correction of obvious calculation and typing
errors in the Purchase Order(s).
The initial price of the Materials during the
term of this Agreement shall be as listed on Exhibit A. An increase
of [*] shall be permitted on January 1 of every other year during
the term of this Agreement, beginning January 1, 2006. If
Seller’s raw material costs associated with the supply of
Materials increase or decrease by more than [*] from the cost of
such raw materials as of the Effective Date (as substantiated by
Seller), and such change is due to reasons beyond the control of
both parties, a reasonable adjustment to account for such change
(downward or upward, as applicable) will be made to the Materials
price so long as such price is agreed upon by both parties in
writing as being reasonable based on the change in raw materials
costs.
In addition to the submission of
Purchase Orders, Buyer may, in its sole discretion and on a
quarterly basis, provide Seller with a [*] rolling forecast of
Buyer’s Materials requirements during the forthcoming [*]
period. Should Buyer wish to submit such forecasts, Seller shall
confirm each such forecast in writing within ten (10) business days
after receipt by Seller. If Seller is not able to confirm the total
quantity requirement as detailed in the forecast, Seller shall,
within the same ten (10) day time period, confirm the quantity that
it is able to confirm at that time and give Buyer an early warning
notice that it may be unable to meet the rest of the quantity
requirements. Seller agrees that any forecast provided by Buyer is
a non-binding estimate based on Buyer´s assumptions at the
time of submission of such forecast. However, if the quantity
requirements of a forecast, or any portion of the quantity
requirements, have been confirmed by Seller, the confirmed portion
of such forecast shall becomes binding [*] before the forecasted
delivery date for such quantity of Materials. All forecasts,
whether binding or non-binding, are subject to Buyer’s
submission of Purchase Orders.
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[*]
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Certain
information on this page has been omitted and filed separately with
the Securities & Exchange Commission. Confidential treatment
has been requested with respect to the omitted portions.
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3.4
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Cancellation of
Purchase Orders
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Due to the manufacturing cycle time
stated in Section 3.1, any cancellation of a Purchase Order by
Buyer, which is not based upon a material breach of the Seller,
must be made within 2 weeks of Seller’s receipt of such
Purchase Order. If a Purchase Order cancellation, which is not
based upon a material breach of the Seller, is received by Seller
outside of this timeframe, Buyer will be liable for the total
quantity of Materials covered by such Purchase Order, in accordance
with the pricing contained in Section 3.2.
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3.5
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Alternate
Manufacturing Facility
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An affiliate of Seller has an
alternate manufacturing location for the Materials at laboratories
and manufacturing plant located at Verviers, Belgium. In the event
Seller’s primary manufacturing location at Walkersville, MD
becomes incapable of manufacturing the Materials, Seller will use
commercially reasonable efforts to manufacture the Materials at
such Belgium facility but only with Buyer’s prior written
consent. The Walkersville, MD plant will continue to take
responsibility for regulatory and contractual compliance of product
manufactured in Belgium, unless otherwise requested by Buyer. If
Buyer elects to allow Seller to manufacture the Materials at such
Belgium facility, Seller acknowledges and agrees that Seller shall
be responsible for the shipping and importation costs to the extent
such costs are in excess of the shipping costs if such Materials
had been shipped from the Walkersville, MD facility to
Buyer.
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4.
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Shipment,
Delivery and Delivery Dates
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The price stated in Section 3.2 is
for delivery of Materials by truck. Delivery by any other means
will increase the price stated in Section 3.2. Shipment of the
Materials shall be CPT SEATTLE, WASHINGTON, USA (INCOTERMS 2000)
including packing. Delivery to any other destination designated by
Buyer may increase the price. The delivery date shall be the date
stated in the Purchase Order in accordance with Section 3.1, or
such other date as the parties may mutually agree to in
writing.
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5.
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Inspection
and Acceptance
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Buyer shall ha
