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EXHIBIT 10.27
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REDACTED VERSION
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CLINICAL MANUFACTURE AND SUPPLY AGREEMENT
THIS AGREEMENT (the "Agreement") is entered into on January 25, 2001 by
and between ABC Laboratories, Inc., of Columbia, Missouri ("ABC") and NeoRx
Corporation, of Seattle, Washington ("NeoRx"). The Agreement becomes effective
on January 15, 2001 and supercedes the Clinical Manufacture and Supply Agreement
between ABC and NeoRx dated September 1, 2000.
WITNESSETH
WHEREAS, ABC desires to manufacture (166)Ho-DOTMP at the
radiopharmaceutical manufacturing facility located in rooms 111, 222, 232 and
232B at Missouri University Research Reactor ("XXXX") in Columbia, Missouri (the
"Facility"); and
WHEREAS, NeoRx desires that ABC manufacture and supply to and on behalf of
NeoRx, and ABC is willing to manufacture and supply, certain quantities of [*]
((166)Ho-DOTMP) (the "Product") for NeoRx's use in clinical trials, all in
accordance with the terms and conditions set forth in this Agreement;
[*] DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT
TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE
COMMISSION.
NOW THEREFORE, in consideration of the foregoing promises and agreements
set forth herein, the parties agree as follows:
AGREEMENT
I. SCOPE OF WORK
(A) Processing Responsibilities. ABC will (1) manufacture, analyze,
package in dosage form, and inspect and label (collectively "Process") Product
at the Facility in accordance with cGMP and the Product specifications set forth
on Exhibit A (which is incorporated herein by this reference), unless NeoRx
Quality Assurance approves (on a per batch basis) in writing any deviation in
batch test result(s) from Product specifications; (2) maintain records regarding
the Product in conformity with cGMP; and (3) supply the Product to NeoRx in such
doses as NeoRx may order from ABC in accordance with this Agreement. NeoRx
acknowledges that ABC can Process Product only as permitted by XXXX Health
Physics ("HP"). Furthermore, NeoRx acknowledges that in order to perform the
process, ABC must [*].
(B) QA/QC Release Testing. ABC will perform all QA/QC release testing on
each batch of Product as required pursuant to cGMP and the Product
specifications set forth on Exhibit A.
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(C) Procurement Responsibilities. ABC will procure, test, release, and
maintain sufficient inventory of raw materials, manufacturing and QC components
and reagents necessary to Process the Product in accordance with this Agreement,
other than (1) DOTMP supplied by NeoRx and (2) (166)HoCl(3) supplied by XXXX. If
ABC is unable to procure certain raw materials, it may request NeoRx to provide
assistance with the procurement of certain other raw materials.
(D) Record Keeping and Access. ABC will make available to NeoRx and any
applicable governmental agency all records relating to the Process and Facility
as they relate to the Product.
(E) Facility Access and Inspection. ABC will permit NeoRx and FDA
inspectors to access and inspect the Facility (as permitted by XXXX HP) to
ensure that the Product is being Processed in accordance with cGMP and the
Product specifications as set forth on Exhibit A.
(F) Certificate of Analysis. ABC will provide to NeoRx a certificate of
analysis in a form agreed to by the parties and in compliance with all
applicable laws, for each batch of Product, provided a certificate of analysis
for (166)HoCl(3) is provided to ABC by XXXX prior to completion of the Process.
(G) Waste Disposal. ABC shall be responsible for the treatment and/or
disposal of all waste generated at ABC during the manufacturing process in
accordance with established federal, state and local environmental and OSHA laws
and regulations, and the maintenance of detailed and complete records related
thereto.
II. PURCHASE ORDERS
(A) Purchase Orders. NeoRx will deliver to ABC by the close of business
on Monday of each week during the term of this Agreement, a written or
electronic purchase order for batch Processing (and whether each batch is a [*]
that NeoRx desires to purchase during the following calendar week. Each purchase
order will also specify the delivery dates and the number of doses of Product
that are to be shipped to each location. Each dose shall be shipped in such
manner, and to such location, as directed by NeoRx and as permitted by XXXX HP.
(B) Contradictory Provisions. To the extent any purchase order, or
related invoice, contains any provisions contrary to the terms of this
Agreement, such contrary provisions shall have no force or effect and the terms
of this Agreement shall control.
III. FEES
(A) Project Initiation Fees. NeoRx agrees to pay ABC [*] as full
compensation for services rendered and expenses incurred on behalf of NeoRx but
beyond the scope of the Clinical Manufacture and Supply Agreement dated
September 1, 2000. These fees are to be paid in [*] (the "Monthly Project
Initiation Fees").
(B) Full-Time Equivalent Fees. For the duration of the Agreement, NeoRx
agrees to pay ABC [*] per month (the "Full-Time Equivalent Fees") for providing
[*] to NeoRx in support of this Agreement and other projects as designated by
NeoRx and agreed to by ABC. In the
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event of any necessary change [*], ABC shall immediately notify NeoRx, and the
parties shall work together in good faith [*].
(C) Process Fees. NeoRx and ABC acknowledge the developmental nature of
the Process and that unanticipated procedures or additional Process revisions
may be required. Accordingly, Process fees include a fixed per batch component
for the Process, in accordance with normal protocol and batch record
requirements as of the date of the Agreement, and a time and material component
for variable costs and additional Process revisions.
(1) Fixed Process Fees. For each batch Processed during the term
of this Agreement, NeoRx shall pay ABC a fee of [*]. The price per batch
includes the cost of [*] to manufacture the product.
(2) Time and Material Process Fees. NeoRx shall reimburse ABC for
[*]. The fees described in this Section III(C)(2) are collectively
referred to as the "Process Time and Material Fees."
(D) QA/QC Fees. Consistent with Process fees, the QA/QC fees include a
fixed per batch component for normal Process QA/QC testing, in accordance with
normal protocol and batch record requirements as of the date of this Agreement,
and a time and material component for variable costs and additional QA/QC
testing revisions.
(1) Fixed QA/QC Fees. For each batch Processed during the term of
this Agreement, NeoRx shall pay ABC a fee of [*]. The price per batch
includes [*].
(2) Time and Material QA/QC Fees. NeoRx shall reimburse ABC for
[*]; provided, however the parties agree that ABC shall incur no costs
under this Section III(C)(2) without NeoRx's prior written approval. The
fees described in this Section III(C)(2) are collectively referred to as
the "QA/QC Time and Material Fees."
(E) Minimum Purchase Requirement. During the period from the effective
date of the Agreement until December 31, 2002, NeoRx agrees to pay, at a
minimum, [*].
IV. BILLING AND PAYMENT TERMS
ABC shall invoice NeoRx periodically, but at least monthly, for fees
earned and defined in Section III. NeoRx shall pay such invoices within thirty
(30) days of its receipt. All invoices that remain unpaid after sixty (60) days
of NeoRx's receipt thereof shall accrue interest at the rate of 1.5% per month.
ABC shall reference the applicable purchase orders on all invoices. If NeoRx
disagrees for any reason with an amount of an invoice, NeoRx shall notify ABC in
writing of such a disagreement within ten (10) business days of receipt of such
invoice, and the parties shall promptly endeavor to resolve the dispute in good
faith.
V. SHIPPING TERMS
NeoRx will be responsible for the shipment of the Product and liable for
any losses resulting from such shipment. NeoRx, in consultation with ABC, shall
arrange for the shipment
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of the Product from the Facility to NeoRx, or such other location(s) as
determined by NeoRx. NeoRx shall be responsible for the payment of all shipping
charges (including, without limitation, freight, handling, insurance and all
other transportation-related items associated with such shipments).
VI. TERM AND TERMINATION
This Agreement will continue through [*]; provided, however, that either
party may terminate this agreement after [*], upon 180 days prior written notice
(such notice cannot be given prior to [*]); and provided, however, that either
party may terminate this Agreement if the other party breaches any of its
obligations hereunder and does not cure such breach within ten (10) days of
written notice or, if such breach is of a nature which, using its best efforts,
the breaching party cannot cure within ten (10) days, if the breaching party
fails to cure such breach within thirty (30) days after the expiration of the
cure period. Notwithstanding any provision in this Agreement to the contrary,
ABC shall continue to Process the Product and deliver the Product in response to
any Purchase Order, through the date of termination, unless such Process and
delivery requirements are waived in writing by NeoRx.
Upon termination by NeoRx (unless as a result of breach which is not cured
by ABC) or breach which is not cured by NeoRx or expiration of this Agreement,
ownership of all equipment and instrumentation used in the Process and QA/QC
testing and maintained at the Facility will be transferred from NeoRx to ABC;
provided, however, that ABC will keep the Facility intact through [*] to permit
NeoRx and FDA inspectors to access and inspect the Facility and Process to
ensure that the Product was manufactured and released in accordance with cGMP
and the Product specifications as set forth on Exhibit A; [*].
VII. MISCELLANEOUS
(A) Each party may receive information from the other party that the
receiving party should reasonably believe is confidential. Each party will hold
the other party's confidential information in confidence, including the terms of
this Agreement, and will disclose such information to persons on a need to know
basis only.
(B) This Agreement contains the entire understanding of the parties and
supersedes all prior agreements and understandings, and may not be modified, nor
any term waived, except by the unanimous written consent of the parties.
(C) The parties are acting as independent contractors and independent
employers. Nothing herein shall be construed as creating a partnership, joint
employer or agency relationship between the parties and no party shall have
authority to bind the other in any respect.
(D) In the event any provision of this Agreement is held unenforceable
under applicable law, the remainder of the Agreement shall remain valid.
(E) No patent, trademark, logo, copyright or other intellectual property
rights are conveyed by this Agreement, and neither party shall have the right to
use the other parties intellectual property for any purpose whatsoever without
prior written consent.
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(F) NeoRx assumes responsibility for payment or settlement of all
charges from [*]. NeoRx agrees to indemnify and hold ABC harmless with respect
to the resolution of any [*].
(G) During the Term of this Agreement, neither Party shall make any
press release or other disclosure of the terms of this Agreement without the
prior written consent of the other Party.
(H) ABC will be excused from performing the Process if its performance
is delayed or prevented by any cause beyond ABC's reasonable control including,
but not limited to, acts of God, fire, explosion, earthquake, disease, weather,
war, sabotage, government action, or accidents. Performance shall be excused
only to the extent of and during the reasonable continuance of such cause. If
such cause results in loss or damage to the materials used in the Process, NeoRx
will hold ABC harmless for any such loss or damage. ABC will immediately notify
client if, because of any of the causes referred herein, ABC is unable to
complete a Process. If any part of the Process is rendered invalid because of
such cause, ABC will, on written request from NeoRx, repeat the Process at the
cost of NeoRx. Performance shall also be excused if the FDA (or other
governmental agency with authority), Missouri Department of Health or other
regulatory agency orders ABC to cease Processing the Product or orders NeoRx to
permanently cease developing or utilizing the Product.
(I) NeoRx will be excused from performance under this Agreement if such
performance is delayed or prevented by any cause beyond NeoRx's reasonable
control including, but not limited to, acts of God, fire, explosion, earthquake,
disease, weather, war, sabotage, government action, or accidents. Performance
shall be excused only to the extent of and during the reasonable continuance of
such cause. Performance shall also be excused if the FDA (or other governmental
agency with authority), Missouri Department of Health or other regulatory agency
orders ABC to cease Processing the Product or orders NeoRx to permanently cease
developing or utilizing the Product.
(J) ABC will not be liable to NeoRx for any loss or expense resulting
from any claim arising out of NeoRx's sale, use or marketing of the Product. In
no event will ABC be liable for any lost profits or other indirect or
consequential loss or damage incurred by NeoRx.
(K) Each Party shall defend, indemnify, and hold harmless the other
Party, its officers, agents, employees and Affiliates (collectively, the
"Indemnified Party") from any third party loss, claim, action, damage, expense
or liability (including defense costs and reasonable attorneys' fees) arising
out of the Indemnifying Party's (a) breach, violation or non fulfillment of any
of its covenant, agreements, representations or warranties under this Agreement,
(b) handling, possession, or use of the Product, (c) negligence or willful
misconduct, or (d) breach of any third party's trade secret right, except to the
extent that such loss, claim, action, damage, expense or liability is based on,
arises out of, or is due to the negligence or willful misconduct of, or breach
of this Agreement by the Indemnified Party.
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VIII. INSURANCE
(A) Product Liability Insurance. NeoRx shall obtain and maintain in
effect, with financially sound and reputable insurers, carrying no less than a
Best Rating of A V., Clinical Trial Products Liability insurance or indemnity
policies in a form acceptable to both parties which name ABC as an additional
insured, with respect to the manufacture, sale and use of commercial products
produced by NeoRx that contain Products. Such insurance policies shall be in an
amount not less than [*] per occurrence and in the aggregate.
(B) Manufacturer's Insurance. ABC shall obtain and maintain in effect in
a form acceptable to both parties, with financially sound and reputable insurers
carrying no less than a Best Rating of A V., insurance or indemnity policies as
described in section VIII(D) with a minimum aggregate coverage of not less than
[*] per occurrence and in the aggregate, naming NeoRx as an additional insured,
with respect to the Processing of the Products according to the Requirements.
(C) Evidence of Insurance. Each party shall supply to the other copies
of certificates of insurance giving evidence of procurement of the insurance in
the amounts specified in this Article VIII (including the naming of the other
party as an additional insured, where required).
(D) Type of Insurance. ABC will carry the following types of insurance -
Commercial, General Liability, Products Liability, and property insurance with
"all risk" coverage on a replacement cost and agreed amount basis, including
coverage for business interruption, contingent business interruption, extra
expense covering lost profits and continuing payroll and endorsed to include
coverage for the extended period of indemnity in a form acceptable to both
parties. Both parties also acknowledge that ABC is actively pursuing the
establishment of pollution/radioactive contamination liability insurance and
will have obtained such coverage on or about March 1, 2001.
IN WITNESS WHEREOF, each party has caused this Agreement to be executed by
a duly authorized representative, effective on this date first set forth above.
NEORX CORPORATION ABC LABORATORIES, INC.
By:___________________________________ By:__________________________________
Name:_________________________________ Name:________________________________
Title:________________________________ Title:_______________________________
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EXHIBIT A
ITEM SPECIFICATIONS
[*]
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