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Exhibit 10.21
AMENDMENT NO. 5
TO
THE DEVELOPMENT AND MANUFACTURING
SERVICES AGREEMENT
DATED 08 JANUARY 2004
BETWEEN
LONZA BIOLOGICS ***
AND
TRUBION
PHARMACEUTICALS, INC.
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THIS AMENDMENT No. 5 ("Fifth Amendment") is made the 18th day of
February, 2005
BETWEEN
LONZA BIOLOGICS *** of *** (hereinafter referred to as "LB"),
and
TRUBION PHARMACEUTICALS, INC., of 2401 4th Avenue, Suite 1050,
Seattle, WA
98121, USA (hereinafter referred to as the "Customer")
WHEREAS
A. LB and the
Customer entered into a development and manufacturing services
agreement ("the Agreement") dated 08 January 2004, pursuant to
which LB
agreed to provide Services to the Customer, and,
B. The Customer
now wishes LB to perform additional services under the
Agreement, and,
C. LB is willing
to perform such additional services on the terms set out in
the
Agreement, and
D. The parties
wish to amend the Agreement in accordance with Clause 13.5
thereto.
NOW THEREFORE IT IS HEREBY AGREED as follows:
1. Two new
stages, Stages 23 and 24, shall be added to Schedule 2 of the
Agreement to read as follows:
STAGE 23 ***
23.1
OBJECTIVES
***
23.2
ACTIVITIES
***
23.3
DELIVERABLES
23.3.1 Copies of all Process specific documentation prepared in
activity 23.2.1 which has not already been supplied to the
Customer
23.4
TIMESCALE
Stage 23 will be scheduled in to the Services in such a way that it
is not
rate limiting and shall be complete when LB and the Customer have
approved the
documentation and when a copy of the approved final bulk Product
specification
has been sent to the Customer.
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It
is estimated that Stage 23 will be complete approximately *** from
the
commencement of Stage 23.
STAGE 24 ***
24.1
OBJECTIVES
***
24.2
ACTIVITIES
***
24.3
DELIVERABLES
24.3.1 A Certificate of Analysis for the Batch of bulk Product
manufactured.
24.3.2 If requested by Customer, a copy of the completed
manufacturing
batch record.
24.3.3 The manufactured Product, including samples and
in-Process
samples to be supplied to Customer as agreed by the parties.
NOTE: ***.
24.4
TIMESCALE
Stage 24 shall be complete upon issue to the Customer of the
Certificate of Analysis for the Batch of Product manufactured.
It is estimated that the Certificate of Analysis will be issued
approximately *** from commencement of this Stage (estimated out of
freeze ***).
If the Customer requests in writing, the Product ca
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