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Exhibit 10.18
Lonza
AMENDMENT NO. 2
TO
THE DEVELOPMENT AND MANUFACTURING SERVICES AGREEMENT
DATED 08 JANUARY 2004
BETWEEN
LONZA BIOLOGICS ***
AND
TRUBION PHARMACEUTICALS INC.
Re:
Schedule 2 - Services
Updated Stages
Stage 1 ***
Stage 2 ***
Stage 8 ***
Schedule 2 - Services
New Stages
Add Stage
16 ***
Add Stage
17 ***
Add Stage 18 ***
Schedule 3 - Price and Payment
Updated Price and Payment Terms for Updated Stages and New
Stages
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Lonza
THIS AMENDMENT is made the 20 day July 2004
BETWEEN
1. LONZA
BIOLOGICS ***, the registered office of which is at *** ("LB")
and
2. TRUBION
PHARMACEUTICALS, INC., of 2401 4th Avenue, Suite 1050, Seattle,
WA
98121, USA (herein after referred to as the "Customer").
WHEREAS
A. Customer and
LB entered into a development and manufacturing services
agreement dated 08 January 2004 ("the Agreement"), under which LB
is
required to perform Services relating to the Cell Line and the
Product, as
further described in the Agreement, and
B. Customer
would like LB to perform additional services under the
Agreement,
and
C. LB is
prepared to perform the additional services, and the parties wish
to
amend the Agreement accordingly and to make other revisions to
the
Agreement.
NOW THEREFORE it is agreed as follows:
1.
Amendments to Schedule 2, Stages 1, 2 and 8. Schedule 2 of the
Agreement
shall be amended to revise Stage 1 (Fermentation Process
Evaluation), Stage 2
*** and Stage 8 (Production of *** of cGMP Product at *** Scale),
as follows:
1.1 Stage 1 of Schedule 2 shall now read In its entirety as
follows:
STAGE 1 ***
1.1
OBJECTIVES
***
1.2
ACTIVITIES
***
1.3
DELIVERABLES
1.3.1 A report of activities for the shake flask and lab scale
fermenter activities.
1.3.2 A report of activities performed during virus testing of
the
***.
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1.4
TIMESCALE
This
stage may start upon creation of the *** Cell Line and receipt of
the
*** Cell Line from the Customer. This stage shall be complete upon
issue of the
report for the virus testing activities.
It
is estimated that this stage shall be complete *** from
commencement.
1.2
Stage 2 of Schedule 2 shall now read In its entirety as
follows:
STAGE 2 ***
2.1
OBJECTIVES
***
2.2
ACTIVITIES
***
2.3
DELIVERABLES
2.3.1 A report of activities carried out under this Stage 2 as
detailed in activity 2.2.6.
2.3.2 A one (1) page summary report to the customer for each
ampoule revival during the *** (activity 2.2.5).
2.4
TIMESCALE
Stage 2 may commence as soon as the selected PSS is available from
Stage 1
of the Services.
Stage 2 shall be complete with the issue of the report (activity
2.3.1) and
it is estimated that this report will be issued *** from the
commencement of
Stage 2.
It
is estimated that the *** will be established *** from the
commencement
of Stage 2.
-2-
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1.3
Stage 8 of Schedule 2 shall now read in its entirety as
follows:
STAGE 8 ***
8.1
OBJECTIVES
***
8.2
ACTIVITIES
***
8.3
DELIVERABLES
***
8.4
TIMESCALE
When
the Customer and LB agree to the commencement of this Stage,
this
stage may commence as soon as the *** is available for use and the
Process
development activities and cGMP documents are complete.
This
stage shall be complete upon issue of the certificate of analysis
for
the Batch of Product.
It
is estimated that Product will be delivered *** from commencement
of the
Stage. If Customer requests in writing, the Product can be shipped
in quara
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