FIRST AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT DATED DECEMBER 7 2003
EXHIBIT 10.28
FIRST
AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT
DATED
DECEMBER 7 2003
THIS
FIRST AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT DATED DECEMBER 7
2003
("Amendment") is made effective as of 14 March 2005 (the “Effective Date”), by
and between Lonza Biologics PLC, having its principal place of business at
▇▇▇
▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇▇▇ ("LB"), Lonza Biologics, Inc.
having its principal place of business at ▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇,
▇▇▇ ▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ ("Lonza Inc") (collectively LB and Lonza Inc, hereinafter
"Lonza"), and Genentech, Inc., a Delaware corporation, having its principal
place of business at ▇▇▇ ▇▇▇ ▇▇▇, ▇▇▇▇▇ ▇▇▇ ▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇
("Genentech").
BACKGROUND
The
Parties have executed that certain Manufacturing and Supply Agreement by and
between the Parties dated December 7, 2003 (“Agreement”) and wish now to amend
said Agreement.
Lonza
desires to add a fourth bioreactor to the Lonza Facility.
Genentech
desires to utilize some of the capacity the fourth bioreactor will provide.
NOW,
THEREFORE, IN CONSIDERATION OF the mutual covenants set forth in this Agreement,
and for other good and valuable consideration, the receipt and sufficiency
of
which are hereby acknowledged, the Parties hereby agree as follows:
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1.
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Installation
of 4th Bioreactor.
Lonza shall add a fourth bioreactor and associated equipment to the
Lonza
Facility.
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2.
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Validation
of 4th Bioreactor.
Following installation of such fourth bioreactor, Lonza shall use
its
Commercially Reasonable Best Efforts to validate such reactor for
use with
the Manufacturing Process and in order to commence Commercial Production
of Bulk Drug (i.e., commencement of the first Commerical Run) with
such
fourth bioreactor, as soon as is reasonably practicable, but in any
event
no later than [*]
Campaign,
[*];
provided,
in no event shall Lonza take any action that would impair or delay
its
obligation to conduct Commercial Production of Bulk Drug in the existing
reactors at the Lonza Facility and deliver Bulk Drug in the amounts
and
time frame specified in the Agreement. Lonza shall notify Genentech
in
writing promptly upon Lonza becoming aware of any such activity that
may
result in such impairment or delay, and shall not initiate any such
activity without obtaining Genentech’s prior written review and
approval.
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3.
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Qualification
Runs on 4th Bioreactor.
Without limiting the foregoing, Lonza shall use Commercially Reasonable
Best Efforts to perform [*]
Qualification
Runs to produce at least [*]
on
such fourth bioreactor by no later than [*]
in
this Section of the Amendment; provided, Genentech shall have no
obligation to pay Lonza for more than [*].
Subject
to the foregoing, for each [*]
manufactured
on such fourth bioreactor in conformance with cGMP, the Bulk Drug
Specifications, the Target Yield, and the warranties in Section 7.1,
Genentech shall pay Lonza an amount equal to [*].
Such
amounts shall be the Purchase Price for such Qualifications Batches.
Genentech may make whatever further uses of such Batches, including
without limitation, any Product therefrom, as it shall determine
is
appropriate. Lonza shall use Commercially Reasonable Best Efforts
to
provide all the required documentation to Genentech to support the
sBLA
filing for the fourth bioreactor by no later than the [*]
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4.
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Commercial
Production on 4th Bioreactor.
Following the completion at commercial scale of at least [*]
on
such fourth bioreactor that complies with cGMP, the Bulk Drug
Specifications, the Target Yield, and the warranties in Section 7.1,
and
execution and delivery by Lonza of the related Certificates of Compliance
and Certificates of Testing, Genentech shall have the right to provide
written notice to Lonza to commence, and following receipt of such
notice
Lonza shall commence, Commercial Production of Bulk Drug with such
fourth
bioreactor under this Agreement.
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5.
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Adjustments
to Annual Minimums following Commencement of Commercial Production
on the
4th Bioreactor.
Concurrent with the Calendar Quarter in which Commercial Production
of
Bulk Drug on such fourth bioreactor commences, the Campaign Minimum
Runs
and Successful Commercial Batches for such Calendar Quarter and each
Calendar Quarter thereafter, as detailed in Exhibit A of the Agreement,
shall be amended to [*]
(i.e., as of the effective date of this Amendment,
[*]
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6.
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Rescheduling
of the [*] Campaigns.
Notwithstanding the Campaign, Campaign Minimum and Campaign Minimum
Run
schedule listed on Exhibit A:
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(i)
the [*]Campaign
scheduled to commence in the [*]
shall be rescheduled to the [*]
such Campaign to commence on [*]
and
continue for a [*]
during
which time Lonza shall be obligated to perform [*]Campaign
Minimum Runs;
(ii)
the [*]Campaigns
scheduled for the [*]
and
shall be rescheduled to the [*]
such Campaign to commence on [*]
and continue
for a [*]
during
which time Lonza shall be obligated to perform [*]
campaign
Minimum Runs. It is the expectation of the Parties that [*]
campaign
Minimum Runs shall be allocated to conducting the [*]
on the fourth bioreactor, as further described in Section 3 above;
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(iii)
the [*]
Campaign
scheduled for the [*]
shall
be rescheduled to commence on [*]
and
continue for a Campaign [*]
during
which time Lonza shall be obligated to perform [*]
Campaign
Minimum Runs.
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7.
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Cross-Contamination.
In order to minimize the risk of cross-contamination of Product with
another product at the Lonza Facility, during the period of time
that
Lonza is processing any Bulk Drug in any of the existing bioreactors
at
the Lonza Facility, Lonza shall not introduce or process any other
product
in the fourth bioreactor after the process piping of such fourth
bioreactor is connected to the existing
bioreactors.
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Genentech
[*] 4th Bioreactor. With
respect to [*.]
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9.
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All
terms and conditions of the Agreement not modified by this Amendment
shall
continue in full force and effect. All capitalized terms not otherwise
defined herein shall have the same definition as in the
Agreement.
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IN
WITNESS WHEREOF, the Parties have caused this Amendment to be executed as of
the
Effective Date.
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GENENTECH,
INC.
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By:
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/s/
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Name:
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▇▇▇▇▇
▇▇▇▇▇▇▇▇
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Title:
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Senior
Vice President, Finance
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By:
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/s/
▇▇▇ ▇▇▇▇
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Name:
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▇▇▇
▇▇▇▇
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Title:
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Senior
Vice President, Product Operations
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LONZA
BIOLOGICS, INC.
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By:
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/s/
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
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Name:
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▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
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Title:
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Chief
Operating Officer
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LONZA
BIOLOGICS, PLC
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By:
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/s/
▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
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Name:
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▇▇▇▇▇▇▇
▇▇▇▇▇▇▇
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Title:
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Chief
Operating Officer
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