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 228 Bath Road, Slough,
Berkshire SL1 4DX, England ("LB"), Lonza Biologics, Inc. having its
principal place of business at 101 International Drive Portsmouth,
New Hampshire 03801 ("Lonza Inc") (collectively LB and Lonza Inc,
hereinafter "Lonza"), and Genentech, Inc., a Delaware corporation,
having its principal place of business at One DNA Way, South San
Francisco, California 94080 ("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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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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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
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