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:

1.
Installation of 4th Bioreactor. Lonza shall add a fourth bioreactor and
associated equipment to the Lonza Facility.

2.
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.
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 [*]

4.
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.

5.
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, [*]

6.
Rescheduling of the [*] Campaigns. Notwithstanding the Campaign, Campaign
Minimum and Campaign Minimum Run schedule listed on Exhibit A:

 
(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; and

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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.

7.
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 [*.]

9.
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.

GENENTECH, INC.
       
By:
/s/ DAVID EBERSMAN
       
Name:
David Ebersman
 
Title:
Senior Vice President, Finance
             
By:
/s/ PAT YANG
       
Name:
Pat Yang
 
Title:
Senior Vice President, Product Operations
             
LONZA BIOLOGICS, INC.
       
By:
/s/ GERHARD KLEMENT
       
Name:
Gerhard Klement
 
Title:
Chief Operating Officer
       
LONZA BIOLOGICS, PLC
       
By:
/s/ GERHARD KLEMENT
       
Name:
Gerhard Klement
 
Title:
Chief Operating Officer
 

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