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
      000
      Xxxx Xxxx, Xxxxxx, Xxxxxxxxx XX0 0XX, Xxxxxxx ("LB"), Lonza Biologics, Inc.
      having its principal place of business at 000 Xxxxxxxxxxxxx Xxxxx Xxxxxxxxxx,
      Xxx Xxxxxxxxx 00000 ("Lonza Inc") (collectively LB and Lonza Inc, hereinafter
      "Lonza"), and Genentech, Inc., a Delaware corporation, having its principal
      place of business at Xxx XXX Xxx, Xxxxx Xxx Xxxxxxxxx, Xxxxxxxxxx 00000
      ("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.

            8
                
            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/
                XXXXX XXXXXXXX

            Name:

            Xxxxx
                Xxxxxxxx

            Title:

            Senior
                Vice President, Finance

            By:

            /s/
                XXX XXXX

            Name:

            Xxx
                Xxxx

            Title:

            Senior
                Vice President, Product Operations

            LONZA
                BIOLOGICS, INC.

            By:

            /s/
                XXXXXXX XXXXXXX

            Name:

            Xxxxxxx
                Xxxxxxx

            Title:

            Chief
                Operating Officer

            LONZA
                BIOLOGICS, PLC

            By:

            /s/
                XXXXXXX XXXXXXX

            Name:

            Xxxxxxx
                Xxxxxxx

            Title:

            Chief
                Operating Officer

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Table of Contents

FIRST AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT DATED DECEMBER 7 2003

Document Metadata

GENENTECH, INC.

By:	/s/ XXXXX XXXXXXXX

Name:	Xxxxx Xxxxxxxx
Title:	Senior Vice President, Finance


By:	/s/ XXX XXXX

Name:	Xxx Xxxx
Title:	Senior Vice President, Product Operations


LONZA BIOLOGICS, INC.

By:	/s/ XXXXXXX XXXXXXX

Name:	Xxxxxxx Xxxxxxx
Title:	Chief Operating Officer

LONZA BIOLOGICS, PLC

By:	/s/ XXXXXXX XXXXXXX

Name:	Xxxxxxx Xxxxxxx
Title:	Chief Operating Officer