FOURTH AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT OF DECEMBER 7 2003

 

THIS FOURTH AMENDMENT TO THE MANUFACTURING AND SUPPLY AGREEMENT DATED DECEMBER 7 2003 (“4^th Amendment”) is dated as of 02 February 2007, 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”).

 

 

The Parties have executed that certain Manufacturing and Supply Agreement by and between the Parties dated December 7, 2003, as amended 14 March 2005 (the “1^st Amendment”), as amended 19 May 2006 (the “2^nd Amendment”), as amended 06 November 2006 (the “3^rd Amendment”) (collectively, the “Agreement”) and wish now to further amend said Agreement.

 

Genentech desires Lonza to repack the [*] column with new [*]. Lonza shall plan to repack the [*] column at not more than [*] with the column repacks targeted following the [*]. Lonza shall only repack the [*] column when their manufacturing schedule provides the opportunity to [*] repacks without impacting the manufacturing schedule. 

 

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.	[*] Repack. Lonza shall repack the [*] Column with [*]. Lonza shall use its Commercially Reasonable Best Efforts to schedule such repacking so as to minimize any impact to the manufacturing schedule. Subject to the foregoing, Lonza shall schedule such repacking to occur [*].

 

2.

Loss of Commercial Runs as a Result of [*] Repack.  It is understood and agreed by the Parties that such repacking and subsequent testing of the [*] Column (as described above in Section 1 of this 4th Amendment) may result in unexpected delays to the manufacturing schedule which could jeopardize the quality of one or more Commercial Run(s) commenced and in process during the [*]. If as a result of such repacking and testing (and not for any other act or omission of Lonza), the quality of one or more of such Commercial Run(s) are compromised such that Lonza has to discontinue and/or discard one or more of such

 

 

Commercial Run(s), [*]. Except as provided below in Section 3 of this 4^th Amendment, [*] for such lost Commercial Runs, regardless of such number of Commercial Runs lost on either or both scheduled repacks.

 

3.

Milestone Payment for Calendar Year 2006. In addition to the foregoing, if as a result of such repacking and testing (and not for any other act or omission of Lonza), the quality of one or more of such Commercial Run(s) in the [*] are compromised such that Lonza has to discontinue and/or discard one or more of such Commercial Run(s), Genentech agrees to credit one of such lost Commercial Runs as [*] solely for the purpose of determining whether Lonza has met the milestone set forth in Section 6.4.3(d)(ii) of the Agreement

 

By way of example only:

 

4.	All terms and conditions of the Agreement not modified by this 4th Amendment shall continue in full force and effect in accordance with their terms. 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 4th Amendment to be executed as of the Effective Date.

 

GENENTECH, INC.
By:	/s/  PHILIPPA NORMAN
Name:	Philippa Norman
Title:	Vice President, Manufacturing Collaborations
LONZA BIOLOGICS, INC.
By:	/s/  STEPHAN KUTZER
Name:	Stephan Kutzer
Title:	Chief Operating Officer
LONZA BIOLOGICS, PLC
By:	/s/  STEPHAN KUTZER
Name:	Stephan Kutzer
Title:	Chief Operating Officer