EXHIBIT 10.1
AMENDMENT NO. 1 TO LICENSE AGREEMENT
This document, dated July 16, 2003, shall serve as Amendment No. 1 to that
certain License Agreement, with an Effective Date of July 31, 2002 (the "License
Agreement"), by and between Cubist Pharmaceuticals, Inc. ("Cubist") and Sandoz
GmbH (f/k/a Biochemie GbmH) ("SANDOZ"), which Agreement is hereby incorporated
by reference.
WHEREAS, Cubist and Sandoz have executed a letter agreement, dated
July 16, 2003 (the "Letter Agreement"), the terms of which provide that Sandoz
fund a cynomolgus monkey GLP toxicity study;
WHEREAS, upon the execution of the Letter Agreement, Cubist and Sandoz
agree that Schedule 6 of the License Agreement shall be amended as set forth
herein;
NOW THEREFORE, in consideration of the foregoing and the mutual promises
contained herein, the parties agree as follows:
1. Upon execution of the Letter Agreement, Schedule 6 of the License Agreement
shall be deleted and replaced in its entirety with the following:
SCHEDULE 6
(Section 5.3(a) - Criteria for successful completion of GLP Toxicity Studies)
- completion of the 14-day rat, marmoset, and cynomolgus monkey bid
infusion studies and acceptance by Cubist of draft study reports
- obtaining a 4-fold safety margin for the non-observed adverse effect
levels for the rat and cynomolgus monkey studies based on Cmax
comparison to the projected minimal efficacious human dose (i.e., 500
mg q12h), and
- defining a method of monitoring renal toxicity in clinical settings,
i.e., urinary NAG or GST assay, epithelial cells in urinary sediment,
or other appropriate marker
All other terms and conditions of the Agreement shall remain in effect
unless otherwise specifically provided herein.
IN WITNESS WHEREOF, the parties hereto have executed the Agreement
Amendment as of__________.
CUBIST PHARMACEUTICALS, INC. SANDOZ GMBH
By: /s/ Xxxxxxx X. Xxxxxx By: /s/ X. Xxxxxx /s/ X. Xxxxxxxxxxxx
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Name: Xxxxxxx X. Xxxxxx Name: X. Xxxxxx X. Xxxxxxxxxxxx
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Title: C.E.O Title: Head ABRI General Counsel
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Date: 7/28/03 Date: 16-07-2003 July 16, 2003
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