AMENDMENT NO. 9 TO AGREEMENT
EXHIBIT 10.95
AMENDMENT NO. 9 TO
AGREEMENT
AGREEMENT
This Amendment No. 9 (“Amendment No. 9”) is entered into effective as of July 1, 2006 (the
“Amendment Effective Date”), pursuant to and amending that certain Agreement between Gen-Probe
Incorporated, a Delaware corporation (“Gen-Probe”) and Novartis Vaccines and Diagnostics, Inc., a
Delaware corporation (“Novartis Vaccines and Diagnostics”). Capitalized terms used but not defined
herein shall have the meanings set forth in the Agreement.
Recitals
A. Prior to April 19, 2006, the legal name of Novartis Vaccines and Diagnostics, Inc. was
Chiron Corporation. In this Amendment No. 9, Novartis Vaccines and Diagnostics, Inc. is referred
to as “Chiron” with respect to events prior to April 19, 2006
B. The parties entered into the Agreement as of June 11, 1998 pursuant to which, among other
things, the parties described their respective rights and obligations with respect to the
development, manufacture, marketing and distribution of Products in the Blood Screening and
Clinical Diagnostic Fields.
C. The Agreement has been previously amended and supplemented by further written agreements of
the parties.
D. Subsequent to the execution of the Agreement, Chiron assigned its rights and obligations
with respect to Clinical Diagnostic Products to Chiron Diagnostics Corporation (“CDC”), and sold
the common stock of CDC to Bayer Corporation (CDC, Bayer Corporation, and Bayer Corporation’s
affiliates being collectively referred to as “Bayer”). Chiron retained all rights and obligations
under the Agreement with respect to Blood Screening Products. This amendment is effective as
between Chiron and Gen-Probe with respect to Blood Screening Products only, and nothing herein
shall affect any rights or obligations of Gen-Probe or Bayer with respect to Clinical Diagnostic
Products.
E. Gen-Probe has previously developed an end-point detection assay for the quantitative
detection of human immunodeficiency virus (the “End-Point HIV QC Assay”), to be used as a quality
control assay in connection with the development and manufacture of Blood Screening Assays for HIV
and Clinical Diagnostic Assays for HIV pursuant to the Agreement.
F. As part of its continuous improvement program, Gen-Probe has commenced development of a
next generation quality control assay using real time detection technology (the Real Time HIV QC
Assay).
NOW, THEREFORE, for and in consideration of the mutual covenants and agreements set forth in
this Amendment No. 9, the parties agree as follows:
1. Unless otherwise stated herein, all capitalized terms shall have the meaning set forth in
the Collaboration Agreement.
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2. For the avoidance of doubt, Novartis Vaccines and Diagnostics agrees that Gen-Probe’s
development of the Real Time HIV QC Assay for use as a quality control assay, to be used for the
development and manufacture of Blood Screening Assays for use in the Blood Screening Field, is
authorized by and pursuant to section 3.1.5(a) and section 3.2.6(a) of the Collaboration Agreement.
Novartis Vaccines and Diagnostics hereby expressly consents to the development of the Real Time
HIV QC Assay for use in the Blood Screening Field.
3. Nothing herein shall be construed as a license to develop or manufacture any product for
use in the Clinical Diagnostic Field. Gen-Probe agrees that it will not undertake any development
activities with respect to the Real Time HIV QC Assay that are unique and specific to the use of
such assay in the Clinical Diagnostic Field without the express written consent of Bayer HealthCare
LLC, if such Assay would infringe a Valid Claim of a Chiron HIV Patent. By way of example and not
of limitation, Gen-Probe agrees that it will not undertake any clinical studies, clinical trials,
or regulatory submissions for clinical diagnostic use of the Real Time HCV QC Assay without the
express written consent of Bayer HealthCare LLC, if such Assay would infringe a Valid Claim of a
Chiron HIV Patent. Chiron shall have reasonable rights of inspection and audit to assure
Gen-Probe’s compliance with this paragraph.
4. This Amendment No. 9 shall not be interpreted to suggest that the development and use of
the Real Time HIV QC Assay, for use solely as a quality control assay in connection with the
manufacture of Clinical Diagnostic Assays, is either authorized or not authorized pursuant to
section 4.1.5(a) of the Collaboration Agreement.
5. Except as is expressly set forth in this Amendment No. 9, all other terms and conditions of
the Agreement shall continue in full force and effect.
6. This Amendment No. 9 may be executed in counterparts, each of which shall be an original,
and all of which together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have caused this Amendment No. 9 to be executed and the
persons signing below warrant that they are duly authorized to sign for and on behalf of the
respective parties.
Gen-Probe:
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Novartis Vaccines and Diagnostics: | |
GEN-PROBE INCORPORATED,
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NOVARTIS VACCINES AND DIAGNOSTICS, INC., | |
a Delaware corporation
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a Delaware corporation | |
By: /s/ R. Xxxxxxx Xxxxx
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By: /s/ Xxxx X. Xxxxxxx | |
Its: Vice President & General Counsel
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Its: President — Diagnostics | |
Date: June 22, 2006
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Date: June 23, 2006 |
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