EXHIBIT 10.8
AMENDMENT
This agreement is entered into by and between CHIRON CORPORATION, a
Delaware corporation ("Chiron") and GEN-PROBE INCORPORATED, a Delaware
corporation ("Gen-Probe").
RECITALS
WHEREAS, Chiron and Gen-Probe signed an agreement on June 11, 1998 with
respect to Products for the Blood Screening Field and Clinical Diagnostic Field
(the "Agreement").
WHEREAS, the parties desire to amend the Agreement as set forth in this
Amendment in order to facilitate the purposes of the Agreement.
AGREEMENT
In consideration of the facts recited above and the mutual commitments set
forth below, the parties agree as follows:
1. Article 14 of the Agreement shall be and is hereby amended to read as
follows:
"In consideration for the rights originally granted to Chiron by
this Agreement with respect to TMA and HPA, Chiron shall pay to Gen-Probe,
or shall cause Bayer Corporation to pay to Gen-Probe, the following
nonrefundable amounts upon the occurrence of each event set forth below:
(1) ten million dollars ($10,000,000) upon the Effective Date; and
(2) eight and one-half million dollars ($8,500,000) upon the first
to occur of the following:
(a) (i) Gen-Probe certifies to Chiron that Gen-Probe has
completed manufacture of a Lot of the Initial Blood Screening Assay
for the qualitative detection of both HCV and HIV-1 at Gen-Probe's
Willow Court facility, which Lot is manufactured in accordance with
FDA Good Manufacturing Processes and includes not less than 400,000
tests labeled for IVD distribution outside the United States; and
(ii) Gen-Probe has released such tests for foreign sale; and (iii)
Gen-Probe delivers to Chiron a copy of the Certificate of Analysis
with respect to such Lot, in form reasonably satisfactory to
Chiron, signed by Gen-Probe's quality assurance
organization; or
(b) Gen-Probe certifies to Chiron that it has successfully
completed validation of the Enhanced Semi-Automated System
("ESAS") for use with the Initial Blood Screening Assay,
including both instrument hardware and software, and
delivers or makes available to Chiron a copy of the
Validation Report with respect to both the instrument and
the software, signed by Gen-Probe's quality assurance
organization.
(3) six and one-half million dollars ($6,500,000) upon the date on
which the following has occurred: (a) thirty (30) days has passed since
submission to the FDA of an Investigational New Device application for the
Initial Blood Screening Assay for the qualitative detection of both HCV and
HIV-1, specifying the use of the assay on the Tigris Instrument in the Blood
Screening Field; provided that no clinical hold notice has been issued by the
FDA as to such application, and no agreement has been reached with the FDA to
delay the clinical trial, within such thirty-day period; and (b) Gen-Probe has
installed a Tigris Instrument pursuant to the IND referred to above, at the
clinical site and completed technologist training and proficiency testing with
a panel of specimens and control materials with respect to the instrument and
the Initial Blood Screening Assay for the qualitative detection of both HCV and
HIV-1.
(4) ten million dollars ($10,000,000) upon receipt of the required
marketing approval from the FDA to market the Initial Blood Screening Assay for
the qualitative detection of both HCV and HIV-1 in the United States for use in
the Blood Screening Field on the Tigris Instrument.
Page 2 of 3
2. Except as expressly amended above, the Agreement shall remain in
full force and effect.
By the signatures of their authorized officers below, Gen-Probe and
Chiron adopt this amendment as of December 7, 1999.
CHIRON CORPORATION GEN-PROBE INCORPORATED
/s/ Xxxxx Xxxxx /s/ Xxxxx X. Xxxxxxxx
By ____________________________ By _______________________
Xxxxx X. Xxxxxxxx
Title: President, Blood Testing President and
Chiron Chief Executive Officer
Page 3 of 3
