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EXHIBIT 10.34.2
AMENDMENT II
Amendment to the Facility Set-Up and Contract Manufacturing Agreement
and License Agreement
between
RADIANCE MEDICAL SYSTEMS INC.
hereafter "RMS"
located at 13700 Alton Parkway, Suite 160,
in Irvine, California, 92618
and
BEBIG ISOTOPENTECHNIK AND UMWELTDIAGNOSTIK GmbH,
hereafter "BEBIG"
located at Robert-Rossie-Str. 10,
in 13125 Berlin, Germany
BACKGROUND
RMS and BEBIG have signed a FACILITY SET-UP AND CONTRACT MANUFACTURING
AGREEMENT including the ADDENDUM TO FACILITY SET-UP AND CONTRACT MANUFACTURING
AGREEMENT and a LICENSE AGREEMENT (collectively referred to as "the
Agreements"), both amended by the AMENDMENT TO THE FACILITY SET-UP AND CONTRACT
MANUFACTURING AGREEMENT AND THE LICENSE AGREEMENT (referred to as "Amendment
1").
RMS desires to extend the future capacity of production determined by the
FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT and therefore appoints
BEBIG to install additional two new Production Lines at the Facility.
In the light of the above, both parties desire to amend the existing Agreements
and the Amendment 1 as follows:
1. PROVISION OF ADDITIONAL FACULTY SPACE
BEBIG will prepare and make available another 65 square meters (referred to as
the "New Facility") of laboratory space next to the existing laboratory in its
building at Robert-Rossie-Str. 10, 13125 Berlin, Germany. The New Facility
shall be suitable for handling and production of radioactive balloon catheters.
In return RMS will pay to BEBIG an additional one-time facility fee of $US
50,000 (referred to as "Additional Facility Fee").
2. EXTENSION OF RENTAL TERM
The extension fee in 1(c) FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT
will be increased to $US 75,000, payable by Radiance upon the beginning of
each new Rental Term. This increase will not apply for the first extension of
the Rental Term.
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3. ADDITIONAL EQUIPMENT REQUIREMENTS AND VALIDATION
BEBIG will establish two new assembly platform containment cells according to
the provisions of the FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT
including the ADDENDUM TO FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT.
After installation of the equipment Bebig will carry out the Process Validation
after giving written notice to RMS. All material costs and third party expenses
during the validation process shall be borne by RMS.
Bebig will purchase the Components for the assembly platforms from RMS for a
price of US$ 450,000, payable upon receipt of shipment.
4. COMPENSATIONS
RMS will reimburse BEBIG or its affiliates for the new production requirements
with an investment contribution of US$ 585,000 excluding taxes if any. This
amount includes the costs for fabrication and validation of the two additional
containment cells.
Radiance will reimburse BEBIG for its additional activities agreed by this
Amendment II with payments are due at the following dates:
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MILESTONE TARGET DATE AMOUNT
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Upon Execution of the Amendment II
"Additional Facility Fee" (see section 1) Effective Date 50,000 US$
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Installation of the Containment cells
(containment cells ready for set-up March 2001 377,000 US$
of assembly platforms)
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Assembly platforms readiness
(cold and hot qualifications done) April 2001 208,000 US$
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TOTAL: 635,000 US$
5. LICENSE FEE OFFSETS
Both parties agree, that amounts to be paid by RMS according to the provisions
of this Amendment II are not subject to offsetting of the license fee or
royalties as provided by sec. 4 LICENSE AGREEMENT.
6. MAINTENANCE COSTS
Both parties agree, that RMS covers all maintenance cost of the equipment
delivered by RMS during the rental term. Maintenance cost on the before
mentioned equipment is billed back to RMS at cost.
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7. MISCELLANEOUS
Except as specifically modified by this Amendment II, all terms and conditions
of the Agreements and Amendment I shall continue unchanged.
Date: 2/12/01 Date: 2/02/01
/s/ DR. ANDRE HESS /s/ JOSEPH A. BISHOP
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BEBIG GmbH Radiance Medical Systems, Inc.
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