1
EXHIBIT 10.34.3
AMENDMENT III
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 180,
in Irvine, California, 92618
and
BEBIG ISOTOPENTECHNIK AND UMWELTDIAGNOSTIK GmbH,
hereafter "BEBIG"
located at Robert-Rossie-Str. 10,
in 13125 Berlin, Germany
BACKGROUND TO AMENDMENT
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 wants BEBIG to provide additional services for the radioactive balloon
catheter. BEBIG intends to install and perform these services. Therefore, both
parties desire to amend the Agreements and Amendment 1.
On these premises the parties agree as follows:
1. CONTRACT MANUFACTURING, PRODUCTION CAPACITY AND SERVICES
BEBIG will provide additional services and materials to RMS for the
radioactive balloon catheter. All services are described in detail in
Appendix A. All costs related to the materials and services described in
Appendix A shall be covered by BEBIG.
Bebig will provide production capacity according to the following schedule:
PRODUCTION CAPACITY
TIME PERIOD PER MONTH
----------- -------------------
April - June 2001 40
July - September 2001 124
October - December 2001 275
January - March 2002 800
BEBIG will receive from RMS, 3 months prior to each quarter, an updated
build plan forecast on a rolling basis giving the production capacity
needed. All exceeding amount with respect to above mentioned schedule will
be considered on a best effort basis.
2
2. COMPENSATIONS
a) RETAINER
RMS and BEBIG agree that as a compensation for maintaining the production
of radioactive balloon catheters, RMS shall pay a fixed price of US $20,000
per month as a retainer. RMS shall pay such retainer for each month after
Delivery of First Product, but not later than April 2001. Payment shall be
due on the 5th of each calendar month.
b) PRICE PER CATHETER
i) RMS will pay to BEBIG the following prices for each unit of product
depending on the number of ordered and manufactured products per
month:
ORDERED AND MANUFACTURED PRICE PER CATHETER
CATHETERS PER MONTH US$
----------------------------------------------------------------
1-40 380
----------------------------------------------------------------
Each additional unit to maximum of 120 375
----------------------------------------------------------------
Each additional unit to maximum of 280 350
----------------------------------------------------------------
Each additional unit to maximum of 800 306
----------------------------------------------------------------
ii) The price includes the process fee of US$ 80 from sec 6.d of the
FACILITY SET-UP AND CONTRACT MANUFACTURING AGREEMENT and shall be due
within 7 days after the end of the month in which the product was
manufactured. Prices quoted without taxes if any and Ex Works Berlin.
iii) In the event of an increase in the production cost, BEBIG may add to
the above mentioned prices possible increases in material and
production costs provided these increases exceed 10% in each contract
year. BEBIG shall provide RMS two months in advance with evidence of
such price increases and the impact of it on the cost of the product,
which RMS will not unreasonable refuse.
3. FORECAST AND BINDING ORDER
a) BEBIG will receive from RMS, 4 weeks prior to the date of
manufacture, a non-binding supply requirement forecast on a rolling
basis giving the amount of catheters needed.
b) BEBIG will receive from RMS, 2 weeks prior to the date of
manufacture, a firm order. The firm order shall not exceed the
production capacity as indicated in sec. 1 and the forecast. All
exceeding amount will be considered on a best effort basis.
4. LICENSE FEE OFFSETS
Payments of sec 2, in this Amendment III shall not be subject to
offsetting of the license fee or royalties as provided by sec 4, License
Agreement.
5. MISCELLANEOUS
a) The terms of this Amendment III shall be for a period of one (1) year
from 1 April 2001. This Amendment III will automatically be extended
for one (1) year on the basis of the numbers of the last quarter of
the contract year unless a written cancellation is given by either
party at least two (2) months in advance of a renewal date.
2
3
b) Except as specifically modified by this amendment, all terms and conditions
of the Agreements and conditions shall continue unchanged.
Date: 2/12/01 Date: 2/02/01
/s/ DR. ANDRE HESS /s/ JOSEPH A. BISHOP
- --------------------------- ------------------------------
BEBIG GmbH Radiance Medical Systems, Inc.
3
4
APPENDIX A
SERVICES PROVIDED BY BEBIG
BEBIG will provide the following services for RMS:
1. RAW MATERIAL SUPPLY
- Provision of a sufficient stock of P-32 at its facility
- Procurement of auxiliary material for the chemical process
This does not include the foils themselves.
2. PACKAGING
Provision of packaging materials including:
- pouch
- white chipboard box
- outer shipping carton
- insert for shipping carton
- filler
This does not include tray and lids of the catheter package.
3. STERILIZATION
Gamma sterilization of 25 kGy will be performed. The costs for the
sterilization and for the transportation of the goods from our facilities to
the sterilizer and back are included for the following volume:
Up to 50 catheters/week 1 sterilization/week
51 to 100 catheters/week 2 sterilizations/week
101 to 200 catheters/week 3 sterilizations/week
Requests for additional sterilizations per week will be arranged, but
additional costs will be done by RMS. Costs for any additional or
re-validations of the sterilization process are not included.
4. LABELING
Compiling and printing all labels.
The costs for the label material are not included.
5. QUALITY CONTROL
- QA according to RMS requirements
- quarterly environmental monitoring
- radio safety control
This does not include any costs for additional or re-validations.
6. LOGISTICS SUPPORT
- handling and storage of all deliveries
- arranging of all shipments
- maintaining a shipment tracking system
7. COMPLAINT HANDLING
- providing information of the particular product
- handling returned products
- testing returned products and generating a report
- disposal of returned products
8. WASTE DISPOSAL
Costs for handling and disposal of residual raw material and other
radioactive waste is included.
4