Exhibit 10.22
Portions redacted
* Certain information on this page has been
omitted and filed separately with the
Securities and Exchange Commission.
Confidential treatment has been requested
with respect to the omitted portions.
TECHNOLOGY TRANSFER AGREEMENT
Made this 6th day of August, 2002
BETWEEN
SHANXI WElQIDA PHARMACEUTICAL CO. LTD
SHANXI PROVINCE DATONG ECONOMIC AND TECHNOLOGY
DEVELOPMENT
AREA; P.R. 037300
CHINA hereinafter referred as `SW' which is a
company registered under the laws
of CHINA
AND
ALPHA PROCESS
TRUST REG.
IM ZIEL-430, POST FACR-146, MAUREN, FL 9493, LIECHENSTEIN
hereinafter
referred
as `AP' which is a company registered under
the laws of LIECHENSTEIN
1. PREAMBLE
1.1 SW is desirous to perform in his
pharmaceutical
plant (`Plant') in
China the fermentation of CLAVULANIC ACID and then the recovery of
the
POTASSIUM CLAVULANATE, CK, hereafter indicated as `Product'.
1.2 AP possesses the industrial
technology of "Product",
1.3 AP has agreed to supply to SW the
process know-how and
assistance to
realize the production at SW Plant of Product (as hereinafter
defined)
by using the latest processes AP possesses.
1.4 The parties therefore agree that AP sha1l supply such Know-how
including the Strain and technical assistance to SW on the
following
terms and conditions.
2. PRODUCTS AND PROCESSES
2.1 The products covered by this
Agreement are:
-
CLAVULANIC ACID by fermentation,
-
POTASSIUM CLAVULANATE,
CK. recovered from the fermentation broth
of CLAVULANIC ACID.
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2.2 The final Product, Potassium Clavulanate, CK, will comply with the
specification of Appendix 1.
2.3 The technical process of this
agreement includes:
A) Strain
preparation process:
- The
strains selection technology for stabilising the
production.
- All the
related information about the strains selection.
B) Fermentation
process:
- The
formulation
and raw material specification of each
culture media.
- Fermentation processes in
fermentors.
-
Steri1izatizon process, testing method, control and disposal
method.
C) Filtering
process
-
Pre-treatment and
filtering technology
of the fermentation
broth.
- The
filtering and
concentration method
of the fermentation
broth, optimized
filtering speed and the quality control of
filtered liquid.
D) Recovery
process
- The
specification and requirement of the extraction, and the
preparation of the extractive solvent.
- The
extraction control point
E) Refine and
crystallization
- Crystalization process
and control method.
- Drying
method and key operation points.
-
Milling-screening and package officia1 product.
F) Raw material
consumption:
- The
consumption of
fermentation and
recovery raw materials
for each Kilogram of product.
G) Quality
Control
- The
specification,
testing method and
analysis methods
of
the raw materials, intermediates and final product.
- Analysis
and analysis method of the fermentation both
composition and "in process".
H) Equipment
-
Production process flow diagram;
-
Equipment
specifications:
all, equipment
construction
drawings will be provided by the equipment suppliers.
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- If SW
needs, AP wi1l provide the detailed specifications and
sketches of
non-standard
equipment
(including
supplier
name).
- General
and preliminary layout of all buildings and all main
equipment main equipment; piping drawings will be prepare by
a local engineering company and, if requested by SW,
approved by AP.
- Relative
information
about the prefabricate equipment
(including suppliers name).
3. THE STRAIN
A. The Strain and its
process-know-how could
reach in fermentation about
* * * based on fermentation cycle of 90 / 100 hours.
B. The Extraction process can reach about * * * calculated as Kg of
Pottassium Clavulanate from * * * Kg-Activity in harvest broth.
4. TECHNOLOGY and SERVICES
PROVIDED BY AP
For the Product AP will provide.
A) Preliminary data of
economical evaluation of the know-how.
B) Detailed step-by-step
description of the
process in industrial plant,
including
Strains
maintenance,
block diagrams
and preliminary
flow-sheets of the process.
C) List and specifications of all equipment. Equipment construction
drawings will
be prepared by the relevant manufacturers with AP
technical assistance.
D) Assistance in equipment
procurement from different suppliers.
E) Analytical methods and
quality specification
for raw materials finish
products and intermediates.
F) Technical assistance and supervision during the production in
laboratory and pilot plant.
5. VERIFICATION TECHNICAL
PARAMETERS
In case that SW follows all AP's
instruction and
specification of
processes to
be supplied by AP under this Agreement, SW
shall obtain the following production
technical parameters:
5.1 Technical Parameters
A) Fermentation in * * * (net
fermentation cycle excluding discharge and
feeding of
fermentor): * * *.
*** CONFIDENTIAL MATERIAL REDACTED
AND SEPARATELY FILED WITH THE COMMISSION.
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Guaranteed
fermentation yield in* * * hours(net fermentation cycle); * *
*.
B) Extraction yield from
fermentation broth calculated as Kg of Potassium
Clavulanate (CK)
from * * * Kg
Activity in harvest broth: * * *
Guaranteed yield: * *
* Kg of CK from * * * Kg Activity of in harvest
broth.
C) Fermentors capacity
utilization ratio: 75%
5.2 The quality of Potassium
Clavulante,
CK, produced with AP's technology
shall
conform to US
Pharmacopoeia
The quantities of raw materials and
reagents
necessary for the
production of 1.00 kg of Potassium Clavulanate
are specified in
Appendix 2.
6. SERVICE TO BE PROVIDED BY
SW
SW will provide or perform
following services at no cost to AP.
A) Organize a project team with
a minimum number of
engineers,
chemists
and biologists which shall receive the process documentation
supplied
by AP. The number of the persons of the team may be increased
according to future requirement.
B) Purchase in due time all the equipment according to the lists
specifications and
relevant drawings of such equipment which shall be
supplied by AP.
Procure all relevant
services to finalize the design
regarding civil
engineering and
installation of the equipment. Such
design shall be based on the basic documentation and specifications
as
provided by AP under this Agreement.
C) Procure in due time all the
raw materials and reagents of the required
specifications for the
performance
of test runs and verification
batches.
D) Take all the necessary steps
in accordance with the specifications, to
be furnished by AP at
least 3 (three) months
in advance, so that
at
the various phases of the implementation of the project, the
personnel
which is required according to AP's recommendations, is available.
The
personnel referred to
