EXHIBIT 10.22
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SUPPLY AND DISTRIBUTION AGREEMENT
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1. PARTIES
This Agreement is made between
VIRAGEN INTERNATIONAL, INC. having its principal address at 000 XX
00xx Xxxxxx, Xxxxx 000, Xxxxxxxxxx, XX 00000 and VIRAGEN (SCOTLAND)
LTD. having its principal address at Pentland Science Park, Xxxx Loan,
Peniculk, Midlothian EH260 PPZ, UNITED KINGDOM,
hereinafter referred to as "the Company" and
HARVESTER TRADING CO., LTD., having its principal address at 000, Xxxx
Xxx X. Xxxx, Xxxxxx, Xxxxxx, R.O.C.
hereinafter referred to as "the Distributor".
2. PURPOSE
The purpose of this Agreement is to grant the Distributor the
exclusive right to market, sell and distribute the Product within the
Territory as defined in Exhibit A and in accordance with the terms and
conditions expressed herein.
3. DEFINITIONS
In this Agreement, each time the following terms are used with initial
capitals, their meanings shall be as specified hereunder.
. "Affiliated Companies" shall mean, in relation to a given
company, any company which, directly or indirectly, controls, is
controlled by or is under common control with such company.
. "Batch" and "Lot" shall mean a defined quantity of the Product
which has been produced during a defined cycle of manufacture,
and which is identified by a unique production number.
. "Contract Year" shall mean any period of l2 (twelve) consecutive
calendar months following the Effective Date, as defined
hereunder, or anniversary thereof.
. "Distribution Record" shall mean the record sheet detailing every
shipment of the Product made by the Distributor to any of its
customers including, but not limited to, the customer's name,
address, batch number, number of bottles and date of shipment.
. "Effective Date" shall mean the first day of the month following
the month during which the Distributor is granted the "Product
License", hereinafter "PL", as hereunder defined.
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. "Parties" shall mean the Company and the Distributor.
. "Party" shall mean either the Company or the Distributor.
. "PL" shall mean the Product License (or authorization under a
physician prescription/named patient program) granted by the
competent medical authorities of Taiwan for allowing the sale and
distribution of the Product in the Territory.
. "Price" shall mean the price of the Product as described in
Exhibit B.
. "Product" shall mean Multiferon(TM) as chemically described and
with the specification given in Exhibit C as modified from time
to time according to the provisions of Exhibit B.
. "Recall Operation" shall mean the operation for recalling the
Product if it is suspected or known to be defective.
4. APPOINTMENTS
The Company hereby appoints the Distributor as its exclusive
Distributor for the Product in the Territory (as defined in Exhibit A)
and Distributor hereby accepts such appointment in accordance with the
terms and conditions herein expressed.
5. PRODUCT PURCHASE AND SUPPLY COMMITMENTS
5.1 Distributor and Company agree to the purchase and supply of the
following U.S. Dollar purchase and sales of Product over the initial
term of this Agreement per the following Performance Schedule, subject
to the terms and conditions herein expressed:
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Performance Schedule
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Estimated
Purchase and
Sales in U.S.
Period Duration Dollars
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Initial Period First Consecutive 12 to 18 Months $ 233,800.00
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First Period Second Consecutive 12 to 18 Months $ 351,700.00
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Second Period Third Consecutive 12 Months $ 586,170.00
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Third Period Fourth Consecutive 12 Months $ 762,021.00
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Fourth Period Fifth Consecutive 12 Months $ 937,872.00
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Fifth Period Sixth Consecutive 12 Months $1,125,446.00
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Total $3,997,009.00
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* Fifth Period (and any portion thereof) is operative if less than 18
months is achieved in either the First and/or Second Periods.
5.2 Distributor will initiate a Registration Trial on Hepatitis C patients
immediately after receipt of initial shipment of Product. Distributor
will pay for all materials (including
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Product), costs and expenses incurred for clinical evaluations, except
for the Registration Trial, for which the Company will supply the
product, as indicated in Exhibit A
5.3 Company and Distributor will cooperate in a Pre-License program in
order to obtain sales during the pre-license period, under the
conditions established in Exhibit E. A sample seeding program will be
implemented, under the conditions established in Exhibit E.
6. MEDICAL REGISTRATION
6.1 The Distributor shall take any and all necessary measures in order to
obtain and maintain appropriate approvals from the Taiwanese
regulatory authorities which shall include, but not be limited to, a
PL and authorization to distribute the Product within Taiwan. All
costs and expenses associated with obtaining regulatory approval and
the necessary permits to sell the Product in the Territory shall be
borne by the Distributor (as described in Exhibit A).
6.2 If the PL is not obtained within eighteen (18) months from the date of
the last signature to this Agreement, Viragen shall have the right to
terminate the Agreement according to the conditions contained in
Article 11 below.
6.3 The Distributor shall pay all regulatory and governmental registration
fees, all the annual registration maintenance fees and other fees
required for the sale of the Product as promulgated by any local,
regional or national governmental authority.
6.4 In the event the Company is not free to disclose to the Distributor
any information required by the responsible regulatory or other
authorities, the Company shall be obliged to make such secret
information available to the authorities on the Distributor's behalf
at its own cost and expense.
6.5 The Company shall receive two (2) copies of all registration
certificates and any other data or documentation forthwith upon their
issuance. The Distributor specifically agrees to provide the Company
with copies of all correspondence with the registration authorities as
well as any and all government agencies. Each party shall furnish the
other with information on any observed unexpected side effects,
injury, toxicity or sensitivity reaction associated with the clinical
use, studies, investigations or tests of the Product in accordance
with Exhibit D, which contains a sub-agreement.
6.6 Distributor will at its own cost register the Product in Taiwan and
the Distributor will be the owner of the Registration in accordance
with the existing rules of the Taiwanese law. Harvester will complete
the Registration of the Product in Taiwan within eighteen (18) months
or earlier from the date of the last signature to this Agreement.
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7. COMPETITION, REPORTS, FORECASTS, INFORMATION AND INVENTORY
7.1 Obligation Not to Compete
The Company shall refrain from selling the Product in the Territory
and shall not grant nor appoint any other person or entity as
Distributor of the Product in the Territory.
The Distributor shall not manufacture, sell or distribute any other
interferon. The Distributor may, however, continue its business
activities with respect to such products as it sells or distributes on
the date of signing this agreement as reflected in Exhibit F. The
Distributor may nominate a Sub-Distributor upon submission of a
request for approval and a copy of the draft Sub-Distributor Agreement
which shall be submitted to the Company for its approval. No
Sub-Distributor agreement shall be valid without the written approval
of the Company.
From the date of this agreement, Distributor shall not distribute,
directly or indirectly, any products containing the same active
ingredients as the Product.
The Distributor hereby warrants that it shall not seek customers for
the Product outside the Territory, sell the Product outside the
Territory, or establish any branch or maintain any distribution depot
outside the Territory. The Sub-Distributor Agreement shall require the
Sub-Distributor to so warrant and the Distributor shall be accountable
to the Company for enforcing this provision.
The Distributor shall not have the right to produce the active
ingredient of the Product.
7.2 Reports and Agreements
The Distributor agrees to furnish the Company each calendar quarter,
or at such intervals as agreed upon by the Company and the
Distributor, with a true and accurate report on all sales of the
Product in the Territory, as specified herein. The Distributor agrees
to also furnish the Company with copies of all agreements, brochures,
pamphlets and documents which may relate to the Product including
those developed, produced or used by the Distributor in connection
with the sale of the Product. The Distributor agrees not to use any
such material without the Company's prior written approval. Upon
submission, the Company agrees to respond promptly without any
unnecessary delay and consent shall not be unreasonably withheld.
At any time upon reasonable request of the Company, Distributor agrees
to provide the Company with information, including but limited to,
selling prices, market trends, competitive environment and
competitor's prices, technical or commercial information useful for
the adaptation of the Product to market requirements. Distributor
agrees to send to the Company a quarterly report on market
developments in the Territory and Distributor's sales progress
relating to the Product.
At any time and upon reasonable request of the Company, Distributor
shall permit the Company's representative(s) to accompany
Distributor's representative(s) on visits made to customers in order
to have the Company better acquainted with the specificity of the
market for the Product in the Territory. The Company agrees not to
circumvent the Distributor during the term hereof and any renewal.
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7.3 Forecasts
Following PL approval, the Distributor shall submit to the Company
each calendar quarter during each calendar year a rolling forecast for
the following 4 (four) quarters showing the planned purchase
quantities of the Product. The Distributor shall place its firm orders
for the Product for the following quarter with the rolling forecast.
Before approval by the Company, the Distributor shall submit each
month a rolling forecast for the following twelve months connected to
firm orders for the Product for the following quarter.
7.4 Information
The Company shall provide the Distributor with all presently available
data, information and documents necessary for the carrying out of this
Agreement, including technical documents and advertising material.
7.5 Inventory
The Distributor shall buy and maintain, at his own cost, an inventory
of the Product equaling no less than the amount forecasted for the
following quarter and see to it that the Product is kept in good
condition and that all reasonable precautions are taken to prevent its
deterioration at its own cost, expense and liability.
8. THE DISTRIBUTOR
8.1 Independency
8.1.1 For Its Own Account
The Distributor shall buy and sell the Product in its own name and for
its own account and act in all respects as an independent contractor.
The Distributor shall organize the distribution of the Product in such
a manner as to most effectively promote the sale of the Product and
maintain a level of product support necessary for the proper selling,
marketing and distribution of the Product.
8.1.2 Independent Contractor
This Agreement does not designate the Distributor to be the agent,
partner or legal representative of the Company for any purpose
whatsoever, and the business con-ducted by the Distributor pursuant to
this Agreement with third parties shall be wholly at the Distributor's
own risk and account as an independent contractor.
The Distributor is not granted any right or authority to assume or
create any obligation or responsibility, express or implied, on behalf
of or in the name of the Company or to bind the Company in any manner
whatsoever.
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8.2 Unfair Competition and Infringement of Rights
The Distributor shall inform the Company of all acts of unfair
competition and of all infringement of patents, trade xxxx, trade
names, or similar rights of the Company which have come to its
attention to the extent that the rights of the Company have been
violated. If requested by the Company, the Distributor shall assist
the Company at the Company's expense in any action or litigation
involving such acts or infringements.
8.3 Distribution Records
In order to enable the Company to comply with the requirements of the
European Code of Good Manufacturing Practice (Volume IV of the Rules
Governing Medical Products in the European Community), the Distributor
shall keep Distribution Records for each Batch of the Product sold to
the customers. This information shall be made available to the Company
in case of Recall Operation or upon request, within two working days,
by sending a fax, confirmed by a letter, to:
ViraNative AB Viragen (Scotland) LTD.
Tvistevagen 48 Pentland Science Park
S-907 00 Xxxx Xxxx Xxxx, Xxxxxxxx
Sweden Midlothian EH260 PPZ
United Kingdom
Tel.: 00-00-000000 Tel.: 00-000-000-0000
Fax: 00-00-000000 Fax: 00-000-000-0000
9. CONDITIONS OF SALE
9.1 Purchase Orders
The Distributor shall present all orders for the Product to be
purchased under this Agreement to the Company together with adequate
delivery instructions and pre-payment. Orders presented by the
Distributor shall bind the Company only after written confirmation of
acceptance thereof by the Company. The Company will deliver the
Product to the Distributor within two (2) months after a firm Purchase
Order is successfully placed by the Distributor.
9.2 Price Guidelines
9.2.1 Price and Conditions
The Distributor shall purchase the Product at prices and on conditions
set forth by the Company from time to time in Exhibit B.
Notwithstanding the above, the Company shall be entitled to change any
Product Price due to changes in raw material, market environment,
competitive situations or other situations six (6) months after a new
price agreement has been reached between both parties..
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9.2.2 Payment Terms
The Distributor shall pay the Company for the Product supplied
according to payment terms as set forth in Exhibit B.
9.3 Advertising and Promotion
9.3.1 Best Efforts
The Distributor shall use its best efforts and diligence in promoting
and initiating effectively the sales of the Product throughout the
whole of its Territory.
9.3.2 Advertising and Promotional Activities
The Distributor shall ensure the advertising and the promotion of the
Product and, to a reasonable extent, the participation in conventions,
trade shows and exhibitions held in the Territory. The costs of
advertising and promotion are to be borne by the Distributor. All
advertising and promotional copy shall be submitted to the Company for
its written approval prior to release.
9.3.3 Conformity with Applicable Laws
9.3.4 The Distributor shall be responsible for any advertising and
promotional material for the Product and for their conformity with
applicable laws and regulations.
9.3.5 Thirty (30) days before the first delivery takes place; Distributor
shall provide the Company with the art works of:
. the carton
. the labels for the Product and the cardboard box per the models
communicated by the Company to the Distributor, and the leaflets
to be packed with the Product
all of which shall be approved by the Company.
9.3.6 Before approval, the Company will deliver the Product in ampoules of 3
and 6 MIU, labeled with English text indicating batch numbers and
expiration date, packed in plastic trays, each containing five
ampoules.
9.3.7 Distributor shall be responsible for delivering copy of any text in
Chinese that may be required under law, rule or regulation.
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10. GENERAL PROVISIONS
10.1 Trade Secrets
Both parties shall not, even after the expiration of this Agreement,
use or communicate to any third party any trade secrets which either
party has come to know in one way or another through its work for the
other party. The obligation shall cease at the end of a period of
(five) 5 years from the date of the termination or expiration of this
Agreement; however, the obligation shall not cease for any reason
prior to the end of the first (ten) 10 years after the signing of the
Agreement.
The Distributor assumes the responsibility, liability and obligations
that its employees and any Sub-Distributor and its employees shall
preserve the secrecy of trade secrets with respect to third parties.
10.2 Trademarks
Trademarks, Tradenames and Copyrights used by the Distributor for the
Product shall be the property of the Company, and the Distributor
agrees to use only such Trademarks, Tradenames and Copyrights as
indicated and approved in writing by the Company. It is agreed that
the Company's registered trademark of the Product, Multiferon(TM) may
be used in Taiwan, provided a registration of these trademarks will be
obtainable and maintained.
The Distributor shall not, without the Company's prior written
consent, use the Company's corporate name, telegraphic address,
graphic or other trademarks, whether during the maintenance of or
after the termination of this Agreement.
The Distributor shall not register or attempt to register for any
purpose any trade-xxxx, tradename, copyright, name, title or
expression of the Company as used on the Product or any other
trademark or any tradename which is similar thereto.
Electronic emails may be considered adequate consent if originated at
the Company's premises.
Neither party shall be liable to compensate the other party for any
claims, expenses, costs, losses or damages either party may suffer as
a result of the infringement of any third party intellectual property
rights in connection with the transactions contemplated hereunder.
10.3 Assignment
The Company shall have the right to assign this Agreement, upon
written notice to Distributor but without the prior consent of
Distributor, to:
a) any of its Affiliated Companies; or
b) its successors in interest as a result of a statutory merger or
consolidation; or
c) a company acquiring all or substantially all of the Company's
business and assets including the part concerned by this
Agreement.
The Company reserves the right to terminate this Agreement whenever
the control of the Distributor's company passes over to another party
than the party controlling it at
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the time of signature of this present Agreement. Exhibit G lists the
current stockholders of the Distributor and its affiliates.
10.4 Force Majeure
If due performance of this Agreement by either party is affected in
whole or in part by reason of any event, omission, accident, general
shortage of commodities, legal circumstances or other matter beyond
the reasonable control of such party, it shall give prompt notice
thereof to the other party and shall be under no liability for any
loss, damage, injury or expense suffered by the other party for this
reason. Both parties shall use all reasonable efforts to avoid or
overcome the causes affecting performance and the party whose
performance is affected by such force majeure shall fulfill all
outstanding obligations as soon as possible.
10.5 Warranties and Liability
10.5.1 The Company warrants to the Distributor that the Product delivered
hereunder shall comply with the specification set forth in the Product
License and consistent with Exhibit C.
a) If the parties agree that a certain lot of the Product supplied
hereunder fails to meet said specification or is otherwise
defective or if such lot is recognized as defective by an
independent laboratory as provided for hereafter in this section,
and unless otherwise mutually agreed upon, the Distributor shall
send such lot back to the Company and the Company shall replace
it at its own expense, including the freight back, with a new lot
of the Product conforming with said specification. The
Distributor shall have no other remedies against the Company for
defects in the Product.
b) If the parties fail to agree that a certain lot of the Product
supplied hereunder meets said specification, Distributor may
request an expert appraisal by an independent laboratory, not
associated with any of the parties hereto, to determine whether
the Product complies with said specification. Should the Company
disagree with regard to the choice of laboratory, the Company has
the right to request that the laboratory is appointed by the
International Chamber of Commerce provided that the Company
informs the Distributor within two weeks after having been
informed by the Distributor about its choice of laboratory, that
the Company requests that the appraisal shall be carried out by a
laboratory appointed by the Chamber. The report of the laboratory
shall be conclusive and binding on the parties hereto. All
expenses related to such appraisal shall be borne by the party,
whose opinion of which has been found not to be correct.
No other warranties, expressed or implied, including, without
limitation, merchantability or fitness for a particular purpose,
are made or will be deemed to have been made by the Company
regarding the Products, except to the extent expressly stated
herein. Neither the Distributor, nor any of its employees, agents
or representatives is authorized to give any warranties or make
any representations on behalf of the Company. In no event shall
either party be held liable for any lost profits or any other
incidental or consequential damages in
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connection with any claims arising out of or related to any
products supplied by the Company to the Distributor.
10.5.2 The Distributor shall indemnify and hold the Company harmless from and
against any and all liability, damage, loss, cost or expense arising
out of or resulting from any claims made or suits brought against the
Company or the Distributor, which arise out of or result from the
Distributor's negligent act or omission in the marketing, selling or
distribution of the Product.
10.5.3 The Distributor asserts that the Taiwanese Government allocates a fund
to cover all and any risks, including (without limitation) any
liabilities to third parties and the public (including without
limitation product liability).
10.5.4 The Company represents that it will add the Distributor as a Named
Insured on its current International Liability Insurance Policy held
with MedMarc Casualty and Insurance Company under Policy Number
00FL020010 within 30 days from the date of execution of this
agreement.
10.5.5 Compliance with Applicable Laws
The Distributor agrees that it will, on its own comply with all laws,
statutes and ordinance in the Territory relating to the import and
sale of the Product and agrees to indemnify and hold the Company
harmless in the event that any claim is made against it by reason of
the Distributor's failure to so comply. In particular, the Distributor
agrees to comply with all safety laws and regulations in the Territory
relating to the Product and the Company agrees to provide all
necessary information and assistance to the Distributor to enable it
to so comply.
10.6 Taxes
The Distributor shall pay all excise or sales taxes that may be
required to be paid by the Company or the Distributor by any statute,
ordinance or regulation of any taxation authority. In the event that
the Company is required to or does pay any of such taxes, the
Distributor, upon being informed of such payment, shall at once repay
the amount thereof to the Company. The Distributor, unless prohibited
by any such statute, ordinance or regulation, shall have the right to
require any dealer or Sub-Distributor handling such goods to pay any
such excise or sales taxes on the goods so handled by him.
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11. DURATION AND TERMINATION
11.1 Duration
This Agreement shall have immediate force and effect and shall remain
in effect until the completion of the Fifth Period described in
Paragraph 5.1 of this Agreement and shall continue thereafter for an
additional three (3) year term and continue thereafter for two
automatic three (3) year terms unless and until terminated by either
party giving to the other six (6) months notice in writing prior to
the end of the Initial Term or any Subsequent Term.
11.2 Termination
11.2.1 Failure to Fulfill Obligations or to Obtain or Maintain PL
This Agreement may be terminated with three (3) months written notice
forthwith by either party if the other party fails to fulfill any of
its obligations under this Agreement and such default is not remedied
within thirty (30) days of the date on which a written notice thereof
has been dispatched to the defaulting party or if the Distributor
fails to obtain or maintain the PL as set forth in Article 6, Medical
Registration, unless such failure is attributable to the Company
11.2.2 Termination for Bankruptcy or Insolvency
This Agreement may be terminated immediately in the event that either
party is declared insolvent, is adjudged bankrupt or files a petition
for bankruptcy or re-organization under any bankruptcy law, is
expropriated or sequestrated or submits or has to submit to any other
administrative or judicial measures of control.
Insolvency is defined to mean the inability to pay debts, as they
become due and the excess of liabilities over assets.
11.2.3 Termination for Loss of License to Sell Product
The Company shall have a right to terminate this Agreement with
immediate effect should the Company's license to sell the Product be
withdrawn.
11.3 Effect of Termination
On the termination of this agreement, the Distributor shall return,
without delay, all registration and permission documents to the
Company together with all formulas, manufacturing procedures and other
confidential documentation which the Distributor has obtained from the
Company. The Distributor agrees that it shall not make any further use
of this documentation. The Company shall have the option to repurchase
any paid unsold Product at prices paid by the Distributor to the
Company.
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11.4 Notice of Termination
Provided that notice of termination has been dispatched by registered
letter, the notice shall be considered to have been received by the
addressee four days after the letter was so dispatched.
11.5 Exclusive Distribution Rights
In the event Distributor fails to achieve one-half (50%) of the sales
figures set forth under "Performance Standards" in paragraph 5.1, then
the exclusive distribution rights as set forth herein may be cancelled
in the Company's sole discretion. Distributor shall remain the
exclusive distributor within the Territory during the term of this
agreement and any renewal thereof in the event Distributor has
generated one-half or more of the sales figures set forth under
Performance Standards in paragraph 5.1. This provision shall not apply
during the first 18 months of the term of this Agreement and sales
shall be calculated on a 12-month basis thereafter.
11.6 Termination Compensation
Neither party hereto shall be liable to the other for any termination
compensation whether based on goodwill, loss of income or otherwise.
12. FINAL PROVISIONS
12.1 Governing Law
This Agreement shall be governed by the laws of a neutral country, to
be approved by both parties.
12.2 Language
The English text of this Agreement shall prevail.
12.3 Arbitration
Any dispute in connection with this agreement shall be finally settled
by arbitration in accordance with the Rules of the Arbitration Act of
the International Chamber of Commerce and the settlement will take
place in Edinburgh, Scotland and be conducted in the English language.
12.4 Modifications
All modifications and amendments to this Agreement shall be in
writing.
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12.5 Notices and Communications
All notices in connection with this Agreement shall be in writing and
be in the English language, as shall all other written communications
and correspondence, and may be given by personal delivery, prepaid
registered airmail letter, telecopier, or telegram addressed to the
Party required or entitled to receive the same at its address or
telefax number set out below, or to such other address or telefax
number as such Party shall have designated by like notice to the other
Party. Notice of termination of this Agreement if given by telecopier
or telegram shall be confirmed by prepaid registered airmail letter
dated and posted within 24 hours. The effective date of any notice if
served by personal delivery, telecopier, or telegram shall be deemed
the first business day in the city of destination following the
dispatch and if given by prepaid registered airmail letter only, it
shall be deemed served seven days after the date of posting.
12.6 Exhibits
All Exhibits attached hereto shall be made a part of this Agreement.
12.7 No Waiver
The omission by either Party to exercise any right hereunder shall not
constitute a waiver thereof and shall not prevent the subsequent
enforcement of that right and shall not be deemed to be a waiver of
any subsequent right.
12.8 Survival of Provisions
The provisions of this Agreement shall survive its termination for so
long as may be necessary to give efficacy thereto.
12.9 Entire Agreement
This Agreement, which includes the Exhibits attached hereto, contains
the entire understanding and supersedes all prior agreements of the
parties with respect to the transactions contemplated hereby. There
are no agreements, promises, warranties, covenants or understandings
other than those expressly set forth herein.
12.10 Invalidity
Any provision of this Agreement that is invalid or unenforceable in
any jurisdiction shall, as to such jurisdiction, be ineffective to the
extent of such invalidity or unenforceability without invalidating the
remaining provisions hereof or affecting the validity or
enforceability of such provision in any other jurisdiction.
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IN WITNESS WHEREOF the parties hereto have hereunto set their hands the day and
year indicated below.
By: /s/ Xxxxxx Xxxxx
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Xxxxxx Xxxxx
Chief Executive Officer
Viragen International, Inc.
September 20, 2002
By: /s/ Xxxxxx Xxxxx
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Xxxxxx Xxxxx
Chairman
Viragen (Scotland) LTD.
September 20, 2002
By: /s/ Xxxx Xxxxx
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Xxxx Xxxxx
Vice President
Harvester Trading Co., LTD.
August 15, 2002
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