Exhiibit 10.1
HDF-CARTRIDGE LICENSE AGREEMENT
This Agreement is entered into as of the 2nd day of March, 2005 (hereinafter
called "Effective Date") by and between Nephros, Inc., a Delaware corporation
with an office and place of business at 0000 Xxxxxxxx, Xxx Xxxx, XX 00000
(hereinafter called "Nephros") and Asahi Kasei Medical Co., Ltd., a Japanese
corporation with an office and place of business at 9-1, Xxxxx Xxxxxxxxxxxx,
Xxxxxxx-xx, Xxxxx 000-0000, Xxxxx (hereinafter called "Asahi").
WITNESSETH:
WHEREAS, Nephros represents that it owns certain intellectual property rights
covering certain technology relating to the mid-dilution hemodiafiltration;
WHEREAS, Nephros and Asahi entered into the "CONFIDENTIALITY AGREEMENT" dated 14
September, 2004 for evaluating the possibility of entering into a license
agreement on such technology; and
WHEREAS, as a result of such evaluation, Asahi desires to obtain and Nephros is
willing to grant, such license;
NOW, THEREFORE, in consideration of the mutual covenants and obligations assumed
by the parties hereto, Nephros and Asahi agree as follows:
Article 1. Definitions
----------------------
For the purposes of this Agreement, the following words and phrases shall have
the meanings as shown:
1.1 "Licensed Technology" shall mean the technology relating to a cartridge of
single filter type for mid-dilution hemodiafiltration, including without
limitation the technology relating to a use of such cartridge in a
hemodialysis/hemodiafiltration system. It is confirmed that the technology
relating to substitution fluid filter OLpur(TM) H2H(TM) shall not be
included in the Licensed Technology.
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1.2 "Licensed Patents" shall mean (i) all the Japanese patent applications
listed in Exhibit 1, and (ii) any Japanese patent application on their
improvement or modification, and their issued patents and divisions
thereof, which Nephros as of the Effective Date and during the term of this
Agreement owns or controls, or under which Nephros as of the Effective Date
and during the term of this Agreement shall have the right to grant a
sublicense, to the extent covering the Licensed Technology.
1.3 "Licensed Key Patent" shall mean the Japanese patent application listed as
the "key patent" in Exhibit 1 and its issued patent and divisions thereof,
which Nephros as of the Effective Date owns or controls, to the extent
covering the Licensed Technology.
1.4 "Know-How" shall mean all information and improvement or modification in
the possession of Nephros as of the Effective Date and during the term of
this Agreement, whether or not patentable, constituting materials, methods,
processes, techniques and data for the Licensed Technology, which Nephros
is free to transfer or disclose without violating existing contractual
obligations to third parties including, without limitation, marketing
strategies and promotional plans. It is confirmed that the technical
matters or items listed in Exhibit 2 shall be included in Know-How.
1.5 "Licensed Cartridges" shall mean the mid-dilution hemodiafiltration
cartridges based on the Licensed Technology.
1.6 "Payment Cartridges" shall mean the mid-dilution hemodiafiltration
cartridges of the Licensed Cartridges, which are encompassed within the
scope of the issued claims of the Licensed Patents as long as the Licensed
Key Patent remains in effect.
1.7 "Invalid" shall mean that a decision or judgment that all claims contained
within the Licensed Key Patent are invalid or nullified is final and
conclusive.
1.8 "Territory" shall mean the geographical country of Japan.
1.9 "MOH" shall mean Ministry of Health, Labor and Welfare of Japan.
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1.10 "Net Sales" shall mean the prices billed by Asahi to the customer of the
Payment Cartridges which are manufactured or had manufactured and sold by
Asahi in the Territory, less (i) transportation and insurance charges or
allowances, if any included in such price; (ii) discounts allowed, and
commissions paid in lieu of trade discounts in amounts customary in the
trade; (iii) credits and allowances, if any, given or made on account of
the return or rejection of the Payment Cartridges previously delivered or
retroactive price reductions, (iv) tax or other governmental charge on
sale, transportation or delivery of such Payment Cartridges which is borne
by Asahi and (v) the cost of packaging materials of such Payment
Cartridges.
1.11 "Government Approval Date" shall mean the date of approval by the MOH set
forth in Article 4.1.
Article 2. Grant of License
---------------------------
2.1 Exclusive License
Nephros hereby grants Asahi an exclusive right and license under the
Licensed Patents and Know-How (including that disclosed by Nephros under
Article 3) to practice or use the Licensed Technology, including without
limitation to manufacture, have manufactured, use, market, distribute and
sell the Licensed Cartridges within the Territory and to have the Licensed
Cartridges manufactured by Asahi's subsidiary in the People's Republic of
China for Asahi's sale in the Territory. Asahi agrees to indemnify Nephros
for direct damages to the Licensed Technology of Nephros arising from the
manufacture of Licensed Cartridges in the People's Republic of China.
The term "Asahi's subsidiary" shall mean any corporation or legal entity of
which Asahi owns and will own directly or indirectly fifty percent (50%) or
more of the issued and outstanding capital stock having the right to vote
for the election of directors.
During the term of this Agreement, Nephros may not exercise or use such
right or license in the Territory.
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2.2 Non-Assertion
Nephros shall not assert any infringement claims with respect to the
Licensed Patents or Know-How against Asahi's customers or users in the
Territory.
2.3 Right of First Negotiation
Before Nephros negotiates with any third party to grant an option or
license under its patents and know-how to practice or use the Licensed
Technology in any geographical countries of the People's Republic of China,
the Republic of Korea (South Korea), Taiwan, Thailand, India, Malaysia, the
Philippines, Singapore, Nephros shall offer in writing and negotiate in
good faith with Asahi to grant such license. If an agreement of such
license in a geographical country is not reached by the parties within
ninety (90) days after commencement date of negotiation, Nephros may
negotiate with such third party to grant such license in such geographical
country.
Article 3. Disclosure of Know-How and Asahi's Improvement
---------------------------------------------------------
3.1 Within ninety (90) days after the Effective Date, Nephros shall disclose to
Asahi all Know-How owned by Nephros as of the Effective Date.
3.2 If Nephros develops or obtains any of the Know-How and the Licensed Patents
during the term of this Agreement, Nephros discloses to Asahi the same.
3.3 If Asahi develops or obtains any improvement or modification to the
Licensed Technology during the term of this Agreement, Asahi may at its
discretion disclose to Nephros such improvement or modification. If Nephros
requests Asahi to obtain a license of such improvement or modification,
Asahi shall, for at least a 90 day period, negotiate with Nephros to grant
such license in countries to be negotiated.
Article 4. Approval and Cooperation
-----------------------------------
4.1 When Asahi conducts preclinical and clinical trial(s) of the Licensed
Cartridges and makes all regulatory submissions necessary for the approval
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by the MOH with respect to the right to market the Licensed Cartridges in
Japan, Nephros shall at the request of Asahi cooperate with Asahi for such
trial(s) and regulatory submissions. Such cooperation shall include
providing Asahi with data of preclinical and clinical trials in the U.S.A
as well as other countries.
Article 5. Investment and Consideration
---------------------------------------
5.1 Investment
Within fourteen (14) days after the Effective Date, Asahi shall conclude an
investment in newly issued common stock of Nephros as described in Schedule
1.
5.2 Initial License Fee
In consideration of the right and license granted to Asahi hereunder, Asahi
shall pay to Nephros the initial license fee set forth in Schedule 2.
5.3 Milestone Payment
In consideration of the right and license granted to Asahi (including
non-assertion) hereunder, Asahi shall pay to Nephros the milestone payments
set forth in Schedule 3.
It is confirmed that Asahi shall not be required to make any milestone
payment set forth in this Article 5.3 during the term of this Agreement
after the Licensed Key Patent becomes Invalid or expires.
5.4 Royalty
5.4.1 Running Royalty
In consideration of the right and license granted to Asahi (including
non-assertion) hereunder, Asahi shall pay to Nephros the running royalty
equal to the percentage of the Net Sales as set forth in Schedule 4 in each
fiscal year of Asahi (hereinafter called "Fiscal Year") within sixty (60)
days after the end of such Fiscal Year.
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5.4.2 Minimum Sales Volumes
The minimum volumes of sales of the Payment Cartridges by Asahi in the
Territory shall be as set forth in Schedule 5 and shall be adjusted to each
Fiscal Year by both parties in writing after the Government Approval Date.
If the actual volumes of sales of the Payment Cartridges in a Fiscal Year
are less than the minimum volumes thereof, Asahi pays, instead of the
running royalty set forth in Article 5.4.1 and unless the Licensed Key
Patent becomes Invalid or expires, the minimum royalty equal to the
applicable percentage (set forth in Article 5.4.1) of the amount calculated
by multiplying the minimum volume by the average of the Net Sales in such
Fiscal Year.
5.4.3 Royalty Payment
The payment of the running royalty or the minimum royalty set forth in
Article 5.4.1 or 5.4.2 shall be made paid in US dollars. The amounts due
shall be calculated in Japanese Yen (hereinafter called JY") and then
converted into USD at the Telegraphic Transfer Selling (TTS) exchange rate
as quoted and published by the Bank of Mitsui-Sumitomo (or such other
source as agreed to by the parties from time to time) as of the last
business day of the Fiscal Year for which such payment is due.
It is confirmed that Asahi shall not be required to make any payment set
forth in Articles 5.4.1 and 5.4.2 during the term of this Agreement if the
Licensed Key Patent becomes Invalid or expires.
5.4.4 Report
Asahi shall make written reports on the running royalty set forth in
Article 5.4.1 semi-annually within sixty (60) days after the first day of
April and October of each year, stating the type of the Payment Cartridges
sold, the quantity of each type and the total Net Sales of each type sold,
and expressed in JY, during the period as to such payment. Within sixty
(60) days after the first day of July and January of each year, Asahi shall
provide an estimate of the sales for the preceding three months.
5.4.5 Records
Asahi shall keep adequate and complete records of the Payment Cartridges
sold with respect to which the running royalty payment is due by Asahi
hereunder for three (3) years after such payment. Such records shall
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include all information necessary to verify the total amount and
computation of such payment due Nephros hereunder, and shall, at the
request of Nephros, with respect to any year ending not more than two (2)
years prior to the date of such request, be open to inspection by Nephros
during reasonable business hours to the extent necessary to verify the
amount thereof. Such inspection shall be made not more than once each
Fiscal Year of Asahi at the expense of Nephros by a Certificate Public
Accountant appointed by Nephros and consented to by Asahi.
5.5 Remittance
All payments made by Asahi to Nephros pursuant to Articles 5.1 through 5.4
shall be made in USD by telegraphic transfer to the account of Nephros at a
bank to be designated in writing by Nephros.
5.6 Withholding Tax
All payments made by Asahi to Nephros pursuant to Articles 5.2 through 5.4
shall be made free of any and all taxes of a country of the Territory as
imposed on such payments. Notwithstanding the above, Asahi may deduct from
such payments any and all withholding taxes paid by Asahi to such country's
tax authorities. Upon such deduction, Asahi shall supply certificates to
Nephros immediately upon receipt thereof.
Article 6. Licensed Patents
---------------------------
6.1 Nephros shall, through its own patent attorney and at its own cost and
expense, cause to be filed and prosecuted the Licensed Patents and all
future Licensed Patents which lend protection to the Licensed Cartridges in
the Territory. Nephros agrees to exercise all reasonable efforts to cause
such Licensed Patents to be prosecuted and all Licensed Patents issued in
respect thereof to be maintained in such manner that the best possible
patent protection may be obtained thereon, provided that (i) Nephros shall,
in advance, consult Asahi on the steps for the filing, prosecution and/or
maintenance of any Licensed Patents in the relevant patent office in the
Territory and take such steps fully considering Asahi's opinion and (ii)
Nephros shall keep Asahi promptly and fully informed of the course of the
filing, prosecution and/or maintenance of any Licensed Patents in the
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Territory by providing Asahi with copies of communications between Nephros
and the relevant patent office in the Territory.
6.2 The Grant of Exclusive License on the Licensed Key Patent Whenever the
Licensed Key Patent is issued in Japan, Asahi shall, in the name of Nephros
but at Asahi's own cost and expense, have the right to have the grant of
the Exclusive License set forth in article 77 of Japanese Patent Law on the
Licensed Key Patent registered with the Japanese Patent Office and Nephros
shall cooperate with Asahi to register the grant of the Exclusive License
on the Licensed Key Patent.
The term "Exclusive License" shall mean "SENYO JISSIKEN" set forth in
article 77 of the Japanese Patent Law, the grant, transfer (except those by
inheritance or other general succession), modification or extinguishment
(except those resulting from a merger or the extinguishment of the patent
right) of which, or a restriction on the disposal thereof shall be of no
effect unless they are registered. Asahi will, at its cost, follow the
necessary procedures to cancel the registration upon termination or
cancellation of this Agreement pursuant to Article 8.2.3 or 8.3.
6.3 Infringement of Licensed Patents
In the event that either party shall become aware that any Licensed Patent
is being infringed by a third party, such party shall notify the other of
the facts in respect thereof.
Asahi shall have the first right to enforce the Licensed Patents against
such infringer in the name of Asahi, in the name of Nephros or in both
their names. Nephros shall cooperate with Asahi as reasonably requested by
Asahi in taking any such actions against such infringer.
Asahi shall be entitled to all amounts recovered as a result or consequence
of such actions up to the total amount of (i) the costs and expenses
(including attorney's fee) incurred by Asahi in such actions and (ii) the
running royalty paid by Asahi to Nephros hereunder.
If Asahi does not take such action within ninety (90) days after the
receipt of written notice from Nephros requiring Asahi to take such action,
Nephros shall be entitled to enforce the Licensed Patents against such
infringer at its own cost and shall be entitled to all amounts recovered as
a result or consequence of such actions.
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Article 7 Representation, Warranty and Indemnification
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7.1 Representation and Warranty
7.1.1 Nephros represents and warrants that (i) it is and will during the term of
Agreement be the sole and exclusive owner of the Licensed Patents and
Know-How to the extent required for granting the right and license
contained herein; and (ii) it has full power, right and authority to grant
the right and license contained herein.
7.1.2 Asahi represents and warrants that it has full power, right and authority
to enter into and carry out its obligations under this Agreement.
7.2 Disclaimer of Warranties; No Liability
UNLESS EXPRESSLY OTHERWISE SET FORTH HEREIN, EITHER PARTY ("DISCLAIMING
PARTY") SHALL NOT BE LIABLE FOR ANY LOSS OR DAMAGE ARISING OUT OF OR
RESULTING FROM THE EXERCISE BY THE DISCLAIMING PARTY OF ANY RIGHT AND
LICENSE GRANTED HEREUNDER, OR BE LIABLE TO THE OTHER PARTY FOR ANY
CONSEQUENTIAL DAMAGES UNDER ANY CIRCUMSTANCES, EXCEPT IN CASE THAT SUCH
LOSS OR DAMAGE ARISES OUT OF THE GROSS NEGLIGENCE OR WILLFUL ACT OF THE
DISCLAIMING PARTY.
NEPHROS HAS NO RESPONSIBILITY FOR CLAIMS OF PRODUCT LIABILITY ON THE
LICENSED CARTRIDGES MANUFACTURED BY ASAHI HEREUNDER.
7.3 Third Party's Right
Nephros agrees (i) to defend any and all claims, actions and suits alleging
that the manufacture, having manufactured, use or sale of the Licensed
Cartridges by Asahi in the Territory infringes any patent or other
intellectual property right of any third party during the term of this
Agreement, except to the extent such claims, actions and suits arise out of
material modifications made by Asahi to the Licensed Technology or material
breach hereof by Asahi; and (ii) to hold Asahi harmless from all loss,
damage, expense and
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liability on account of any such infringement, provided that Nephros shall
have prompt notice of the commencement of any such action or suit and full
opportunity to defend the same. Asahi shall, at its expense, be entitled to
participate in the defense of any such, claim action or suit through
counsel selected by it.
Article 8. Term and Termination
-------------------------------
8.1 This Agreement shall be effective on the Effective Date and shall, unless
earlier terminated or cancelled under Articles 8.2 or 8.3 below, remain in
full force and effect for ten (10) years period from the Government
Approval Date. Provided, however, that after such ten year period, Asahi
has the right to retain the right and license granted to Asahi hereunder:
(a) With the obligation to pay to Nephros the running royalty as set forth
in Schedule 4 until and as long as the Licensed Key Patent remains in
effect or until it becomes Invalid; and
(b) Without any obligation to pay to Nephros any royalty or other
consideration after the Licensed Key Patent expires or it becomes
Invalid; or
(c) Without any obligation to pay to Nephros any royalty or other
consideration if the Licensed Key Patent has expired or becomes
Invalid on or before such ten year period.
8.2 Termination
8.2.1 One party ("terminating party") shall have the right to terminate this
Agreement, in the event that:
(a) the other party fails to fulfill its obligations hereunder and that
such failure is not remedied within ninety (90) days after the other
party's receipt of written notice from the terminating party; or
(b) the other party ("liquidating party") goes into liquidation, or seeks
the benefit of any bankruptcy or insolvency act, or a receiver or
trustee is appointed for the property or estate of the liquidating
party, or the liquidating party makes an assignment for the benefit of
creditors, and whether any of the aforesaid events be the outcome of
the voluntary act of the liquidating party or otherwise.
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8.2.2 The termination of this Agreement shall be without prejudice to the
terminating party's right to receive all payments accrued and unpaid
hereunder at the effective date of such termination as to periods prior to
termination and to the remedy of the terminating party in respect of any
previous breach of any of the covenants herein contained.
8.2.3 Upon termination of this Agreement by Nephros, Asahi shall have no right
to manufacture or have manufactured and market the Licensed Cartridges
except that Asahi may dispose of inventory on hand. Upon termination of
this Agreement by Asahi, Asahi shall retain the right and licenses granted
to Asahi hereunder without any payment to Nephros after such termination.
8.3 Cancellation
If it becomes impossible or unreasonably difficult to (i) obtain the
approval by the MOH set forth in Article 4.1 or (ii) manufacture or sell
the Licensed Cartridges due to a reason not attributable to Asahi, Asahi
has the right to cancel this Agreement during the term of this Agreement
upon ninety (90) days written notice to Nephros. Upon cancellation of this
Agreement, Asahi shall have no right to manufacture or have manufactured
and market the Licensed Cartridges except that Asahi may dispose of
inventory on hand. Cancellation of this Agreement for any reason shall not
relieve Asahi of the obligation to pay, if any, all fees, payments and
royalties then due up to the date of such cancellation.
Article 9. General
------------------
9.1 Force Majeure
Neither party to this Agreement shall be liable for any delay or failure of
performance that is the result of any happening or event that could not
reasonably have been avoided or that is otherwise beyond its control. Such
happenings or events shall include, but not be limited to: fire, flood,
explosion, action of the elements, inability to obtain or shortage of
material, equipment or transportation, governmental orders, regulations,
restrictions, priorities or rationing, acts of God, accidents and strikes,
lockouts or other labor trouble or shortage.
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9.2 Confidentiality
During the term of this Agreement and for a period of five (5) years
thereafter or for ten (10) years after the effective date hereof, whichever
is longer, each party agrees to keep confidential and not to disclose to
any third party the Confidential Information (as defined below), except to
the extent necessary for the commercialization of the Licensed Cartridge
and for the purpose of performance of this Agreement.
The term "Confidential Information" shall mean all technical and economic
information relating to the Licensed Technology, including without
limitation Licensed Patents, Know-How and Asahi's improvements thereto,
which is furnished by the disclosing party to the receiving party and which
is marked or otherwise identified by the disclosing party as
"Confidential". If Confidential Information is disclosed between the
parties in oral or other intangible form, the disclosing party shall
thereafter summarize it in writing and transmit it to the receiving party
within thirty (30) days from such disclosure. From Confidential Information
shall be excluded any information which the receiving party can demonstrate
by written records:
(a) Was already in the receiving party's possession or control prior to
the date of disclosure; or
(b) Was on the date of disclosure to the receiving party in or thereafter
enters the public domain other than as a result of disclosure by it in
breach of this Agreement; or
(c) Becomes available to the receiving party on a non-confidential basis
from a source other than the disclosing party, provided that such
source has the right to disclose such information and is not
prohibited by a confidentiality agreement with or other contractual,
legal or fiduciary obligation of nondisclosure to the disclosing party
or to another third party; or
(d) Is independently developed by the receiving party without any breach
of this Agreement.
Notwithstanding the foregoing, a party shall be entitled to disclose the
Confidential Information if required in legal proceedings; provided that
the disclosing party shall provide the other party with prompt notice of
any such requirement so that the other party may seek a protective order or
other appropriate remedy and/or waive compliance with the provisions of
this
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Agreement, and that the disclosing party shall disclose only that portion
of the Confidential Information which is legally required to be disclosed.
9.3 Press Release
Neither party may issue any press release or make any public announcement
concerning the transactions contemplated by this Agreement and the
existence of this Agreement without the prior written consent of the other
party, except as required by law.
9.4 Notices
Any notices, request or other document to be given hereunder to a party
hereto shall be effective when received and shall be given in writing and
delivered in person or sent by overnight courier, registered or
certificated mail, or postage prepaid or by telecopy (receipt confirmed) to
the address of the respective party set forth below or to such other
address as such party may hereafter designate by notice in accordance with
this Article 9.4.
To Nephros:
Xx. Xxxxxx Xxxxx
Nephros, Inc.
0000 Xxxxxxxx
Xxx Xxxx, XX 00000, X.X.X.
Phone: (000) 000-0000
Fax: (000) 000-0000
To Asahi:
Xx. Xxxxx Xxxxxxx
Asahi Kasei Medical Co., Ltd.
0-0, Xxxxx Xxxxxxxxxxxx, Xxxxxxx-xx, Xxxxx, Xxxxx
Phone: 0-0000-0000
Fax: 0-0000-0000
Notices shall be deemed to have been given on the date of receipt if
delivered in person or sent by telecopy, or on the tenth business day after
posting if sent by overnight courier, registered or certified mail, or
postage prepaid.
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9.5 Assignment
This Agreement shall be binding upon and inure to the benefit of the
parties hereto and their respective successors and assignees; provided that
neither of the parties hereto may assign or transfer its rights or
obligations hereunder to an entity that is a direct competitor with the
other party without the prior written consent of the other party hereto,
and that it is understood that each party hereto may assign or transfer its
rights or obligations hereunder to its affiliate (as defined below) and any
entity that is not a direct competitor with the other party without prior
written consent of the other party hereto.
The term "affiliate" shall mean an entity that directly or indirectly,
through one or more intermediaries, controls, is controlled by or is under
common control with, a party hereto on the Effective Date. As used in the
above, " control" means the ability to own directly or indirectly fifty
percent (50%) or more of the issued and outstanding capital stock having
the right to vote for the election of directors.
9.6 Entire Agreement
This Agreement supersedes all prior agreements, understandings,
representations, and statements, if any, regarding the subject matter
contained herein, whether oral or written (with the exception of the
CONFIDENTIALITY AGREEEMNT set forth in second Whereas hereof) and no
amendment of this Agreement shall be valid and binding upon the parties
unless made in writing and signed on behalf of each of such parties by
their respective authorized officers.
9.7 Severability
If any provision or provisions of this Agreement shall be held to be
illegal, invalid or unenforceable, the validity, legality and
enforceability of the remaining provisions shall not in any way be affected
or impaired thereby.
9.8 Waiver
The waiver of any default under this Agreement by either party shall not
constitute a waiver of any rights for any subsequent default.
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9.9 Governing Law
This Agreement shall be construed and interpreted in accordance with the
laws of the State of New York, U.S.A., without regard to conflicts of laws
principles thereof.
9.10 Arbitration
In the event of any dispute arising in connection with this Agreement, the
parties will endeavor to negotiate a mutually satisfactory solution. If
such solution cannot be reached, the dispute shall, at either party's
advance written demand, be finally settled by arbitration in accordance
with the rules of Conciliation and Arbitration of the International Chamber
of Commerce. Nephros and Asahi shall each appoint one arbitrator and these
two arbitrators shall appoint the third. If the two arbitrators cannot
agree on the third arbitrator, he shall then be appointed in accordance
with such Rules. The arbitration shall take place: (a) in New York, U.S.A.
if the arbitration is demanded by Asahi; and (b) in Tokyo, Japan if the
arbitration is demanded by Nephros. The arbitration shall be held in the
English language.
9.11 Counterparts
This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one
and the same instrument.
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IN WITNESS WHEREOF, the parties have executed this Agreement as of the day and
year first above written.
Nephros, Inc.
By: /s/ Xxxxxx X. Xxxxx
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Title: CEO
-----------------------------------
Date: 25 Feb. 05
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Asahi Kasei Medical Co., Ltd.
By: /s/ Xxxxx Xxxxxxx
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Title: President
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Date: March 2nd, 2005
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