Memorandum - Asahi Medical Co. Ltd., OccuLogix Corp. and Apheresis Technologies Inc.
MEMORANDUM
This Memorandum is made on 31st of December 2001 (hereinafter called "ASSIGNED
DAY"), by and among ASAHI MEDICAL CO., LTD., a corporation organized and
existing under the laws of Japan, with its principal place at 9-1, Kanda
Mitoshirocho, Chiyoda-ku, Tokyo, Japan (hereinafter called "ASAHI"), OCCULOGIX
CORPORATION, a corporation organized and existing under the laws of the State of
Florida, the United States of America, with its principal place at 612 Florida
Avenue, Palm Harbor, Florida 34683, the United States of America (hereinafter
called "OCCULOGIX"), and APHERESIS TECHNOLOGIES, INC., a corporation organized
and existing under the laws of the State of Florida, the United States of
America, with its principal place at 612 Florida Avenue, Palm Harbor, Florida
34683, the United States of America (hereinafter called "ATI").
BACKGROUND
OCCULOGIX and ATI, as a wholly owned subsidiary of OCCULOGIX, have jointly and
severally engaged in sales, marketing, and exploring regulatory approvals of
certain plasma therapy products manufactured by ASAHI in the Territory
(hereinafter defined) under the terms and conditions of the following six (6)
agreements (hereinafter collectively called "AGREEMENTS"):
1. 1997 DISTRIBUTORSHIP AGREEMENT made on February 1, 1997 (hereinafter
called "AGREEMENT-I")
2. Plasmaflo AGREEMENT made on June 1, 1997 (hereinafter called
"AGREEMENT-II")
3. MEMORANDUM made on April 1, 1998
4. AMENDMENT to 1997 DISTRIBUTORSHIP AGREEMENT and Plasmaflo AGREEMENT made
on January 1, 1999
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5. 2000 AGREEMENT made on September 1, 2000
6. SECOND AMENDMENT to 1997 DISTRIBUTORSHIP AGREEMENT and Plasmaflo AGREEMENT
made on November 1, 2000
OCCULOGIX splits off ATI as of ASSIGNED DAY and each company will be engaged in
the following business respectively:
A) OCCULOGIX:
i) Exploring to obtain, at its own expenses, the FDA approval of
Product I (defined in AGREEMENT-I) for Treatment Disease (defined in
AGREEMENT-I)
ii) Distributing aforesaid Product I in the Territory
B) ATI:
i) Sales and marketing of Product II (defined in AGREEMENT-I) in the
Territory
ii) Exploring to obtain, at its own expenses, the FDA approval of
Product (defined in AGREEMENT-II) for TPE (defined in AGREEMENT-II)
iii) Distributing the aforesaid Product II and Product in the Territory
ASAHI accepted such split and is desirous that each of them will engage in each
business relating to ASAHI's products.
NOW, THEREFORE, it is agreed among the three parties as follows:
1. The AGREEMENTS shall terminate as of ASSIGNED DAY.
2. ASAHI and OCCULOGIX shall newly enter into a distributorship agreement for
the distribution of Product-I (defined in AGREEMENT-I) for Treatment
Disease (defined in AGREEMENT-I) as of ASSIGNED DAY.
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3. ASAHI and ATI shall newly enter into a distributorship agreement for the
distribution of Product-II (defined in AGREEMENT-I) and of Product
(defined in AGREEMENT-II) for TPE (defined in AGREEMENT-II) as of ASSIGNED
DAY.
IN WITNESS WHEREOF, the three parties hereto have caused this Memorandum to be
executed by their respective duly authorized representatives as of ASSIGNED DAY.
Signed and agreed by
/s/ Akihiro Isobe /s/ John B. Cornish
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Akihiro Isobe John B. Cornish
President President
ASAHI MEDICAL CO., LTD. APHERESIS TECHNOLOGIES, INC.
/s/ Richard C. Davis
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OCCULOGIX CORPORATION
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2000 AGREEMENT
This AGREEMENT is made on the first day of September, 2000 by and among ASAHI
MEDICAL CO., LTD., a corporation organized and existing under the laws of Japan,
with its principal place of business at 9-1, Kanda Mitoshirocho, Chiyoda-ku,
Tokyo, 101-8482 Japan (hereinafter called "ASAHI"), OCCULOGIX CORPORATION, a
corporation organized and existing under the laws of State of Florida with its
principal place of business at 2575 Ulmerton Road, Suite 210, Clearwater,
Florida 34622, the United States of America (hereinafter called "OCCULOGIX"),
and APHERESIS TECHNOLOGIES, INC., a corporation organized and existing under the
laws of State of Florida with its principal place of business at 612 Florida
Avenue, Palm Harbor, Florida 34683 , the United States of America (hereinafter
called "ATI").
BACKGROUND
ASAHI and ATI entered into the following agreements (hereinafter collectively
called "AGREEMENTS"), which are effective as of the day above written.
1. 1997 DISTRIBUTORSHIP AGREEMENT made on February 1, 1997
2. Plasmaflo AGREEMENT made on June 1, 1997
3. MEMORANDUM made on April 1, 1998
4. AMENDMENT to 1997 DISTRIBUTORSHIP AGREEMENT and Plasmaflo AGREEMENT made
on January 1, 1999
5. STANDARD OPERATION PROCEDURE BETWEEN ASAHI MEDICAL CO., LTD. AND APHERESIS
TECHNOLOGIES, INC. FOR THE AM QUALITY REPORTING PROGRAM made on July 31,
1996
Since signing the AGREEMENTS, ATI has engaged in sales, marketing, and exploring
regulatory approvals of certain plasma therapy products manufactured by ASAHI,
in the countries defined in the AGREEMENTS (hereinafter called "TERRITORY").
OCCULOGIX now desires to acquire ATI, and ATI desires to operate as a wholly
owned subsidiary of OCCULOGIX after acquisition. Furthermore, OCCULOGIX and ATI
desire to continue acting as distributors of ASAHI plasma therapy products in
the TERRITORY. The purpose of such acquisition is to ensure more effective
sales, marketing, and regulatory work relating to ASAHI plasma therapy products.
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ASAHI recognizes that said acquisition of ATI by OCCULOGIX does not adversely
affect sales, marketing, and exploring regulatory approvals of ASAHI plasma
therapy products, and is willing for the AGREEMENTS to remain effective.
NOW, THEREFORE, it is agreed among the three parties as follows
1. The AGREEMENTS shall remain in effect after acquisition of ATI by
OCCULOGIX. The party "ATI" referred to in the AGREEMENTS shall be
interpreted as "OCCULOGIX and/or ATI" as soon as acquisition of ATI by
OCCULOGIX is effective.
2. OCCULOGIX and ATI shall jointly and severally assume the rights and
obligations stipulated in the AGREEMENTS.
3. OCCULOGIX and ATI shall also include their affiliate company(ies), which
are the organizations that are more than fifty percent (50%) owned or
controlled by OCCULOGIX and/or ATI (hereinafter called "AFFILIATE(S)").
4. Notwithstanding Paragraph 3 hereof, the marketing, sales and distribution
by AFFILIATE of ASAHI plasma therapy/blood purification products defined
in the AGREEMENTS shall be subject to ASAHI's prior approval in writing.
IN WITNESS WHEREOF, the three parties hereto have caused this AGREEMENT to be
executed by their respective duly authorized representatives as of the day and
year first above written.
Date: September 1, 2000
___________________________________ ____________________________
Richard C. Davis Jr., M.D. John B. Cornish
Chairman and Chief Science Officer President
OCCULOGIX CORPORATION APHERESIS TECHNOLOGIES, INC.
___________________________________
Akihiro Isobe
President
ASAHI MEDICAL CO., LTD.
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DISTRIBUTORSHIP AGREEMENT
This Distributorship Agreement made on _______________ (hereinafter referred to
as "EFFECTIVE DATE"), by and between ASAHI MEDICAL CO., LTD., a corporation
organized and existing under the laws of Japan, with its principal place of
business at 9-1, Kanda Mitoshirocho, Chiyoda-ku, Tokyo, Japan (hereinafter
referred to as "ASAHI"), and OCCULOGIX CORPORATION, a corporation organized and
existing under the laws of the State of Florida, the United States of America,
with its principal place of business at 612 Florida Avenue, Palm Harbor, Florida
34683, the United States of America (hereinafter referred to as "OCCULOGIX"):
WITNESSETH
WHEREAS, ASAHI desires to sell and market the Product (hereinafter defined) and
granting to OCCULOGIX certain distributor rights with respect to the Product in
the Territory (hereinafter defined); and
WHEREAS, OCCULOGIX is desirous of distributing the Product in the Territory.
NOW, THEREFORE, for and in consideration of the mutual covenants and premises
hereinafter set forth, and other good and valuable consideration, the
sufficiency of which is hereby acknowledged, the parties hereto agree as
follows:
ARTICLE 1. DEFINITIONS
As used in this Agreement, the following terms shall have the following meanings
respectively:
A. "Product" shall mean the products set forth in attached Exhibit A hereto.
The first and the second filter set forth in Exhibit A shall always be
used together for the Treatment Disease.
B. "Territory" shall mean U.S., Canada, Mexico, Commonwealth of The Bahamas,
Dominican Republic, Republic of Haiti, Puerto Rico, Jamaica, Antigua and
Barbuda, Commonwealth of Dominica, Barbados, Republic of Trinidad and
Tobago, Grenada, Saint Thomas, Saint Lucia, Saint Christopher and Nevis,
Saint Vincent and the Grenadines, Caicos Islands, and Virgin Islands of
the United States of America.
C. "Treatment Disease" shall mean a disease of an age-related macular
degeneration, which is considered as one of the theological disorders.
D. "FDA" shall mean the Federal Food and Drug Administration in the U.S.
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E. "OCCULOGIX" shall also include its affiliate company(s), which are the
organizations that are more than fifty percent (50%) owned or controlled
by OCCULOGIX (hereinafter referred to as "AFFILIATE(S)"). Notwithstanding
the above, the marketing, sales and distribution by AFFILIATE of ASAHI's
plasma therapy/blood purification products defined in this Agreement shall
be subject to ASAHI's prior approval in writing.
ARTICLE 2. DISTRIBUTORSHIP
2.1 ASAHI hereby appoints OCCULOGIX as its exclusive distributor in the
Territory for the sale of Product solely used for the Treatment Disease,
provided, however, that OCCULOGIX obtains the FDA approval and other
necessary approvals in the Territory according to Article 7 of this
Agreement. OCCULOGIX agrees to act as such exclusive distributor under the
terms and conditions of this Agreement.
2.2 This Agreement does not construe OCCULOGIX as the agent or legal
representative of ASAHI for any purpose whatsoever. OCCULOGIX is not
granted any right or authority to assume or to create any obligation or
responsibility, expressed or implied, on behalf of or in the name of ASAHI
or to bind ASAHI in any manner or thing whatsoever, or to accept any legal
process addressed to or intended for ASAHI.
2.3 OCCULOGIX shall not, directly or indirectly, seek customers for the
Product or establish a branch or distribution depot related to the Product
outside the Territory.
2.4 OCCULOGIX shall not represent, market, nor sell any similar to or
competitive products with Product during the term of this Agreement.
2.5 OCCULOGIX shall be solely responsible for all expenses and costs incurred
in performing its duties hereunder, including, without limitation, all of
its own operating and sales promotion expenses.
2.6 OCCULOGIX shall use its best efforts to promote the sale and use of, and
to secure orders and develop the market for the Product in the Territory.
The business conducted by OCCULOGIX in connection with the marketing of
the Product shall at all times be conducted and maintained so as not to
detract from, interfere with or adversely reflect upon the goodwill and
reputation of ASAHI, its trademarks and/or trade names and the Product.
2.7 OCCULOGIX also shall make its best efforts that public and private medical
insurance reimbursement shall be applied for the Treatment Disease using
the Product in the U.S.
ARTICLE 3. MINIMUM AND TARGET PURCHASE REQUIREMENT
3.1 OCCULOGIX shall purchase Product from ASAHI in not less than the following
quantities:
First year: 9, 000 pieces of each filter i.e. First and Second filter
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Second year: 15,000 pieces of each filter i.e. First and Second filter
Third year: 22,500 pieces of each filter i.e. First and Second filter
The above minimum purchase quantities shall be effective from six (6 )
months after OCCULOGIX obtains the FDA approval of Product.
The minimum purchase quantities for the Fourth year shall be discussed and
determined immediately after the term of the First year by mutual consent,
but shall not be less than that of the previous year. The minimum purchase
quantities for the Five year shall be discussed and determined immediately
after the term of the Second year by mutual consent, but shall not be less
than that of the previous year. This same method shall be used in the
Sixth year and thereafter, for the determination of future minimum
purchase quantities, such that minimum purchase quantities are always
fixed for three years.
3.2 For the purpose of this Article, the Product shall be considered purchased
when the Product has actually been delivered as defined in Paragraph 4.6.
ARTICLE 4. ORDER AND DELIVERY
4.1 For the purpose of sales planning by ASAHI, OCCULOGIX shall submit to
ASAHI, in writing, before the twentieth (20th) day of each calendar
quarter a report of OCCULOGIX's sales and inventory of the Product,
including the level of inventory of the Product by article. OCCULOGIX also
shall submit to ASAHI, upon request from time to time, information in its
possession with respect to competitors' state of marketing and general
market information, relevant economic, political and business conditions
in the Territory, and texts and summaries of governmental statutes, rules
and regulations established or revised from time to time, affecting the
marketing or sale of the Product in the Territory.
4.2 OCCULOGIX shall submit to ASAHI a calendar monthly rolling order forecast
by the end of each calendar month for the six (6) calendar month period
immediately following such calendar month. The rolling order forecasts for
the first two (2) months of each such six (6) month period shall be deemed
a firm order for the Product, and each monthly forecast shall be
consistent with previous forecasts with respect to such firm orders.
4.3 ASAHI shall have the right to reject any order but agree not to
unreasonably reject any order placed by OCCULOGIX to satisfy its minimum
purchase obligations of Product (as set forth above in Paragraph 3.1).
OCCULOGIX's order shall be deemed accepted when it is acknowledged and
accepted by ASAHI in writing. OCCULOGIX may not cancel any order after it
is accepted by ASAHI without the written consent of ASAHI.
4.4 ASAHI shall make its efforts to deliver the Product in accordance with the
delivery schedules set forth in the accepted orders. However, if anything
beyond the control of ASAHI prevents ASAHI from completely filling orders
accepted by ASAHI in accordance with the Paragraph 4.3, a delayed and/or
partial shipment shall be accepted by
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OCCULOGIX. ASAHI shall notify OCCULOGIX promptly if it anticipates any
potential delay.
4.5 If OCCULOGIX submits to ASAHI a reasonable order forecast of Product
stipulated in Paragraph 4.2 above and when it becomes clear that ASAHI may
significantly be unable to meet such forecast or orders of Product for a
period of more than six (6) months, both parties shall consult and discuss
to reach a mutually acceptable resolution of the matter. If both parties
cannot reach an acceptable resolution, notwithstanding Paragraph 2.4 of
this Agreement, OCCULOGIX may obtain competitive product(s) with Product
from the third party with prior written consent of ASAHI; provided,
however, that such OCCULOGIX purchase is necessary to meet customers'
demand in the Territory and shall be ceased immediately when ASAHI is able
to resolve the situation described in the foregoing sentence.
4.6 The delivery of the Product shall be at the loading port in Japan on the
basis of "FOB" as defined in INCOTERMS/1990, and parties' respective
obligations shall be determined in accordance with INCOTERMS/2000.
ARTICLE 5. PRICES AND TERMS OF PAYMENT
5.1 The prices of the Product shall be as set forth in the price list to be
issued to OCCULOGIX by ASAHI from time to time but not later than sixty
(60) days before the effective date of such price list, provided that the
price of any product of the Product in a given calendar year shall not
exceed one hundred and twenty percent (120% ) of the price effective at
the end of the preceding calendar year, unless any of the following
circumstances arise during a given calendar year;
(a) significant change of. currency exchange rate, or
(b) significant increase of production cost of the Product, or
(c) any events beyond ASAHI's control.
With respect to Product, quantity discount shall be reasonably determined
when the minimum purchase quantity is determined in accordance with
Paragraph 3.1.
5.2 As soon as OCCULOGIX receives ASAHI's acceptance of the order, OCCULOGIX
shall open an irrevocable letter of credit (hereinafter referred to as
"L/C") at thirty (30) days after Bill of Lading (B/L) date in favor of
ASAHI by full cable confirmed by a Japanese, European or American bank
which ASAHI accepts in advance or shall make the advanced payment by money
transfer in favor of ASAHI to ASAHI's designated account. Any bank charges
related to L/C opening, L/C amendment and advanced payment shall be borne
by OCCULOGIX.
5.3 Payments under the preceding paragraphs shall be made in the currency of
U.S. dollars.
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ARTICLE 6. RISK OF LOSS AND TITLE
The title to and risk of loss of the Product shall pass from ASAHI to OCCULOGIX
at the time when the purchased Product have been handed over to the carrier or
to another person acting on his behalf as defined in INCOTERMS/1990. All risks
of loss and expenses in connection with such Product thereafter shall rest upon
OCCULOGIX, including, without limitation all risks and expenses incurred in the
storage, cartage and transportation of the Product as well as all insurance,
fee, charges, taxes (whether sales use, value added or other), customs duties,
and governmental charges or levies and all other charges and expenses of any
nature whatsoever, thereafter incurred with respect to the Product, whether the
same are levied upon ASAHI or OCCULOGIX. ASAHI shall not be deemed in any way
responsible for obtaining such freight and/or insurance, and shall not in any
way be liable for the transportation, cartage, insurance or other aspects of the
storage or shipment of the Product, after passage of title thereto to OCCULOGIX
as set forth above.
ARTICLE 7. REGULATORY APPROVAL
7.1 OCCULOGIX shall be responsible, at its own costs and expenses, for
obtaining and maintaining the FDA and all other applicable approvals and
validations for the marketing, sales and use of Product for the Treatment
Disease in each country of the Territory under the name of ASAHI by the
end of July, 2003. If the above approvals cannot be obtained by such day
and year, OCCULOGIX shall consult with ASAHI and attempt to reach a mutual
acceptable resolution. Despite consultation, if both parties cannot find a
mutual acceptable resolution, ASAHI may delete Product from this Agreement
upon six (6) months prior written notice to OCCULOGIX.
7.2 OCCULOGIX shall submit the protocol of the clinical trial for obtaining
the FDA approval to ASAHI four (4) months before the start of the clinical
trial and inform ASAHI of the necessary quantity and timing of Product in
order to carry out the clinical trial. ASAHI has shipped to OCCULOGIX
one-hundred and seventeen (117) dozens of Product, free of charge for the
clinical trial to obtain the FDA approval for the Treatment Disease. In
excess of one-hundred and seventeen (117) dozens of Product, if OCCULOGIX
needs more Product for the clinical trial to obtain the FDA approval,
ASAHI may, at its discretion, supply Product at the price stipulated in
ASAHI's price list.
7.3 OCCULOGIX shall inform ASAHI of the documentation which is necessary for
the FDA approval related to Product. Upon OCCULOGIX's request, ASAHI shall
make its best efforts to provide technical data of Product within ASAHI's
capacity.
7.4 OCCULOGIX shall not be entitled to any compensation from ASAHI even when
OCCULOGIX may not obtain the FDA approval of Product.
7.5 OCCULOGIX shall endeavor to obtain, at its own expenses, the FDA approval
and other necessary approvals in the Territory of the accessories of the
Product, such as blood pump or tubing set, which may be required for the
Treatment Disease.
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7.6 In addition to this Agreement. ASAHI and OCCULOGIX shall enter into an
agreement which indicates the standard operating procedure for ASAHI's
quality reporting program (hereinafter referred to as "S.O.P.").
7.7 Without limiting any other provision in this Agreement, OCCULOGIX shall
fully comply with the FDA's Medical Device Reporting (hereinafter referred
to as "M.D.R.") Regulation and with the S.O.P.
ARTICLE 8. SUPPLY AND FIRST REFUSAL RIGHT
8.1 Subject to the provisions in Paragraph 4.3, ASAHI shall continue to supply
Product to OCCULOGIX during the term of this Agreement after OCCULOGIX
obtains the FDA approval of Product; provided, however, in the following
events, that ASAHI may, with twelve (12 ) months prior written notice to
OCCULOGIX and without any compensation to OCCULOGIX, discontinue the
manufacture and supply of any of Product: if
(a) due to the decrease in the demand of any of Product, the exchange
rate situation, or price of raw materials, ASAHI cannot economically
manufacture or supply Product, or
(b) due to the special circumstances, such as patent infringement
liability or product liability issues of Product or the treatment
using Product, ASAHI cannot manufacture or supply Product, or
(c) ASAHI develops improved products which may be used in place of any
product of Product and ASAHI cannot economically manufacture or
supply Product.
In the event that any of the above circumstances arise, OCCULOGIX shall be
given an opportunity to consult with ASAHI to seek a mutually acceptable
resolution, after said twelve (12) months prior written notice is given by
ASAHI to OCCULOGIX. Despite consultation, if both parties cannot find a
mutually acceptable resolution, ASAHI may discontinue the manufacture and
supply of Product without any compensation or other obligation to
OCCULOGIX.
8.2 In the event of the circumstance of Paragraph 8.1(c) above, OCCULOGIX may
have the first refusal right to obtain the distribution rights of such
improved product(s) of Product solely used for the Treatment Disease in
the Territory under the terms and conditions by mutual consent; provided,
however, that OCCULOGIX shall, at its own costs and expenses, obtain the
FDA and other applicable approvals of such products for the Treatment
Disease in the Territory within a reasonable period.
8.3 OCCULOGIX may also have the first refusal right to obtain the exclusive
distribution rights in the Territory of:
(a) Product which shall be solely used for the treatment of Retinopathy
which is one of eye diseases and/or other specific diseases in the
scope of the hemo-rheological disorders than the Treatment Disease,
and
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(b) the first filter only, set forth in Exhibit A, which shall be solely
used for the Treatment Disease, Retinopathy and/or other specific
diseases in the scope of hemo-rheological disorders, under the terms
and conditions mutually agreed on between both parties; provided,
however, that
(i) OCCULOGIX shall, at its own costs and expenses, obtain the FDA approval of
such product for such Treatment Disease, Retinopathy and/or hemo-rheological
disorders within a reasonable period, and
(ii) both parties agree that the aforementioned specific diseases are considered
in the scope of the hemo-rheological disorders.
8.4 Notwithstanding anything herein contained to the contrary, it is hereby
expressly understood by both parties hereto that ASAHI may, directly or
indirectly, market or sell ASAHI's plasma filter(s) other than Product for
the Treatment Disease or any other diseases in the Territory.
ARTICLE 9. WARRANTY
9.1 If any Product is in a damaged condition upon its delivery to OCCULOGIX,
or the amount delivered is less than that provided for in the order
accepted by ASAHI, OCCULOGIX shall advise ASAHI in writing of any such
circumstance within six (6) months of delivery of such Product and shall
fully describe the nature of the shortage or damage. ASAHI shall replace
such damaged Product and/or remedy such shortages, without additional
charge, provided that, ASAHI is given the notice referred to above and the
opportunity promptly to inspect the claimed damaged or incompletely
delivered Product, and provided further that ASAHI is reasonably satisfied
that such damage and/or shortage was not caused by mishandling or misuse
by the parties other than ASAHI after title passed to OCCULOGIX. In the
event that OCCULOGIX fails to notify ASAHI or allow such inspection as
described above, OCCULOGIX shall be deemed to have waived all damage and
shortage claims against ASAHI.
9.2 ASAHI warrants exclusively to OCCULOGIX and to no other person, firm or
corporation that each Product is manufactured and inspected in accordance
with ASAHI's quality system. In the event that a defect covered by this
warranty is found and notice is given to ASAHI with full particulars
thereof within six (6) months after delivery of the Product, as required
by Paragraph 9.1, ASAHI undertakes to replace the defective Product
without additional charge; provided, however, that any and all component
parts of or other articles utilized in connection with the Product
manufactured by any manufacturer other than ASAHI shall be subject only to
the applicable warranty provided by such other manufacturer and ASAHI will
have no responsibility therefor, and provided further that all warranties
described above in this Paragraph 9.2 shall be ineffective, and ASAHI
shall have no responsibility whatsoever, in the event any Product has been
subjected to misuse, mishandling, misapplication, neglect, contamination,
accident, improper repair, damage by circumstances beyond ASAHI's
reasonable control or unauthorized modification by OCCULOGIX or its
mediate or immediate customers,
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including, without limitation, any damage, contamination, defects or
malfunctions resulting from (i) the opening of the packaging of the
Product to combine the blood line to be procured by OCCULOGIX and to be
used for the Product, (ii) the repackaging of the Product with the blood
line for delivery to customers, or (iii) the failure to adhere to
instructions for use and other documentation included by ASAHI with its
shipments of the Product. The responsibility of ASAHI under all warranties
is limited solely to the repair or replacement of the Product, as the case
may be, pursuant to the foregoing warranties. All warranty claims are
subject to verification by ASAHI.
9.3 THE WARRANTIES SET FORTH ABOVE ARE EXCLUSIVE AND IN LIEU OF, AND ASAHI
EXPRESSLY DISCLAIMS, ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING,
WITHOUT LIMITATION, ANY WARRANTY OF MERCHANTABILITY OR FITNESS FOR A
PARTICULAR USE OR PURPOSE AND THOSE ARISING BY STATUTE OR OTHERWISE IN LAW
OR FROM A COURSE OF DEALING OR USE OF TRADE. ASAHI SHALL NOT HAVE ANY
LIABILITY TO OCCULOGIX, CUSTOMERS, END-USERS OR ANY OTHER PARTY FOR ANY
AMOUNTS IN EXCESS OF THE ORDER PRICE OF THE PRODUCT NOR FOR SPECIAL,
INCIDENTAL OR CONSEQUENTIAL DAMAGES, INCLUDING, WITHOUT LIMITATION, LOST
PROFITS OR PROSPECTIVE PROFITS OR ANY OTHER COMMERCIAL OR ECONOMIC LOSS OF
ANY KIND OR NATURE OF OCCULOGIX OR ANY THIRD PERSON, EVEN IF ASAHI HAS
BEEN ADVISED OF THE POSSIBILITY OF THE SAME, ARISING OUT OF OR IN
-CONNECTION WITH THE USE OR PERFORMANCE OF THE PRODUCT.
9.4 OCCULOGIX shall not represent, in relation to the Product purchased
hereunder, to its customers any warranties of any nature whatsoever other
than those given by ASAHI or required by applicable law.
ARTICLE 10. TRADEMARK AND OTHER RIGHTS
10.1 OCCULOGIX shall use the trademark(s) designated by ASAHI (hereinafter
referred to as "Trademark"), including, without limitation, "Plasmaflo"
and "Rheofilter", as instructed by ASAHI in distributing the Product
purchased hereunder and shall not use any other trademarks in connection
with such distribution without prior written consent of ASAHI. OCCULOGIX
acknowledges that, as between ASAHI and OCCULOGIX, ASAHI is the owner of
all right, title and interest in and to the Trademark in the Territory in
any form or embodiment thereof and is the owner of the goodwill attached
or which shall become attached to the Trademark in connection with the
business and goods in relation to which the same has been, is or shall be
used. Sales by OCCULOGIX shall be deemed to have been made by ASAHI for
purposes of trademark registration and all uses of the Trademark by
OCCULOGIX shall inure to the benefit of ASAHI. OCCULOGIX shall not, at any
time, do or suffer to be done any act or thing which may in any way
adversely affect any rights of ASAHI in and to the Trademark or any
registrations thereof or which, directly or indirectly, may reduce the
value of the Trademark or detract from its reputation. At ASAHI's request,
OCCULOGIX shall execute any documents, including registered user
agreements, reasonably required by ASAHI to confirm ASAHI's
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ownership of all rights in and to the Trademark in the Territory and to
confirm the respective rights of ASAHI and OCCULOGIX under this Agreement.
OCCULOGIX shall not alter, obliterate, deface or remove any mark, marking,
serial number or other symbol carried on the Product or on the packaging
in which the Product are enclosed without the consent of ASAHI. In the
event that ASAHI desires to change any such mark, marking, serial number
or other symbol, OCCULOGIX will cooperate with ASAHI in such manner as may
be agreed upon by the parties. OCCULOGIX never shall challenge ASAHI's
ownership of or the validity of the Trademark or any application for
registration thereof, or any trademark registrations thereof, or any
rights of ASAHI therein.
10.2 During the term of this Agreement and thereafter, OCCULOGIX shall not
apply for or acquire the registration of the Trademark, nor shall
OCCULOGIX contest ASAHI's right in or disturb ASAHI's use of the trademark
or goodwill. Should OCCULOGIX have the Trademark registered in its name or
name of any other person, ASAHI shall have the right to have the
registration canceled or transferred to ASAHI.
10.3 In the event that OCCULOGIX learns of any infringement or imitation of the
Trademark or of any use by any person of any trademark similar to the
Trademark, it promptly shall notify ASAHI thereof. ASAHI thereupon shall
take such action as it deems advisable for the protection of its rights in
and to the Trademark and, if requested to do so by ASAHI, OCCULOGIX shall
cooperate with ASAHI in all respects at ASAHI's sole expense. In no event,
however, shall ASAHI be required to take any action if it deems it
inadvisable to do so and OCCULOGIX shall have no right to take any action
with respect to the Trademark without ASAHI's prior written approval.
10.4 Upon the termination of this Agreement for any reason whatsoever,
OCCULOGIX shall, except as ASAHI may specifically authorize in writing,
immediately cease and desist from carrying on any and all use of any
trademarks, trade names, words or symbols of any nature indicating,
explicitly or implicitly, that it is an authorized ASAHI distributor or
dealer of ASAHI's products or other ASAHI goods and services.
10.5 Any patent, design, copyright and other intellectual property rights
embodied in the Product shall be the sole property of ASAHI or the third
party designated by ASAHI, and OCCULOGIX shall not, either directly or
indirectly, contest nor assist others in contesting the validity of such
intellectual property rights. ASAHI shall be entitled to terminate this
Agreement forthwith on notice to OCCULOGIX if OCCULOGIX should violate
said obligation. OCCULOGIX shall not acquire any right in the Product by
execution of this Agreement or performance hereunder or otherwise and
shall not use any of them after termination of this Agreement resulting
from expiration of its term or any other cause whatsoever.
10.6 Nothing in this Agreement shall be construed as a warranty or
representation that the Product or the use thereof will be free from
infringement of any patent or other intellectual property rights of any
third party. ASAHI shall not be under any obligation to defend, or to
participate in the defense of, OCCULOGIX against any claim or suit
alleging such infringement; provided, however, that ASAHI shall, at
OCCULOGIX's costs, cooperate and assist OCCULOGIX in the defense of any
such claim or suit.
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<PAGE>
10.7 In the event that OCCULOGIX obtains any intellectual property right
relating to the Treatment Disease using Product, ASAHI shall have the
first refusal right to obtain a non-exclusive right and license from
OCCULOGIX to use such intellectual property right for manufacture, sell
and use of Product (i) outside the Territory during the term of this
Agreement and, (ii)within the Territory after expiration or termination of
this Agreement pursuant to Paragraph 18.1 or 19.1, or after the conversion
into non-exclusive right pursuant to Paragraph 19.3.
ARTICLE 11. PROMOTION AND ADVERTISEMENT
OCCULOGIX shall exert its best efforts in marketing, promoting and advertising
the Product at its own costs.
ARTICLE 12. INVENTORY
OCCULOGIX shall maintain sufficient stock of the Product for the purpose of
distribution at its own cost, and shall deliver the Product to its customers by
a "first-in, first-out" method.
ARTICLE 13. INDEMNIFICATION AND PRODUCT LIABILITY INSURANCE
13.1 OCCULOGIX shall defend and indemnify ASAHI against, and hold ASAHI
harmless from, any loss, cost, liability or expense (including court costs
and reasonable fees of attorneys and other professionals) arising or
alleged to arise out of the conduct of OCCULOGIX in connection with
OCCULOGIX's use, distribution, promotion, technical and in-service
training, sale of the Product; provided, however, that (i) OCCULOGIX shall
have sole control of such defense, and (ii) ASAHI shall provide notice
promptly to OCCULOGIX of any actual or threatened claim of which ASAHI
becomes aware.
13.2 ASAHI shall defend and indemnify OCCULOGIX against, and hold OCCULOGIX
harmless from, any loss, cost, liability or expense (including court costs
and reasonable fees of attorneys and other professionals) arising or
alleged to arise out of the conduct of ASAHI in connection with the
manufacture of the Product; provided, however, that (i) ASAHI shall have
sole control of such defense, and (ii) OCCULOGIX shall provide notice
promptly to ASAHI of any actual or threatened claim of which OCCULOGIX
becomes aware.
13.3 Each party shall be responsible for maintaining reasonable product
liability insurance coverage with respect to the Product in the Territory
at all times during the term of this Agreement and thereafter until the
time when both parties agree upon. Such insurance policy shall be written
for the benefit of both OCCULOGIX and ASAHI. OCCULOGIX shall deliver a
certificate of such insurance to ASAHI promptly upon issuance of said
insurance policy.
13.4 OCCULOGIX shall maintain product liability insurance for the clinical
trial for the FDA approval for Product during the clinical trial and until
the FDA approval. OCCULOGIX
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<PAGE>
shall deliver a certificate of such insurance to ASAHI promptly upon
issuance of said insurance policy.
ARTICLE 14. REPORTS AND INVESTIGATION
14.1 OCCULOGIX shall submit, in writing, to ASAHI the situation and the result
of the clinical trial stipulated in Paragraph 7.2 quarterly within thirty
(30) days after the end of previous quarter. It is expressly understood
that OCCULOGIX shall fully comply with the FDA's M.D.R. Regulation and
with the S.O.P. even during the clinical trial for the FDA approval.
14.2 In addition to the reports to be provided by OCCULOGIX to ASAHI pursuant
to Paragraph 4.1 of this Agreement, OCCULOGIX shall provide ASAHI, on
annual basis, the annual finance statements of OCCULOGIX. As used herein,
the phrase "annual financial statements" shall refer to the income
statement, balance sheet and supporting schedules prepared by the
Certified Public Accountant for OCCULOGIX for each fiscal year and of
OCCULOGIX. Such financial statement shall be prepared in conformity with
generally accepted accounting principles of the U.S. OCCULOGIX shall
forward to ASAHI copies of the annual financial statements within twenty
(20) days of receipt of the finalized annual financial statements from the
Certified Public Accountant utilized by OCCULOGIX.
ARTICLE 15. CONFIDENTIALITY
During the term of this Agreement including any renewal under Article 18 and for
a period of five (5) years thereafter, or ten (10) years after the effective
date of this Agreement, whichever is longer, neither party hereto shall disclose
or otherwise divulge to any third party any confidential information which may
be acquired from the other in connection with the Product, this Agreement, or
its performance, except for any information which:
(a) is known to the public or to the receiving party prior to
disclosure;
(b) is disclosed to the receiving party by a third party under no
obligation of secrecy to the other party after disclosure; or
(c) becomes known to the public through no fault of the receiving party
after disclosure.
ARTICLE 16. ARTICLE 16. FORCE MAJEURE
16.1 Neither party hereto shall be liable to the other in any manner for
failure or delay in fulfillment of all or part of this Agreement, or any
individual contract, which is directly or indirectly owing to any causes
or circumstances beyond that party's control, including, but not limited
to, acts of God, governmental orders or restriction, war, war-like
conditions hostilities, sanctions, mobilization, blockade, embargo,
detention, revolution,
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<PAGE>
riot, looting, strike, lockout, plague or other epidemics, fire,
earthquake, explosion, flood, and shortage of raw materials.
16.2 Notwithstanding the foregoing, no occurrence of an event of Force Majeure
shall relieve OCCULOGIX of its obligation to make any payment hereunder.
ARTICLE 17. ASSIGNMENT
OCCULOGIX shall hot assign, transfer or otherwise dispose of this Agreement,
voluntarily or by operation of law, in whole or in part, to any individual, firm
or corporation without the prior written consent of ASAHI.
ARTICLE 18. TERM
18.1 This Agreement shall be effective from EFFECTIVE DATE until January 31,
2009, unless terminated prior to such expiration date by either party, as
provided herein, and shall automatically be renewed for additional and
successive one (1) year term unless ASAHI or OCCULOGIX gives the other
written notice of its intention to terminate this Agreement at least six
(6) months prior to the expiration date of the term then in effect.
18.2 Notwithstanding the foregoing paragraph, the following paragraphs shall
survive any expiration or termination of this Agreement: Article 9, 10, 13
and 15, Paragraph 19.2, and Article 23.
ARTICLE 19. TERMINATION
19.1 ASAHI may forthwith terminate this Agreement and/or any individual
contract of the Product hereunder without any compensation to OCCULOGIX by
giving a written notice of termination to OCCULOGIX:
A. if OCCULOGIX becomes insolvent or a petition in bankruptcy or for
corporate reorganization or for any similar relief is filed by or against
OCCULOGIX or a receiver is appointed with respect to any of the assets of
OCCULOGIX, or liquidation proceeding is commenced by or against OCCULOGIX;
or
B. if the whole or an important part of the business of OCCULOGIX is
transferred to a third party by agreement, order of court or otherwise,
and such transfer adversely affects the sale of the Product in the
Territory pursuant to this Agreement; or
C. if OCCULOGIX defaults in payment for any Product or any debt owing to
ASAHI or otherwise defaults in relation to any of the provisions of this
Agreement and/or any individual contracts for the Product hereunder except
for those in Paragraphs 2.3 and 2.4 and does not make the payment or
remedy the default within thirty (30) days after a prior written notice is
given requesting the payment or remedy of the default; or
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<PAGE>
D. if any essential changes in the management personnel or ownership of the
shares of OCCULOGIX would adversely affect the sale of the Product in the
Territory pursuant to this Agreement; or
E. if OCCULOGIX violates the prohibition provided for in Paragraphs 2.3 and
2.4 hereof.
19.2 Termination of this Agreement and/or any individual contracts for the
Product hereunder pursuant to the preceding Paragraph shall be without
prejudice and shall be additional to any right of ASAHI under this
Agreement, such individual contracts for the Product, law, statute or
otherwise. Upon termination of this Agreement and/or such individual
contracts for the Product, all payments to be made under this Agreement
and/or such individual contracts in connection with the sale of the
Product hereunder shall become due.
19.3 If OCCULOGIX fails to fulfill the provisions stipulated in the Paragraph
3.1 for the Product, ASAHI may, at its option, modify the exclusive right
granted to OCCULOGIX hereunder to a non-exclusive right.
ARTICLE 20. GOVERNING LAW
This Agreement shall be governed by the laws of Japan.
ARTICLE 21. NON-WAIVER
The waiver, express or implied, by either of the parties hereto of any right
hereunder or of any failure to perform or breach hereof by the other party
hereto shall not constitute or be deemed as a waiver of any other right
hereunder or of any other failure to perform or breach hereof by the other
party, whether of a similar or dissimilar nature.
ARTICLE 22. ENTIRETY
This Agreement and its Exhibit contain the entire agreement of the parties with
respect to the subject matter herein contained and supersedes any prior
Agreements or understandings between the parties except the S.O.P.
ARTICLE 23. ARBITRATION
All disputes, controversies or differences which may arise between the parties,
out of or in relation to or in connection with this Agreement, or for the breach
thereof, shall be settled by mutual consultation between the parties hereto in
good faith as promptly as possible, but failing an amicable settlement, shall be
finally settled by arbitration to be held in Tokyo, Japan under the Rules of
Conciliation and Arbitration of the International Chamber of Commerce, by which
each party hereto agrees to be bound.
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<PAGE>
ARTICLE 24. NOTICE
24.1 Unless otherwise provided in this Agreement, all notices to be given
hereunder shall be in writing and sent by registered airmail to the
respective addresses of the parties stated above or to such other
addresses as may indicated in writing by the parties hereto by notice
pursuant to this Paragraph. If either party has changed its address, a
written notice thereof shall be given to the other party pursuant to this
Paragraph.
24.2 All notices shall be deemed to have been given on the day when such notice
is mailed by registered airmail.
IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed
by their respective duly authorized representatives as of EFFECTIVE DATE:
_______________________
Akihiro Isobe
______________________ President
OCCULOGIX CORPORATION ASAHI MEDICAL CO., LTD.
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Exhibit A
Product
First filter: Plasmaflo OP-05W(L)
Second filter: Rheofilter AR-2000
Product means the set of the above first filter and second
filter which is used together for the Treatment Disease.
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<PAGE>
2003 MEMORANDUM
This Memorandum is made and effective as of October 30, 2003, by and between
ASAHI MEDICAL CO., LTD., a corporation organized and existing under the laws of
Japan, with its principal place of business at 9-1, Kanda Mitoshirocho,
Chiyoda-ku, Tokyo, Japan (hereinafter referred to as "ASAHI"), and VASCULAR
SCIENCES CORPORATION, a corporation organized and existing under the laws of the
State of Delaware, the United States of America, with its principal place of
business at 612 Florida Avenue, Palm Harbor, Florida 34683, the United States of
America (hereinafter referred to as "VSC"), and which is known as its former
name of Occulogix Corporation (hereinafter referred to as "OCCULOGIX"), to
mutually confirm the followings with respect to the five (5) agreements as
below:
1. Distributorship Agreement made by and between ASAHI and OCCULOGIX on
December 31, 2001 (hereinafter referred to as "AGREEMENT")
2. Secured Fixed Rate Note made by and between ASAHI and OCCULOGIX on
February 28, 2001 (hereinafter referred to as "NOTE-1")
3. Amendment No. 1 dated as of November 10, 2001, to NOTE-1 made by and
between ASAHI and OCCULOGIX (hereinafter referred to as "NOTE-2")
4. Consent to Assignment of Contract made by and between ASAHI and
OCCULOGIX on July 25, 2002
5. Amendment No. 2 dated as of November 30, 2002, to NOTE-1 and NOTE-2
made by and between ASAHI and VSC (hereinafter referred to as "NOTE-3")
BACKGROUND
For acceleration and completion of the clinical trials for Treatment Disease
(hereinafter referred to as "CLINICAL TRIAL"), VSC requested ASAHI to be a
stockholder of VSC and to send VSC additional free samples of Product as defined
in the AGREEMENT.
<PAGE>
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VSC also requested ASAHI, due to the delay of CLINICAL TRIAL, to extend the time
limit of VSC's obtaining the FDA approval of Product for Treatment Disease
(hereinafter referred to as "APPROVAL").
Both parties desire to clarify, for obtaining and maintaining APPROVAL, the
procedures of the FDA application of Product for Treatment Disease (hereinafter
referred to as "APPLICATION") and the term "under the name of ASAHI" provided in
the Article 7.1 of AGREEMENT.
NOW, THEREFORE, both parties shall confirm and agree to the followings:
1. Stock Purchase
ASAHI shall convert, from the outstanding principal of the Loan defined
in NOTE-1, five hundred thousand US dollars (US$ 500,000) into five
hundred and seven thousand six hundred and four (507,604) shares of
Common Stock of VSC under the "Stock Purchase Agreement" to be agreed
between ASAHI and VSC within two (2) months after the executed date of
this Memorandum; provided, however, that:
(a) after the date of the said conversion (hereinafter referred to
as "CONVERSION DATE"), the outstanding balance of five hundred
thousand US dollars (US$ 500,000) shall remain as Loan, and
the rights and obligations of each party stipulated in NOTE-1,
NOTE-2 and NOTE-3 shall remain unchanged, and
(b) interest on the principal amount of one million US dollars
(US$ 1,000,000) provided in NOTE-3 shall be accrued from
December 1, 2002 until CONVERSION DATE, and payable within one
(1) week after CONVERSION DATE.
2. Additional Filter Sample Supply
Notwithstanding the Article 7.2 of AGREEMENT, ASAHI shall additionally
ship to VSC up to one-hundred and fifteen (115) dozens of Product free
of charge; provided, however, that:
(a) the expenses of shipment of the said free samples shall be
borne by VSC, and
<PAGE>
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(b) in excess of the said one-hundred and fifteen (115) dozens of
Product, if VSC need more Product, ASAHI may, at its
discretion, supply Product at the price stipulated in ASAHI's
latest price list, and
(c) VSC shall send ASAHI the draft of APPLICATION for ASAHI's
review, soon after the completion of CLINICAL TRIAL and before
submitting APPLICATION to the FDA.
3. Extension of APPROVAL Time Limit
The term "the end of July 2004" referred to in the Article 7.1 of
AGREEMENT shall be replaced with "the end of December 2006". The other
part of the Article 7.1 shall remain unchanged.
4. Procedure of APPLICATION and Ownership
For performance of the Article 7.1 of AGREEMENT, both parties shall
make the following procedures:
(a) VSC shall submit APPLICATION to the FDA as its applicant.
(b) Upon VSC's receipt of APPROVAL from the FDA, VSC shall
transfer to ASAHI the whole ownership of APPROVAL (hereinafter
referred to as "TRANSFER") at its cost and expenses.
(c) Any clinical data contained in APPLICATION (hereinafter
referred to as "DATA") shall continue to belong to VSC after
TRANSFER. ASAHI will have the right to use the DATA in any
territory that VSC is granted distributorship by ASAHI.
<PAGE>
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IN WITNESS WHEREOF, the both parties hereto have caused this Memorandum to be
executed by their authorized representatives written as below.
"Elias Vamvakas" "Jiro Enoki"
----------------------------- -------------------------------
Elias Vamvakas Jiro Enoki
Chairman Managing Director
VASCULAR SCIENCES CORPORATION ASAHI MEDICAL CO., LTD.
Date: October 30, 2003 Date: October 30, 2003
<PAGE>
2004 MEMORANDUM
This Memorandum is made and effective as of "July 28", 2004, by and between
ASAHI MEDICAL CO., LTD., a corporation organized and existing under the laws of
Japan, with its principal place of business at 9-1, Kanda Mitoshirocho,
Chiyoda-ku, Tokyo, Japan (hereinafter referred to as "ASAHI"), and VASCULAR
SCIENCES CORPORATION, a corporation organized and existing under the laws of the
State of Delaware, the United States of America, with its principal place of
business at 612 Florida Avenue, Palm Harbor, Florida 34683, the United States of
America (hereinafter referred to as "VSC"), and which is known as its former
name of Occulogix Corporation and will, subsequent to executing this 2004
Memorandum, change its name to OccuLogix, Inc., to mutually confirm the
following with respect to the two (2) agreements below:
1. Distributorship Agreement made by and between ASAHI and OCCULOGIX on
December 31, 2001 (hereinafter referred to as "AGREEMENT")
2. 2003 Memorandum dated as of October 30, 2003 made by and between ASAHI and
VSC (hereinafter referred to as "2003 MEMORANDUM")
BACKGROUND
ASAHI has indicated its intention to cease production of its cellulose acetate
Rheofilter AR-2000 in 2008 and indicated that it will replace this product with
a new, improved, polysulfone Rheofilter.
VSC has requested that it be permitted to disclose the AGREEMENT and all
amendments thereto from time to time as required under securities laws in the
United States and Canada in connection with, and following VSC's proposed
initial public offering of its common stock.
VSC has also requested that ASAHI consent to its proposed reorganization that it
will undertake in connection with proposed initial public offering of its common
stock.
NOW, THEREFORE, both parties shall confirm and agree to the followings:
1. Right of First Refusal Over Proposed Polysulphone Filter
Pursuant to Article 8.2 of AGREEMENT, VSC hereby exercises its right of
first refusal to obtain the exclusive distribution rights to the new
polysulfone Rheofilter (which will replace the current cellulose acetate
Rheofilter AR-2000) solely used for the Treatment Disease in the Territory,
on terms and conditions to be mutually agreed, but in any event
substantially equivalent to the terms for the current filter. ASAHI hereby
acknowledges and accepts such exercise by VSC.
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<PAGE>
2. Waiver by Confidentiality Obligations
Notwithstanding Article 15 of AGREEMENT, VSC may disclose AGREEMENT and any
amendments made thereto before or after this date, including 2003
MEMORANDUM and this MEMORANDUM, as required in order to comply with
securities laws in the United States and Canada.
3. Consent to VSC Reorganization
ASAHI hereby consents to VSC's corporate reorganization whereby VSC will
purchase TLC Vision Corporation's interest in OccuLogix, L.P. in exchange
for additional shares of VSC and a subsidiary of VSC, and VSC's creation of
new subsidiaries in Canada and the United States to undertake the
activities currently being undertaken by OccuLogix, L.P. For greater
clarity, nothing in this section will expand the Territory set out in
AGREEMENT.
IN WITNESS WHEREOF, the both parties hereto have caused this Memorandum to be
executed by their authorized representatives written as below.
"Elias Vamvakas" "K. Nakamae"
-------------------------------- ---------------------------------
Elias Vamvakas Kenji Nakamae
Chairman President
VASCULAR SCIENCES CORPORATION ASAHI MEDICAL CO., LTD.
Date: "July 28, 2004" Date: "27 July 2004"
2