Contract
2005
MEMORANDUM for Territory Expansion
This
2005
Memorandum for Territory Expansion is made and effective on October 17, 2005
(hereinafter called “EFFECTIVE DATE”), by and between ASAHI KASEI MEDICAL CO.,
LTD., a corporation organized and existing under the laws of Japan, with
its
principal place at 0-0, Xxxxx Xxxxxxxxxxxx, Xxxxxxx-xx, Xxxxx, Xxxxx
(hereinafter called “ASAHI”), and OCCULOGIX, INC., a corporation organized and
existing under the laws of the State of Delaware, the United States of America,
with its principal place at 000 Xxxxxxx Xxxxxx, Xxxx Xxxxxx, Xxxxxxx 00000,
xxx
Xxxxxx Xxxxxx xx Xxxxxxx (hereinafter called “OCCULOGIX”), with respect to the
DISTRIBUTORSHIP AGREEMENT made on December 31, 2001 (hereinafter called
“AGREEMENT”), CONSENT TO ASSIGNMENT CONTRACT made on July 25, 2002, 2003
MEMORANDUM made on October 30, 2003, and 2004 MEMORANDUM made on July 28,
2004.
WITNESSETH
WHEREAS,
OCCULOGIX desires to add some countries to its current Territory defined
in
AGREEMENT and to sell more Product defined in AGREEMENT.
WHEREAS,
ASAHI recognizes that OCCULOGIX has a potential for selling the Product and
is
applicable as a distributor for the Product in the Territory. ASAHI is desirous
that more Product will be sold in the Territory.
NOW,
THEREFORE, both parties shall confirm and agree to the following:
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1.
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The
Exhibit A of AGREEMENT shall be replaced with the Exhibit A of
this
Memorandum attached hereto.
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2.
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AGREEMENT
shall be amended to include Exhibits B, C and D attached
hereto.
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3.
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The
Paragraph B of the Article 1 of AGREEMENT shall be replaced with
the
following:
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“Territory”
shall mean the countries or areas set forth in the Exhibit B, C and D attached
hereto.
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4.
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The
Paragraph 2.1 of AGREEMENT shall be replaced with the
following:
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1
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2.1.1
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ASAHI
hereby appoints OCCULOGIX as its exclusive distributor in the Territory-1
for the sale of the Product solely used for the Treatment Disease,
provided, however, that OCCULOGIX obtains the FDA approval and
other
necessary approvals in the Territory-1 according to the Article
7.1.1,
7.2, 7.3, 7.4, 7.5, 7.6, and 7.7 of this Agreement. OCCULOGIX agrees
to
act as such exclusive distributor under the terms and conditions
of this
Agreement.
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2.1.2
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ASAHI
hereby appoints OCCULOGIX as its exclusive distributor in the
Territory-2
for the sale of the Product solely used for the Treatment Disease,
provided, however, that OCCULOGIX obtains the necessary approvals
in the
Territory-2 according to the Article 7.1.2, 7.4, 7.5, 7.6, and
7.7 of this
Agreement. OCCULOGIX agrees to act as such exclusive distributor
under the
terms and conditions of this
Agreement.
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2.1.3
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ASAHI
hereby appoints OCCULOGIX as its non-exclusive distributor in
the
Territory-3 for the sale of Product solely used for the Treatment
Disease,
provided, however, that OCCULOGIX obtains necessary regulatory
approvals
in the Territory-3 according to the Article 7.1.3, 7.4, 7.5,
7.6 and 7.7
of this Agreement. OCCULOGIX agrees to act as such non-exclusive
distributor under the terms and conditions of this
Agreement.
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5.
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The
Paragraph 2.4 of AGREEMENT shall be replaced with the
following:
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2.4
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OCCULOGIX
shall not represent, market, or sell any similar to or competitive
products with Product in the Territory-1 and Territory-2 during
the term
of this Agreement.
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6.
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The
Paragraph 2.7 of AGREEMENT shall be replaced with the
following:
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2.7
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OCCULOGIX
shall make its best efforts that public and private medical insurance
reimbursement shall be applied for the Treatment Disease using
the Product
in the Territory-1. Occulogix shall also make the commercially
reasonable
efforts that public and private medical insurance reimbursement
shall be
applied for the Treatment Disease using the Product in the Territory-2
and
Territory-3.
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7.
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The
Paragraph 3.1 of AGREEMENT shall be replaced with the
following:
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3.1.1
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OCCULOGIX
shall purchase the Product from ASAHI in the Territory-1 in not
less than
the quantities described in the Exhibit B attached
hereto.
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2
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3.1.2
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OCCULOGIX
shall purchase the Product from ASAHI in the Territory-2 in not
less than
the quantities described in the Exhibit C attached
hereto.
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3.1.3
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OCCULOGIX
shall make its best efforts to purchase from ASAHI in the Territory-3
the
target quantities of Product described in the Exhibit D attached
hereto:
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8.
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The
Paragraph 7.1 of AGREEMENT shall be replaced with the
following:
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7.1.1
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OCCULOGIX
shall be responsible, at its own costs and expenses, for obtaining
and
maintaining the FDA and all other applicable approvals and validations
for
marketing, sales and use of Product for the Treatment Disease in
the
Territory-1 under the name of ASAHI by the end of December 2006.
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.
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7.1.2
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OCCULOGIX
shall be responsible, at its own costs and expenses, for obtaining
and
maintaining all the applicable approvals and validations for marketing,
sales and use of Product for the Treatment Disease in the Territory-2
under the names of ASAHI by the end of December 2010. If the above
approvals cannot be obtained by such day and year, OCCULOGIX shall
consult
with ASAHI and attempt to reach a mutually acceptable resolution.
Despite
consultation, if both parties cannot find a mutually acceptable
resolution, ASAHI may delete Product from this Agreement, upon
six (6)
months’ prior written notice to OCCULOGIX, for the country or countries
of
the Territory-2 where the above approvals were not
obtained.
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| 7.1.3 |
OCCULOGIX
shall make its best efforts to obtain, with half the costs
and expenses
shared with ASAHI, all the applicable approvals and validations
for
marketing, sales and use of Product for the Treatment Disease
in the
Territory-3 under the name of ASAHI by the end of December
2010. If the
above approvals cannot be obtained by such day and year, OCCULOGIX
shall
consult with ASAHI and attempt to reach a mutually acceptable
resolution.
Despite consultation, if both parties cannot find a mutually
acceptable
resolution, ASAHI may delete Product from this Agreement for
the
Territory-3 upon six (6) months’ prior written notice to
OCCULOGIX.
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3
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9.
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The
Paragraph 7.4 of AGREEMENT shall be replaced with the
following:
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7.4
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OCCULOGIX
shall not be entitled to any compensation from ASAHI even when
OCCULOGIX
may not obtain the regulatory approvals of Product in the
Territory.
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10.
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The
Paragraph 7.7 of AGREEMENT shall be replaced with the
following:
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7.7
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Without
limiting any other provision in this Agreement, OCCULOGIX shall
fully
comply with the regulations of each country in the
Territory.
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11.
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The
Paragraph 8.3 of AGREEMENT shall be replaced with the
following:
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8.3
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OCCULOGIX
shall have a right of first refusal over exclusive and non-exclusive
distribution rights in the Territory-1, the Territory-2, and
the
Territory-3 with respect to the Product for the treatment of
retinopathy
and any other ophthalmic diseases within the scope of hemo-rheological
disorders (other than the Treatment
Disease).
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12.
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The
Paragraph 18.1 of AGREEMENT shall be replaced with the
following:
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18.1
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Each
Territory shall have its own term for the sales right of the
Products.
Details shall be described in the Exhibit B attached
hereto.
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13.
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The
Paragraph 19.3 of AGREEMENT shall be replaced with the
following:
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19.3
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If
OCCULOGIX fails to fulfill the provisions stipulated in the Paragraph
3.1.1 and 3.1.2 of this Agreement, ASAHI may, at its option,
modify the
exclusive right granted to OCCULOGIX hereunder to a non-exclusive
right.
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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:
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Signed
and agreed by
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/s/
Xxxxxxxx Xxxxxxx
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/s/
Xxxxx Xxxxxxxx
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Xxxxxxxx
Xxxxxxx
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Xxxxx
Xxxxxxxx
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President
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Chief
Executive Officer
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ASAHI
KASEI MEDICAL CO., LTD.
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Date:
October 17, 2005
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Date:
October 17, 2005
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5
Exhibit
A
Product
First
filter: Plasmaflo OP-05W(L)
Second
filter: Rheofilter AR-2000, or
new
or
improved Rheofilter which ASAHI designates in writing
Product
means the set of the above first filter and second filter which is used together
for the Treatment Disease.
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/s/
Jun-xxxx Xxxxxxxxx
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Xxx-xxxx
Xxxxxxxxx
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Director
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ASAHI
KASEI MEDICAL CO.,Ltd.
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6
Exhibit
B
Territory
Collectively
the following “Territory-1” in Exhibit B, “Territory-2” in Exhibit C and
“Territory-3” in Exhibit D
Territory-1
United
States of America, Canada, United Mexican States, 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 Xxxxxx, Saint Lucia, Saint Xxxxxxxxxxx and Nevis, Saint Xxxxxxx
and the Grenadines, Caicos Islands, Virgin Islands of the United States of
America
Minimum
purchase requirement:
First
year: 9,000 sets of First and Second filter
Second
year: 15,000 sets of First and Second filter
Third
year: 22,500 sets of 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 Fifth 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.
Term:
OCCULOGIX’
sales right of Product in the Terriroty-1 shall be valid from December 31,
2001,
until ten (10) years after the date of FDA approval of Product for the Treatment
Disease, 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.
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/s/
Xxxxxxxx Xxxxxxx
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/s/
Xxxxx Xxxxxxxx
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Xxxxxxxx
Xxxxxxx
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Xxxxx
Xxxxxxxx
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President
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Chief
Executive Officer
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ASAHI
KASEI MEDICAL CO., LTD.
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Date:
October 17, 2005
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Date:
October 17, 2005
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8
Exhibit
C
Territory-2
Republic
of Colombia, Bolivarian Republic of Venezuela, Australia, New
Zealand
Minimum
purchase requirement:
Republic
of Colombia
Jan.
1,
2006 - Dec. 31, 2006: 0 set of First and Second filter
Jan.
1,
2007 - Dec. 31, 2007: 300 sets of First and Second filter
Jan.
1,
2008 - Dec. 31, 2008: 500 sets of First and Second filter
Bolivarian
Republic of Venezuela
Jan.
1,
2006 - Dec. 31, 2006: 0 set of First and Second filter
Jan.
1,
2007 - Dec. 31, 2007: 300 sets of First and Second filter
Jan.
1,
2008 - Dec. 31, 2008: 500 sets of First and Second filter
Australia
and New Zealand
Jan.
1,
2006 - Dec. 31, 2006: 0 sets of First and Second filter
Jan.
1,
2007 - Dec. 31, 2007: 300 sets of First and Second filter
Jan.
1,
2008 - Dec. 31, 2008: 500 sets of First and Second filter
The
minimum purchase quantities for the year 2009 and 2010 shall be discussed
and
determined at the beginning of the year 2008 by mutual consent, but shall
not be
less than each of the previous year.
Term:
OCCULOGIX’
sales right of Product in the Terriroty-2 shall be valid from EFFECTIVE DATE
through December 31, 2010.
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/s/
Xxxxxxxx Xxxxxxx
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/s/
Xxxxx Xxxxxxxx
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Xxxxxxxx
Xxxxxxx
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Xxxxx
Xxxxxxxx
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President
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Chief
Executive Officer
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ASAHI
KASEI MEDICAL CO., LTD.
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Date:
October 17, 2005
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Date:
October 17, 2005
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9
Exhibit
D
Territory-3
Republic
of Italy
Target
purchase quantity:
Republic
of Italy
Jan.
1,
2006 - Dec. 31, 2006: 200 sets of First and Second filter
Jan.
1,
2007 - Dec. 31, 2007: 500 sets of First and Second filter
Jan.
1,
2008 - Dec. 31, 2008: 1,000 sets of First and Second filter
The
target purchase quantities for the year 2009 and 2010 shall be discussed
and
determined at the beginning of the year 2008 by mutual consent.
Term:
OCCULOGIX’
sales right of Product in the Terriroty-3 shall be valid from EFFECTIVE DATE
through December 31, 2010.
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/s/
Xxxxxxxx Xxxxxxx
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/s/
Xxxxx Xxxxxxxx
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Xxxxxxxx
Xxxxxxx
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Xxxxx
Xxxxxxxx
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President
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Chief
Executive Officer
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ASAHI
KASEI MEDICAL CO., LTD.
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Date:
October 17, 2005
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Date:
October 17, 2005
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