Contract
This
Agreement made and entered into on October the 20th, 2006
(hereinafter called “Effective
Date”),
by
and between Asahi Kasei Medical Co., Ltd. (changed its name from Asahi Medical
Co., Ltd. in 2004), a corporation organized and
existing under the laws of Japan, with its principal place of business 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 a place of business at 000 Xxxxxxx Xxxxxx, Xxxx Xxxxxx,
Xxxxxxx 00000, the United States of America (hereinafter called
“OCCULOGIX”):
WITNESSETH
WHEREAS,
ASAHI
and
Apheresis Technologies, Inc. (“ATI”)
entered into, on February
1,
1997, the “1997
Distributorship Agreement” which had been amended by the “Memorandum” dated
April 1, 1998, the “Amendment to 1997 Distributorship Agreement and Plasmaflo
Agreement” dated January 1, 1999, the “2000 Agreement” dated September 1,
2000
and the
“Second
Amendment to 1997 Distributorship Agreement and Plasmaflo Agreement” dated
November 1, 2000 (such amended Distributorship Agreement shall be hereinafter
called “1997-DA”).
As
OccuLogix Corporation (“OLC”)
had
split off ATI and succeeded to
ATI’s
business relating to the product for the Treatment Disease (as defined in the
1997-DA) on December 31, 2001, ASAHI, OLC and ATI made, on the same date, the
“Memorandum” to terminate the 1997-DA and to enter into a new distributorship
agreement. Under
such
Memorandum, ASAHI and OCCULOGIX (which had been assigned the below 2001-DA
by
OLC with ASAHI’s
consent to such assignment under the “Consent To Assignment Of Contract” dated
July 25, 2002 and changed its name from Vascular Sciences Corporation
in
2004)
entered into, on December 31, 2001, the “Distributorship
Agreement”, which has been amended by the “2003 Memorandum” dated October 30,
2003, the “2004 Memorandum” dated July 28, 2004 and the “2005 Memorandum” dated
October 17, 2005 (such amended Distributorship
Agreement shall be hereinafter
called “2001-DA”);
WHEREAS,
since
July 2, 1999, OCCULOGIX (ATI before said assignment in 2002) has been carrying
out the clinical trial for obtaining the FDA (hereinafter defined) approval
and
validation to market,
sell
and use the product of the set of the first filter “Plasmaflo
OP-05W(L)” and the second filter “Rheofilter AR-2000” for the disease of an
age-related macular degeneration in the United States of America and, after
such
execution date, shall be responsible,
at its own costs and expenses, for obtaining the FDA approval and
validation
by use
of such clinical trial (hereinafter called “MIRA-1”)
pursuant to Article 7.1.1 of the 2001-DA;
WHEREAS,
on
February 3, 2006, OCCULOGIX announced “MIRA-1
did not demonstrate a statistically significant difference in the mean change
of
Best Spectacle-Corrected Visual Acuity applying the Early Treatment Diabetic
Retinopathy Scale between the treated and placebo groups at 12-months
post-baseline. As expected, the treated group demonstrated a positive response.
An anomalous response of the control group is the principal reason that the
primary efficacy endpoint was not met.”
Because
such announcement has made it unlikely that the FDA approval and validation
using the MIRA-1
data
will
be obtained (as set forth in Article 7.1.1 of the 2001-DA), it is necessary
for
OCCULOGIX to consult with ASAHI and attempt to reach a mutually acceptable
resolution;
WHEREAS,
at the
April 25, 2006 Tokyo meeting among ASAHI, OCCULOGIX and Diamed
Medizintechnik GmbH,
it was
decided among them that, as the result of reviewing MIRA-1, OCCULOGIX would
try
again the clinical trial under support of ASAHI by new agreement form, and
considered it expedient to decide that the second filter would be changed
from “Rheofilter
AR-2000” to “Rheofilter SR-20” because the production of Rheofilter AR-2000
would be planned to cease in 2008 and Rheofilter SR-20 has already come onto
the
EU market in February of 2006; and
WHEREAS,
ASAHI
and OCCULOGIX desire to make
such
new agreement, together with the termination of the 2001-DA.
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 set of the first filter and second filter,
which
are always used
together for the Treatment Disease and
which
are set forth in Exhibit
A
attached
hereto.
B. “Territory”
shall
mean the countries or areas consisting of (i) “Territory-1a”
(as
defined in Exhibit
B
attached
hereto), (ii) “Territory-1b”
(as
defined in Exhibit
C
attached
hereto),
(iii) “Territory-2”
(as
defined in Exhibit
D
attached
hereto) and (iv) “Territory-3”
(as
defined in Exhibit
E
attached
hereto).
C. “Distribution
Period-1a”
shall
mean the period from the Effective Date until ten (10) years after the
date
of obtaining the FDA Approval, which may
be
renewed for additional and
successive
one (1) year periods, unless ASAHI or OCCULOGIX gives the other written notice
of its intention not to renew at least six (6) months prior to the expiration
date thereof.
D. “Distribution
Period-1b”
shall
mean the period from the Effective Date until ten (10) years after the date
of
obtaining the Health Canada Approval for the second filter (as set forth in
Exhibit
A
attached
hereto), which may be renewed for additional
and
successive one (1) year periods,
unless ASAHI or OCCULOGIX gives the other written notice of its intention
not to renew at least six (6) months prior to the expiration date
thereof.
E. “Distribution
Period-2”
shall
mean the period from the Effective Date
through
December 31, 2010.
F. “Treatment
Disease”
shall
mean age-related macular degeneration.
G. “FDA”
shall
mean the Federal Food and Drug Administration in the
U.S.A.
H. “Health
Canada”
shall
mean the Federal department of health in Canada.
I.
“Approval”
shall
mean the regulatory approval and validations to market, sell and use the Product
for the Treatment Disease.
J.
“OCCULOGIX”
shall
also include its affiliate companies, which are the organizations that are
more
than fifty percent (50%) owned or
controlled by OCCULOGIX.
Notwithstanding
anything to the contrary contained in this Agreement, such affiliate companies
may market, sell and distribute any Product in the Territory subject to ASAHI’s
prior approval in writing.
K. “SPC”
shall
mean the special
purpose company,
which
ASAHI and OCCULOGIX will, before the FDA Approval is obtained hereunder,
establish as the following new corporation
under the laws of the State of Delaware, the United States of
America.
(a) Purpose
of Business: to own and control
all
rights of the obtained FDA Approval (PMA ownership) transferred from OCCULOGIX
pursuant to Article 7.1.1 hereof
(b) Ratio
of
Capital Contribution: 51% for ASAHI and 49% for OCCULOGIX
The terms and conditions of establishment of SPC, including without
limitation corporate name, kind
of
share, total number of issue (Authorized Capital), par value of one
share,
total number of issue at establishment (Initial Paid-in Capital) and
location of registered office, will be separately agreed upon by ASAHI and
OCCULOGIX.After
establishing the
SPC, ASAHI and OCCULOGIX will make the SPC entrust OCCULOGIX to carry out the
business subject to the terms and conditions separately agreed upon by ASAHI
and
OCCULOGIX. Additionally, ASAHI may at its discretion dispatch its
employee to OCCULOGIX
relating to such business.
ARTICLE
2. DISTRIBUTORSHIP
2.1
Distributorship
in the Territory:
2.1.1 Territory-1a:
During
the Distribution Period-1a, ASAHI hereby appoints OCCULOGIX as its exclusive
distributor in the Territory-1a for the sale of the Product solely used for
the
Treatment
Disease, provided, however, that OCCULOGIX obtains the FDA and other necessary
Approvals in the Territory-1a according to Articles 7.1.1 and 7.2 through 7.7
hereof
OCCULOGIX agrees to act as such
exclusive distributor under the terms and conditions of this
Agreement.
2.1.2 Territory-1b:
During
the Distribution Period-1b, ASAHI hereby appoints OCCULOGIX as its exclusive
distributor in the Territory-1b for the sale of the Product solely used for
the
Treatment
Disease, provided, however, that OCCULOGIX
obtains the Health Canada Approval in the Territory-1b according to Articles
7.1.2 and 7.3 through 7.7 hereof. OCCULOGIX
agrees to
act as
such exclusive distributor under the terms and conditions of this
Agreement.
2.1.3
Territory-2:
During
the Distribution Period-2, 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 Articles 7.1.3 and 7.3
through 7.7 hereof. OCCULOGIX agrees
to act as
such
exclusive distributor under the terms and conditions of this
Agreement.
2.1.4
Territory-3:
During
the Distribution Period-2, 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 the necessary Approval in the
Territory-3 according to Articles 7.1.4
and
7.3 through 7.7 hereof.
OCCULOGIX agrees to
act as
such
non-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 During
the term of this Agreement, OCCULOGIX shall not represent, market, or sell
any
product
similar to or competitive with the Product in the Territory (excluding
Territory-3).
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
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
(excluding Territory-3).
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-3.
ARTICLE
3. MINIMUM AND TARGET PURCHASE REQUIREMENT
3.1
Minimum
and Target Purchase in the Territory:
3.1.1
Territory-1a:
OCCULOGIX
shall purchase from ASAHI the Product in the Territory-1a in not less than
the
quantities described in Exhibit
B
attached
hereto.
3.1.2
Territory-1b:
OCCULOGIX
shall purchase from ASAHI the Product in the Territory-1b in not less
than
the
quantities described in Exhibit
C
attached
hereto.
3.1.3
Territory-2:
OCCULOGIX
shall purchase from ASAHI the Product in the Territory-2 in not less than the
quantities described in Exhibit
D
attached
hereto.
3.1.4
Territory-3:
OCCULOGIX
shall make
its best
efforts to purchase from ASAHI the Product in the Territory-3 in the target
quantities described in Exhibit
E
attached
hereto.
3.2
For
the
purpose of this Article 3, the Product shall be considered purchased when the
Product have actually been delivered
in
accordance with Article 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 agrees not to unreasonably
reject any order placed by OCCULOGIX
to satisfy its minimum purchase obligations of Product (as set forth in Article
3 above). 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 Article 4.3, a delayed and/or partial shipment shall be accepted by
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
Article 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
the
provision of Article 2.4 of this Agreement, OCCULOGIX may purchase product(s)
competitive
with
Product from a third party
with
prior written consent of ASAHI; provided, however, that such 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.
4.6
The
delivery of the Product shall be at the loading port in Japan on the basis
of
“FOB”
as
defined in the
latest INCOTERMS, and the parties’
respective obligations shall be determined in accordance with the
latest INCOTERMS.
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
or
circumstances that are proximately caused by causes, events or circumstances
beyond ASAHI’s
control;
and
provided, further, that,
if
any of
the circumstances described in (a), (b) or (c) above ceases to exist, then
the
price of any product exceeding 120% of the preceding calendar year’s
price
shall be lowered to 120% of the preceding calendar year’s price.
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 Xxxx 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 this Article 5 shall be made in the currency of U.S. dollars.
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 has been handed over to
the
carrier or to another person acting on his behalf as defined in the
latest INCOTERMS. 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
Approval
in the Territory:
7.1.1
Territory-1a:
OCCULOGIX
shall be responsible,
at
its own costs and expenses, for (i)
submitting applications to obtain the FDA Approval and all other necessary
Approvals in the Territory-1a, (ii) carrying out the clinical trial for such
Approvals, (iii) obtaining such Approvals, and thereafter (iv)
transferring
to
(a) the SPC all rights of such obtained FDA Approval and (b) ASAHI all rights
of
such obtained other Approvals, by the date of December 31, 2010. If any of
the
above Approvals cannot be obtained by such date, 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, upon six (6)
months’
prior
written notice to OCCULOGIX,
delete the product (of the Product), which
needs
such Approval respectively.
7.1.2
Territory-1b:
OCCULOGIX
shall be responsible, at its own costs and expenses, for (i) submitting an
application to obtain the Health Canada Approval in the Territory-1b, (ii)
carrying out the clinical trial for such
Approval,
(iii) obtaining such Approval, and thereafter (iv) transferring to ASAHI all
rights of such obtained Approval, by the date of February
28, 2009.
If such
Approval cannot be obtained by such date, 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, upon six (6) months’
prior
written notice to OCCULOGIX,
delete the product (of the Product), which needs such Approval.
7.1.3
Territory-2:
OCCULOGIX
shall be responsible, at its own costs and expenses, for (i) submitting
applications to obtain all necessary Approvals in the Territory-2, (ii) carrying
out the clinical trial for such Approvals, (iii) obtaining such Approvals,
and
thereafter (iv) transferring
to
ASAHI all rights of such obtained Approvals, by the date of December 31, 2010.
If any of the above Approvals cannot be obtained by such date, 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, upon six (6) months’
prior
written notice to OCCULOGIX,
delete the product (of the Product), which needs such Approval
respectively.
7.1.4
Territory-3:
OCCULOGIX
shall make its best efforts to, with half the costs and expenses shared with
ASAHI, (i) submit an application to obtain all necessary Approval in the
Territory-3, (ii) carry out the clinical trial for such Approval, (iii) obtain
such Approval, and thereafter (iv) transfer to ASAHI all rights of such obtained
Approval with co-copyrights of clinical data gained from such clinical trial,
by
the date of December 31, 2010. If such Approval cannot be obtained by such
date,
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, upon six (6)
months’
prior
written notice to OCCULOGIX,
delete the product (of the Product), which
needs
such Approval.
7.2
FDA
Application and Approval:
7.2.1
In
the
course of the FDA application, OCCULOGIX shall fully comply with the schedule
set forth in Exhibit
F
attached
hereto.
7.2.2
OCCULOGIX
shall send ASAHI the documents for submissions to FDA (Investigational
Device Exemption (“IDE”)
application, Pre-market Approval (“PMA”)
application, other submissions to FDA, analysis of clinical data, materials
used
for FDA meeting, etc.) for ASAHI’s review, before submitting to
FDA.
7.2.3 ASAHI
shall bear and pay to OCCULOGIX, as a part
of
costs of the clinical trial for FDA application, (i) Two Million United States
Dollars (US$ 2,000,000) within sixty (60) days after the later to occur of
(a)
receipt by OCCULOGIX of IDE approval in connection with such
clinical
trial
and (b)
the raising of a minimum of Fifteen Million United States Dollars (US$
15,000,000) by OCCULOGIX for purposes of supporting its corporate
diversification strategy, in addition to the issuance
of 8,399,983
shares
of
OCCULOGIX for the acquisition
of Solx,
and
(ii) One Million United States Dollars (US$ 1,000,000) within sixty (60) days
after the completion of 50% of subject enrollment of the clinical trial for
the
FDA Approval, provided that:
(a) OCCULOGIX
shall allow:
(a1) ASAHI
to
review
(i)
FDA application procedure (IDE application, PMA application, clinical data
analysis, FDA meeting, etc.),
(ii)
clinical trial site audits and (iii)
technical instructions provided by OCCULOGIX to clinical trial sites,
within ASAHI’s sole discretion;
(a2) ASAHI
to
dispatch ASAHI’s
employees in order to execute (a1) above, within ASAHI’s sole
discretion;
(a3) ASAHI
to
participate in decision making on the FDA application, however OCCULOGIX shall
have the right to make final decision as far as reasonable;
(a4) ASAHI
to
participate in the sponsor’s
audits
of clinical trial sites, within ASAHI’s sole discretion; and
(a5) itself
and the clinical trial sites to be audited by Japanese Ministry of Health,
Labour and Welfare (“JMHLW”)
for
ASAHI’s application
to
obtain
the JMHLW
Approval in Japan at ASAHI’s cost; and
(b) ASAHI
and
OCCULOGIX shall own jointly copyrights of all clinical data used for the FDA
application, provided that OCCULOGIX may use such clinical data in the
Territory and that ASAHI may use such
clinical data in and outside
the
Territory; and
provided, further, that: in
the
event that it is difficult or impossible to obtain the
FDA Approval
or
in
the
event of occurrence
of the events
set
forth in Article 19.1 (a)
below, OCCULOGIX agrees to
transfer
to Asahi all of its rights in the SPC as well as
its
trademarks
rights used
in
connection with the Product (e.g.
RHEO, RHEO
CLINIC and RHEOPHERESIS) and
other
intellectual property rights (including any patents
rights other than US patent right of US 6,245,038 B1) in connection with
rheopheresis, any and all copyright it may have in
the
clinical data used for the FDA application
and
its
applicant right of FDA approval (FDA sponsorship).
7.2.4 ASAHI
shall, free of charge, supply and ship to OCCULOGIX up to 3,000 sets of the
Product for
the
clinical trial to obtain the FDA Approval; provided, however, that:
(a) OCCULOGIX
shall inform ASAHI
of
the quantity of Product necessary in order to carry out such
clinical trial and the time by which OCCULOGIX requires sets of the Product
to
be shipped;
(b) the
expenses of shipment of said Product shall be borne by OCCULOGIX;
and
(c) if
OCCULOGIX’s needs
exceed
said 3,000 sets of Product, ASAHI may, at its discretion, supply Product at
the
price stipulated in ASAHI’s latest price list.
7.3
OCCULOGIX
shall inform ASAHI of the documentation necessary for the FDA, Health Canada
and
other Approvals. Upon
OCCULOGIX’s
request, ASAHI
shall make its
best efforts to provide technical data relating to the Product that is within
ASAHI’s
access.
7.4
OCCULOGIX
shall not be entitled to any compensation from ASAHI even when OCCULOGIX may
not
obtain any Approvals in
the
Territory.
7.5
Other
than pursuant to Articles 7.1.4 and 7.2.3 or as may be agreed otherwise by
ASAHI
and OCCULOGIX, OCCULOGIX shall not be entitled to any reimbursement
from
ASAHI of costs and expenses incurred by OCCULOGIX in connection with the
pursuit
of
Approvals.
7.6
OCCULOGIX
shall endeavor to obtain, at its own expenses and in accordance with the
schedule set forth in Articles 7.1.1 to 7.1.4 inclusive, the FDA, Health Canada
and
other necessary regulatory approvals and validations for the accessories
of
the Product
in the Territory, such as blood pump or tubing set, which may be required for
the
treatment
of the Treatment Disease using the Products.
7.7
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 called “S.O.P.”).
7.8 Without
limiting any other provision in this Agreement, OCCULOGIX shall fully comply
with the regulations of each country in the Territory.
ARTICLE
8.
SUPPLY AND FIRST REFUSAL RIGHT
8.1
During
the
term of this Agreement after OCCULOGIX obtains the FDA, Health Canada and other
necessary Approvals, ASAHI shall continue to supply the Product to
OCCULOGIX subject to the provisions in Article 4.3; provided,
however, that, in the following events, 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 the Product:
(a) if
due to
the decrease in the demand
of
any of the Product, the exchange rate situation, or price of raw materials,
ASAHI
cannot economically manufacture or supply
Product, or
(b) if
due
to
the special circumstances, such as patent infringement liability or product
liability issues relating
to
the Product or the treatment using the Product, ASAHI
cannot manufacture
or supply Product, or
(c) if
ASAHI
develops an improved product which may be used in place of any of the Product
and ASAHI cannot economically manufacture or supply the Product.
In
the
event that any of the above circumstances arises, 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 the
Product without any compensation or other obligation to OCCULOGIX and, in the
event of the (a) or (b)
circumstance,
OCCULOGIX
may,
notwithstanding the provision of Article 2.4 hereof, purchase competitive
product(s) with such Product from a third party with prior
written
consent of ASAHI.
8.2
In
the
event of the circumstance of Article
8.1 (c) above, OCCULOGIX may have the first
refusal
right to obtain the distribution rights of the
improved product set forth in
Article 8.1 (c) solely used for the Treatment Disease in the Territory
under the terms and conditions by mutual consent, provided that OCCULOGIX bears
the costs and
expenses
relating to necessary
Approvals of such improved product for the Treatment Disease in the
Territory.
8.3
OCCULOGIX
shall
have a right of first refusal over exclusive and non-exclusive distribution
rights in the
Territory with respect to the Product for
the
treatment
of the
ophthalmic diseases (other than the Treatment Disease) under the terms and
conditions by mutual consent, provided that OCCULOGIX bears the costs and
expenses relating
to necessary for Approvals of the Product for the treatment of such
ophthalmic diseases in
the
Territory.
ARTICLE
9. WARRANTY
9.1
If
any
Product is in a damaged condition upon its delivery to OCCULOGIX, or the
quantity 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 shortfall or damage. ASAHI shall replace such damaged Product and/or
remedy such shortfalls, 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 shortfall 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 shortfall claims
against
ASAHI.
9.2
ASAHI
warrants exclusively to OCCULOGIX and to no other person, firm or corporation
that each of the 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 Article 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 Article
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 direct or indirect customers, 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
OR 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
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 xxxx, 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 xxxx, 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 shall thereupon 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
expiration
or
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
For
greater certainty, for purposes of this Agreement, the term “Trademark” shall
not be interpreted to include any trademarks obtained by OCCULOGIX not in
violation of this Agreement (including, without limitation, “RHEOPHERESIS” and
“RHEO CLINIC”), notwithstanding any prior written consent that may have been
granted by ASAHI to OCCULOGIX pursuant to Article
10.1 to use any such trademarks in connection with the distribution of the
Product. With
respect to “RHEO” obtained by OCCULOGIX, ASAHI and OCCULOGIX shall own jointly
its right in trademark.
10.6
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 expiration or termination of this Agreement.
10.7
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.
10.8
In
the
event that
OCCULOGIX
has or obtains any intellectual property right relating to the Treatment Disease
using Product (including without limitation the patents set forth in
Exhibit
G
attached
hereto), ASAHI shall have the first refusal right to obtain from OCCULOGIX
a
non-exclusive right and license to use or
practice such intellectual property right for manufacture, sell and use of
Product, (i) within the Territory-3 and outside the Territory during the term
of
this Agreement and thereafter, and (ii) within the Territory
(excluding
Territory-3) after expiration or termination of this Agreement pursuant to
Article 18.1 or 19.1 or after the conversion into non-exclusive right pursuant
to Article 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 obtaining the
FDA, Health Canada and other necessary Approvals, during the clinical trial
and
until such Approvals are obtained. OCCULOGIX 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 Article 7 quarterly
within thirty (30) days after the end of previous quarter. It is expressly
understood that OCCULOGIX shall fully comply with the M.D.R. (Medical
Device
Reporting)
Regulation and with the S.O.P. even during such clinical trial.
14.2
In
addition to the reports to be provided by OCCULOGIX to ASAHI pursuant to Article
4.1 of this Agreement, OCCULOGIX shall provide Asahi, on annual basis, the
annual financial
statements of OCCULOGIX.
As used herein, the phrase “annual
financial statements”
shall
refer to the income statement, balance sheet and supporting schedules audited
by
the Certified Public Accountant for OCCULOGIX for each fiscal year end of
OCCULOGIX.
Such
financial statements 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 their public
release.
ARTICLE
15.
CONFIDENTIALITY
During
the term of this Agreement and five (5) years thereafter, or ten (10) years
after the Effective Date, 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 as may be required by law and 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. 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 Force Majeure,
which
means 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, 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 the above Force Majeure shall
relieve OCCULOGIX of its obligation to make any payment hereunder.
ARTICLE
17. ASSIGNMENT
OCCULOGIX
shall not 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
The
term
of this Agreement shall be effective on the Effective Date and remain in effect
until all of the Distribution Period-1a, the Distribution Period-1b and the
Distribution Period-2 expire or terminate.
18.2
Notwithstanding
the foregoing of Article 18.1 above, the
provisions of Articles 9, 10, 13, 15, 19.2, and 23 shall survive any expiration
or termination of this Agreement.
ARTICLE
19. TERMINATION
19.1
Subject
to Article 19.3, 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 a 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 Articles 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
(d) if
a
competitor
(an individual or entity that competes with ASAHI in the business of the
Products) takes control of the management or acquires a majority of the voting
shares of OCCULOGIX that 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 Articles 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 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. Simultaneously with
expiration
or
termination of this Agreement, OCCULOGIX
shall,
at its initial capital contribution payment free of interest, transfer to ASAHI
its all shares of SPC. 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 for Product already ordered and shipped shall become due. For greater
certainty, if this Agreement or any individual contract for the purchase
of
Product hereunder is terminated, then OCCULOGIX shall have no obligation to
purchase the balance of any minimum purchase quantities then outstanding under
this Agreement or to purchase any Product that is subject to the terminated
individual contract, respectively.
19.3
If
OCCULOGIX fails to fulfill any of the obligations stipulated in Articles 3.1.1
through 3.1.3 of this Agreement, ASAHI may, at its option, convert or modify
OCCULOGIX’s
exclusive distributorship status to that of a non-exclusive distributor in
the
Territory-1a (in the case of a breach of Article 3.1.1), in the Territory-1b
(in
the case of a breach of Article 3.1.2) and in the Territory-2 (in the case
of a
breach of Article 3.1.3). For greater certainty, a failure on the part of
OCCULOGIX to fulfill any of the obligations stipulated in Articles 3.1.1 through
3.1.3 of this Agreement shall not give rise to a right of ASAHI to terminate
this Agreement and/or any individual contract of the Product
hereunder.
19.4
OCCULOGIX
may
forthwith
terminate this Agreement
without any compensation to Asahi by giving a written notice of termination
to
Asahi, if Asahi is unable to supply to OCCULOGIX all of the Product under
Article 8.1 above.
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 Exhibits contain the entire agreement of the parties with
respect to
the
subject matter herein contained and supersede any prior agreements
or understandings between the parties except the S.O.P. and “2006 Memorandum for
Rheofilter AR-2000” dated xxxx xx, 2006 between the parties. It is understood
and confirmed that the
parties
agree to terminate the 2001-DA on the Effective Date, provided, however, that
any rights and obligations of each party with respect to the Product (as defined
in the 2001-DA), which OCCULOGIX had purchased
from ASAHI before the Effective Date under
the
2001-DA,
shall
survive after the Effective Date in accordance with the applicable provisions
of
the 2001-DA.
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 hereof, 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.
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 be
indicated in writing by the parties hereto by notice pursuant to this Article
24. If either party has changed its address,
a
written notice thereof shall be given to the other party pursuant to this
Article
24.
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 the
Effective Date.
Xxxxx
Xxxxxxxx
Xxxxxxxx
Xxxxxxx
Chairman
and
Chief Executive
Office
President
OccuLogix,
Inc.
Asahi
Kasei Medical Co., Ltd.
Date:
October
20,
2006
Date:
October 20, 2006
Exhibit
A
The
Product shall mean the sets of the following First filter and Second filter,
which are always used together for the Treatment Disease.
(a) “First
filter”
means
Plasmaflo OP-05W(L).
(b) “Second
filter”
means
Rheofilter SR-20.
Exhibit
B
B-1.
“Territory-1a”
means:
United
States of America, 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 and Virgin Islands of the United States of America.
B-2.
Minimum
purchase
requirement:
The
following minimum purchase quantities shall be effective from six (6) months
after OCCULOGIX obtains the FDA Approval.
First
year: 9,000 sets
Second
year: 15,000 sets
Third
year: 22,500 sets
Fourth
year and thereafter: The minimum purchase quantities for the Fourth year shall
be discussed and determined immediately after 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.
Exhibit
C
C-1.
“Territory-1b”
means
Canada.
C-2. Minimum
purchase requirement:
First
year: 900
sets
Second
year: 1,500 sets
Third
year: 2,250 sets
Fourth
year and thereafter: The minimum purchase quantities for the Fourth year shall
be discussed and determined immediately after 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.
The
First
year period referred to above shall commence upon the earlier to occur of (a)
the sale out by OCCULOGIX of its current inventory of the Rheofilter AR-2000
and
(b)
the
expiration of OCCULOGIX’s
current
inventory of the Rheofilter AR-2000.
Exhibit
D
D-1.
“Territory-2”
means
Republic of Colombia, Bolivarian Republic of Venezuela, Australia and New
Zealand.
D-2. Minimum
purchase requirement:
Republic
of Colombia
Jan.
1,
2006 - Dec. 31, 2006: 0 set
Jan.
1,
2007 - Dec. 31, 2007: 0 set
Jan.
1,
2008 - Dec. 31, 2008: 0 set
Jan.
1,
2009 - Dec. 31, 2009: 300 sets
Jan.
1,
2010 -
Dec.
31, 2010: 500 sets
Bolivarian
Republic of Venezuela
Jan.
1,
2006 - Dec. 31, 2006:
0
set
Jan.
1,
2007 - Dec. 31, 2007: 0 set
Jan.
1,
2008 - Dec. 31, 2008: 0 set
Jan.
1,
2009 - Dec. 31, 2009: 300 sets
Jan.
1,
2010 -
Dec.
31, 2010: 500 sets
Australia
and New Zealand
Jan.
1,
2006 - Dec. 31, 2006: 0 set
Jan.
1,
2007 - Dec. 31, 2007:
0
set
Jan.
1,
2008 - Dec. 31, 2008: 0 set
Jan.
1,
2009 -
Dec.
31, 2009: 300 sets
Jan.
1,
2010 -
Dec.
31, 2010: 500 sets
Exhibit
E
E-1. “Territory-3”
means
Republic of Italy.
E-2. Target
purchase quantity:
Jan.
1,
2006 - Dec. 31, 2006: 0
sets
Jan.
1,
2007 -
Dec.
31, 2007: 200
sets
Jan.
1,
2008 - Dec. 31, 2008: 500
sets
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.
Exhibit
F
Schedule
for obtaining
FDA
Approval:
| · |
Filing
of FDA IDE: November, 2006
|
| · |
Start
of patient enrollment: January,
2007
|
| · |
Finish
of patient enrollment: April, 2008
|
| · |
Final
patient follow-up visit: March,
2009
|
| · |
PMA
application submission: September,
2009
|
Exhibit
G
Patents
List:
US
6,245,038B1
US
6,551,266B1
