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FORM: JANUARY 2004
EXHIBIT 10.12
PLANOVA(TM) SALES AGREEMENT
THIS PLANOVA SALES AGREEMENT is made as of 1 day of March, 2004 by
and between
OMRIX BIOPHARMACEUTICALS LTD., an Israeli corporation with a
principal place of
business at the NDA Building, Tel-Hashomer, Israel ("PURCHASER"),
and Asahi
Kasei Pharma Corporation, a Japanese corporation with a principal
place of
business at 9-1, Kanda [ILLEGIBLE], Chiyoda-ku, Tokyo 101-8481,
Japan
("ASAHI").
RECITALS
A. Asahi has developed and currently manufactures Planova (as
defined in Section
1.4), and has in addition obtained certain patents and developed
certain secret
processes, Technologies and other related proprietary know-how
constituting the
Filter Technology (as defined in Section 1.1).
B. Purchaser desires to purchase from Asahi, and Asahi is willing
to sell to
Purchaser, Planova in sufficient quantities to meet Purchaser's
requirements for
evaluating Planova's compatibility with Purchase's manufacturing
process for
Purchaser's Products (as defined in Section 1.5) and/or for
manufacturing
Purchaser's Products to be used for clinical trials to be carried
out by
Purchaser and or sold commercially by Purchaser.
C. Purchaser desires to obtain from Asahi, and Asahi is willing to
grant to
Purchaser, subject to the terms and conditions set forth in this
Agreement, a
license permitting Purchaser to use the Filter Technology solely
for the purpose
set forth in Recital B above.
TERMS OF AGREEMENT
1
DEFINITIONS.
As used in
this Agreement, the following terms shall have the following
meanings,
whether used in the plural or singular form:
1.1 "Filter
Technology" shall mean (i) those secret and proprietary
concepts,
inventions, discoveries, developments, processes, methods,
techniques,
systems
and know-how of Asahi existing on the date of this Agreement or
acquired
thereafter by Asahi which are disclosed to Purchaser directly
or
indirectly
by Asahi orally (provided it has been reduced to writing within
14 days of
disclosure), in writing, through visit to facilities or by any
other
means of transmission, at any time, whether before or after
execution
of this Agreement, including, but not limited to, [ILLEGIBLE]
pertaining
to the evaluation of the compatibility of Planova with
Purchaser's manufacturing process of Purchaser's Products or to the
use of
Planova in
the manufacture of Purchaser's Products, regardless of whether
protectable under any patent, copyright or trade secrets laws, and
(ii)
the
Patents; including, for purpose of the foregoing clause (i), each
item
of
information or data (in whatever form or format:, and regardless of
the
author or
developer thereof) comprising or
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FORM: JANUARY 2004
relating
to any of the following:
1.1.1 any
blueprints, specifications, operating, requirements or
parameters, descriptions, drawings, designs or diagrams relating
to
Planova or
other Asahi products, or prototypes thereof, and
1.1.2 any
research, testing or evaluation results or reports of Asahi
relating
to Planova or other Asahi products, or prototypes thereof, and
any
related sales or cost data or marketing or production
information
(whether
actual or projected), but in any event subject to the
restrictions, exceptions and other terms of Section 11.
1.2
"INCOTERMS/2000" shall mean the version of INCOTERMS adopted by
the
International Chamber of Commerce effective January 1, 2000, but
excluding
any
amendments thereof not specifically agreed to by the parties by
written
agreement in the manner provided for in Section 12.6.
1.3 "Patents"
shall mean those patents listed in Exhibit A, and any other
patents of
Asahi which Asahi may agree, by written notice to Purchaser, to
include as
"Patents" hereunder.
1.4 "Planova"
shall mean (i) filtration products employing Bemberg
Microporous
Membrane
developed and manufactured by Asahi and marketed under the
trade-name
"Planova" ("PLANOVA FILTERS") which are described in SCHEDULE 1
attached
hereto and any improvements thereof, and (ii) Integrity Test
Solution Kit and
any other related accessories and equipment to be used
with or
for Planova Filters which Asahi may from time to time add by
writing
notification to Purchaser ("PLANOVA RELATED PRODUCTS").
1.5 "Purchaser's
Products" shall mean therapeutic or other protein products
derived
from body tissue, plasma, hybridomas or other source materials,
or
by
recombinant means.
1.6 "Purchaser's
Information" shall mean those secret and proprietary
concepts,
inventions, discoveries, developments, processes, methods,
techniques, systems and know-how of Purchaser existing on the date
of this
Agreement
or acquired thereafter by Purchaser which are disclosed to
Asahi
directly
or indirectly by Purchaser orally (provided it has been reduced
to writing
within 14 days of disclosure), in writing, through visit to
facilities
or by any other means of transmission, at any time, whether
before or
after execution of this Agreement, and which pertain to
Purchaser's Products
or to the manufacture of Purchaser's Products,
regardless
of whether protectable under any patent, copyright or trade
secrets
laws, including each item of information or data (in whatever
form
or format,
and regardless of the author or developer thereof) comprising
or
relating to any of the following:
1.6.1 any
blueprints, specifications, operating requirements or
parameters, descriptions, drawings, designs or diagrams relating
to
Purchaser's Products, and
1.6.2 any
research, testing or evaluation results or reports relating to
Purchaser's Products, and any related sales or cost data or
marketing or
production
information (whether actual or projected), but in any
[ILLEGIBLE] subject to the restrictions, exceptions and other terms
of
Section
[ILLEGIBLE].
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FORM: JANUARY 2004
1.7 "Term" shall
mean the period during which Purchaser shall have the right
to place
purchase orders under this Agreement, as provided in and
subject
to the
terms of Section 10.
2
QUARTERLY ESTIMATES.
Purchaser
shall provide Asahi, during the first month of each calendar
quarter in the Term, with Purchaser's written estimates of its
probable
requirements for Planova expected to the ordered in each of the
four calendar
quarters following the quarter in which the estimates are to be
provided in
accordance with the format separately submitted from time to time
by Asahi to
Purchaser. It is understood, however, that none of such estimates
shall be
binding on either party.
3
PRICES AND PAYMENT TERMS.
3.1 SALES
PRICES.
Sales
prices of Planova shall be described in the price lists to be
submitted by Asahi from time to time to Purchaser. Asahi shall
submit the price
lists at least three (3) months before such price lists become
effective.
3.2 PAYMENT
TERMS.
All payment by Purchaser to Asahi shall be due and payable in
advance, in full
in Japanese Yen or in the currency agreed by Purchaser and Asahi,
by telegraphic
transfer to Asahi's following bank account, or such other account
as Asahi may
specify from time to time by notice to Purchaser. Each such payment
shall be
made in accordance with the terms of Section.
The bank
name: Sumito no Mitsui Banking Corporation, Tokyo Main Office
The bank
address: 3-2. Marunouchi [ILLEGIBLE] -chome, Chiyoda-ku, Tokyo
100-0005,
Japan
Swift code
SMBCJPJT
Account #:
207012
PAYEE:
ASAHI KASEI PHARMA CORPORATION
4
PURCHASE ORDERS; SHIPMENTS TO PURCHASER.
4.1 TERMS OF
DELIVERY.
All
deliveries of Planova under this Agreement shall be made by Asahi
to
Purchaser by air on the basis of FCA Japan Airport as selected by
Asahi, but
with the air carrier to be selected by Purchaser (or by Asahi, if
Purchaser
fails to make a timely designation of the carrier), as the term
"FCA" is defined
in INCOTERMS/2000 and with the parties' respective obligations
being determined
in accordance with INCOTERMS/2000 unless otherwise specifically
provided for in
his Agreement.
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FORM: JANUARY 2004
4.2 PRICE
BASIS.
All prices
for Planova set forth in Asahi's notices under Section 3.1
shall be on the same basis as specified in Section 4.1. Without
limiting the
generality of the foregoing, all such prices shall be the net a
Mounts
receivable by Asahi, and do not include (and Purchaser shall be
liable for and
shall pay) any and all costs and expenses incurred subsequent to
transfer of
title as provided for in Section 4.3 (including any insurance or
freight costs),
any taxes, duties or other charges of any type to be incurred in or
[ILLEGIBLE]
route to the shipping destination or otherwise relating to
importation into the
shipping destination (whether or not contemplated to be applicable
as of the
date of this Agreement, and regardless of when imposed or
assessed).
4.3 DELIVERY
DATE; TRANSFER OF TITLE AND RISK.
Title to
and all risk of loss of or damage to any Planova shall pass to
Purchaser at the Time specified for "transfer of risks" under the
applicable
"FCA" term defined in INCOTERMS/2000, and the date on which the
foregoing occurs
shall be the delivery date for those Planova for purposes of this
Agreement.
4.4 PURCHASE
ORDERS.
Sales of
Planova by Asahi to Purchaser shall be made by means of
purchase
orders delivered in writing or sent by facsimile by Purchaser to
Asahi
("PURCHASE ORDER"), provided that no Purchase Order shall be
binding upon Asahi
until and unless Asahi dispatches the acceptance letter by tax to
Purchaser
within five (5) working days after the receipt of the Purchase
Order, provided
further that any terms and conditions contained in any purchase
order shall be
superseded in their entirety by this Agreement.
4.5 SHIPMENT TO
PURCHASER.
Asahi
shall ship Pianova specified in each Purchase Order accepted by
Asahi within four (4) weeks after the date of Asahi's acceptance of
that
Purchase Order or by any such later date as may be agreed on
between the
parties. Asahi shall provide for all shipments a packing list and
invoice which
will contain at least the following information: (i) Purchase Order
number (ii)
Name of relevant Planova product (iii) Planova quantity transported
and (iv)
Shipping Date from plant.
4.6
STERILIZATION OF FILTERS.
Asahi
shall sterilize [ILLEGIBLE] Planova Filters prior to delivery
to
Purchaser.
4.7
SPECIFICATION CHANGES.
4.7.1
Asahi shall notify Purchaser in writing of any proposed changes
in
basic
specifications of Planova a Filters described in Schedule 1
which
may affect
performance of Planova Filters ("SPECIFICATION CHANGE") no
later than
six (6) months prior to the implementation by Asahi.
4.7.2
Should Purchaser deem that new regulatory approval is required
in
connection
with the Specification Change, Purchaser shall give Asahi a
notice to
such effect with
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FORM: JANUARY 2004
appropriate and adequate documentation within two (2) months after
receipt
of Asahi's
notice of Specification Change, and both parties shall promptly
consult
with each other possible measures to be taken including
amendments
to the
Specification Change proposed by Asahi, in order to avoid an
application for the new regulatory approval. If the parties fail to
reach
mutually
acceptable measures on or before the proposed implementation
date
of the
Specification Change, Asahi shall continue to supply Planova
Filters
without the Specification Change for such period not exceeding
three (3)
years from said proposed implementation date as required by
Purchaser.
5. USE OF
PLANOVA, ETC.; PURCHASER'S RISK AND LIABILITY.
5.1 VISUAL
INSPECTION.
Purchaser
agrees to carry out a visual inspection of all Planova in each
delivery immediately after such delivery to Purchaser's premises in
accordance
with Asahi's "Instruction for Use" as provided from time to time
and will not
use any Planova that Purchaser observes to have such defects as
described in the
instruction.
5.2 USE AFTER
EXPIRATION DATE.
Purchaser
agrees not o use any Planova for any purpose after the
expiration date of Planova to be indicated by Asahi.
5.3 NO RE-USE OR
OTHER IMPROPER USE.
Purchaser
agrees not to re-use Planova in any manner and further agrees
to
use Planova solely for its intended purposes in the manufacture of
Purchaser's
Products as defined in Section 1.5 and in accordance with Asahi's
"Instruction
for Use," "Standard Operation Procedure of Integrity Test,'
"Filtration
Procedure" and other Asahi's written instructions as provided from
time to time.
5.4 HANDLING,
TRANSPORT AND STORAGE.
In order
to maintain the quality of Planova, Purchaser agrees to observe
the instructions indicated in Asahi's "Instruction for Use" as
provided from
time to time in handling, transporting and storing Planova.
5.5 PRE-USE
& POST-USE INTEGRITY TESTS.
Purchaser
shall conduct all pre-use and post-use integrity tests in
accordance with Asahi's "Standard Operation Procedure of Integrity
Test" as
provided from time to time by Asahi (or such an integrity tests as
may be
developed by Purchaser and accepted by Asahi as a substitute for
the integrity
tests as stipulated above) as well as performance tests which may
be required
from time to time under Purchaser's internal procedures or under
applicable laws
and regulations, prior to making use and immediately after the use
of any
Planova Filters. Purchaser agrees that it shall not use any Planova
Filters
which do not successfully pass such
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FORM: JANUARY 2004
pre-use integrity tests and that the results of the post-use
integrity tests
shall be retained by Purchaser for a sufficient period required by
laws and
regulations applicable to Purchaser.
5.6 NATURE OF
THE INTEGRITY TESTS.
It
understood by the parties hereto that the integrity tests in
accordance
with Asahi's Standard Operation Procedure of Integrity Test" are
based on data
under specified conditions. Therefore, Asahi will not guarantee
than any of
Planova Filters has a viral reduction performance for any specific
rate under
any conditions even if it has passed the integrity tests.It is
further
understood that the viral reduction performance of the Purchaser's
filtration
Process which incorporates any of Planova Filters under specified
conditions
should be determined in a validation of said process to be
conducted by the
Purchaser.
5.7 PURCHASER'S
RISK AND LIABILITY.
Purchaser
agrees that my failure on its part to fully comply with the
undertakings of Sections 5.1, 5.2, 5.3, 5.4 and 5.5 shall be at
Purchaser's sole
risk and liability.
6.
WARRANTY; LIMITATION ON LIABILITY.
6.1 LIMITED
WARRANTY.
6.1.1
Purchaser acknowledges that Asahi has no control over the
processes
followed
by Purchaser either with respect to Purchaser's use of Planova
or
with
respect to any element concerning Purchaser's manufacture or
handling
of
Purchaser's Products. Asahi warrants to Purchaser, [but not to
any
subsequent
purchaser of any Planova from Purchaser or to any other person
or
entity], that:
6.1.1.1
each Planova Filter delivered to Purchaser under this
Agreement,
will be manufactured in accordance with the specifications set
forth
in Schedule 1 attached hereto, will be inspected in accordance
with
the Quality Control Standards set forth in Schedule 2 and will
be
effectively sterilized.
6.1.1.2
Planova Related Products will be manufactured in strict
compliance
with with the written specifications to be provided from time
to
time by Asahi and will be inspected in accordance with Asahi's
quality control standard inspection procedures.
6.1.2
ASAHI [ILLEGIBLE] NO REPRESENTATIONS OR WARRANTIES OF ANY KIND
OTHER
THAN AS
SPECIFICALLY SET FORTH IN SECTION 6.1.1 AND DISCLAIMS ANY AND
ALL
IMPLIED
WARRANTIES OF ANY KIND, INCLUDING THOSE OF MERCHANTABILITY OR
FITNESS
FOR A PARTICULAR PURPOSE OR OTHERWISE, AND OF ANY OTHER
OBLIGATION
OR
LIABILITY OF ASAHI, INCLUDING ANY OBLIGATION
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FORM: JANUARY 2004
OR
LIABILITY BASED ON ANY CLAIM OF NEGLIGENCE, STRICT LIABILITY OR
OTHERWISE,
OR ANY CLAIM THAT PURCHASER'S USE OF PLANOVA INFRINGES ANY
PATENT OR
OTHER INTELLECTUAL PROPERTY RIGHTS OF ANY THIRD PARTY.
6.2 CLAIM
PROCEDURES AND EXCLUSIONS.
No
brea
