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Exhibit 10.11
SUPPLY AGREEMENT
This Agreement made and entered into this 24th day of August, 1999
by and among
DAIICHI PHARMACEUTICAL CO., LTD, a company organised and existing
under the laws
of Japan having its registered office at 14-10 Nihonbashi 3-chome,
Chuo-ku,
Tokyo, Japan (hereinafter called DAICHI) and OMRIX
BIOPHARMACEUTICALS SA., a
company organised and existing under the laws of Belgium having its
registered
office at 140 Avenue Loise, B2, B-1050 Brussels, Belgium
(hereinafter called
OMRIX).
WHEREAS, OMRIX has developed a TWO COMPONENT FIBRIN GLUE for human
use
(hereinafter called PRODUCT), comprising a component "A" which
comprises a
cryoprecipitate of whole blood and a sufficient amount of
Tranexamic Acid
4-(aminomethyl) cyclohexane carboxylic acid (hereinafter called
COMPOUND) or its
pharmaceutically acceptable salts and, a component "B" comprising a
proteolytic
enzyme being capable of cleaving specifically fibrinogen present in
component
"A" and causing the formation of fibrine polymer, and
WHEREAS, OMRIX has applied the patent of the PRODUCT on October
13th, 1994 for
International Patent Classification A61L 25/00, C12N 5/00,
International
Publication Number WO 94/22503, and
WHEREAS, OMRIX wishes to stably purchase the compound manufactured
by DAIICHI,
which is necessary for manufacturing the PRODUCT, and
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WHEREAS, DAIICHI is willing to accept such wish and designate
DAIICHI
PHARMACEUTICAL EUROPE GMBH, DAIICHI's wholly owned subsidiary, a
company
organised and existing under the laws of Germany having its
registered office at
Immermannstr 50-52, 40210 Dusseldorf, Germany (hereinafter called
DPE) as a
supplier of the COMPOUND and OMRIX is willing to accept such
designation, and
WHEREAS, OMRIX intends to contract with OMRIX ISRAEL LTD., OMRIX's
wholly owned
subsidiary, a company organised and existing under the laws of
Israel having its
registered office at Bldg. 14 Kiryat Weizmann, Nes Ziona P.O. Box
619 Rehovot
76106, Israel (hereinafter called OIL), for the manufacturing the
PRODUCT for
OMRIX.
NOW, THEREFORE, in consideration of the undertakings of the parties
herein
contained, it is hereby agreed as follows:
ARTICLE 1: SUPPLY AND PURCHASE
1.1 DAIICHI hereby
shall admit OIL as a contract manufacturer of the PRODUCT
for
OMRIX, and OMRIX shall make OIL observe the articles and the
provisions of this Agreement. In case OMRIX shall designate any
third party
other than OIL as a contract manufacturer of the product, OMRIX
shall
inform DAIICHI through DPE of the name of that company in
advance.
1.2 In accordance with
the following terms and conditions, DAIICHI shall supply
to
OMRIX through DPE all OMRIX's requirements of the COMPOUND and
OMRIX
shall purchase the COMPOUND from DAIICHI through DPE for
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manufacturing the PRODUCT by OIL and selling the PRODUCT. All
COMPOUND
supplied to OMRIX by DAIICHI through DPE hereunder shall be
delivered to
OIL
directly. It is hereby understood that OMRIX shall neither export
the
COMPOUND to any third party nor use the COMPOUND for manufacturing
other
products except the PRODUCT without the prior written consent of
DAIICHI
through DPE, which consent shall not be unreasonably withheld.
1.3 Purchase Order
OMRIX shall place firm orders to DAIICHI through DPE for
OMRlX's
requirements of the COMPOUND not later than ninety (90) days before
the
expected date of shipment. DAIICHI shall notify OMRIX through DPE
of its
receipt and DAIICHI shall inform OMRIX through DPE of the date of
shipment
in
advance. In the event that DAIICHI through DPE notify OMRIX that
DAIICHI
cannot fulfil such orders, the parties hereto shall negotiate in
good
faith. All orders by OMRIX shall be made on a multiple of fifty
(50)
kilogram.
1.4 Estimate of
Purchase
OMRIX shall notify DAIICHI through DPE every year during the term
of this
Agreement, not later than ninety (90) days prior to the beginning
of each
calendar year, of OMRIX monthly purchase estimation of the COMPOUND
for the
next
full calendar year.
ARTICLE 2: PRICE AND PAYMENT
DAIICHI and OMRIX shall negotiate the price and the payment term of
the COMPOUND
in separate of this Agreement
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ARTICLE 3: SPECIFICATIONS AND CLAIMS FOR DEFECTS
3.1 The COMPOUND
supplied hereunder shall meet the specifications attached in
Annex A. It is hereby understood that the COMPOUND shall meet
the
specifications of Tranexamic Acid monograph in European
Pharmacopeia.
Whenever the specifications of Tranexamic Acid monograph shall be
changed,
the
specifications of the COMPOUND shall be changed accordingly.
3.2 DPE shall attach a
certificate of analysis executed by DAIICHI to the
respective documents for each shipment of the COMPOUND.
3.3 Promptly after OIL
receives each shipment of the COMPOUND, OMRIX shall have
OIL
carry out the inspection and testing. The COMPOUND shall be
considered
to
comply with the specifications, if OIL through OMRIX, does not
notify
DAIICHI through DPE of any objections within ninety (90) days after
receipt
of
such Shipment.
3.4 In the event that
OIL through OMRIX, notifies DAIICHI through DPE within
ninety (90) days after receipt of shipment of the COMPOUND that
such
COMPOUND does not comply with the specifications and presents to
DAIICHI
through DPE an evidence for any defect, DAIICHI through DPE shall
either
replace the defective COMPOUND free of charge or credit the
invoiced amount
for
such detective COMPOUND to OMRIX, and DAIICHI and DPE
(hereinafter
collectively called DAIICHI GROUP) shall not bear any other
liability It is
understood, however, that OIL, on behalf of OMRIX shall not return
to
DAIICHI through DPE any defective shipment of the COMPOUND without
the
prior consent of DAIICHI through DPE.
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ARTICLE 4: REPORT
4.1 OMRIX shall submit
DAIICHI through DPE its quarterly reports on the use of
the
COMPOUND for the PRODUCT on monthly basis within thirty (30) days
after
the
end of such calendar quarter.
4.2 OMRIX shall inform
DAIICHI through DPE of its stock quantity of the
COMPOUND on the last day of each quarter within thirty (30) days
after the
end
of such calendar quarter.
ARTICLE 5: EXCHANGE OF INFORMATION
5.1 DAIICHI GROUP and
OMRIX shall furnish each other on regular basis with
information and data relating to the PRODUCT and/or the COMPOUND
which
either party considers
useful to the other party, such as clinical
application and sales promotion, to be obtained
