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 00-00 Xxxxxxxxxx 0-xxxxx, Xxxx-xx,
Xxxxx, Xxxxx (hereinafter called DAICHI) and OMRIX BIOPHARMACEUTICALS SA., a
company organised and existing under the laws of Belgium having its registered
office at 000 Xxxxxx Xxxxx, X0, X-0000 Xxxxxxxx, Xxxxxxx (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
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
Xxxxxxxxxxxx 00-00, 00000 Xxxxxxxxxx, Xxxxxxx (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 Xxxx. 00 Kiryat Weizmann, Nes Ziona X.X. Xxx 000 Xxxxxxx
00000, Xxxxxx (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
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
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.
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 by either party during the
terms hereof. Either DAIICHI GROUP or OMRIX has the right to use and to
have used such information and data free of charge.
5.2 OMRIX shall provide DAIICHI through DPE with two packages of the PRODUCT
and insert-sheet before its launch. Whenever any substantial changes in the
PRODUCT and/or the insert sheet of the PRODUCT provided to DAIICHI shall be
made, OMRIX shall inform DAIICHI through DPE of with two packages of the
PRODUCT including insert-sheets as free of charge as soon as possible.
5.3 DAIICHI through DPE shall promptly provide to OMRIX, by the CIOMS form
(COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES), with
necessary information and data relating to serious side effects and/or
serious adverse events, associated with the use of the finished preparation
for human use containing the COMPOUND as the active ingredient, if reported
to DAIICHI from any sources.
5.4 OMRIX shall promptly provide to DAIICHI through DPE. by the CIOMS form
(COUNCIL FOR INTERNATIONAL ORGANIZATIONS OF MEDICAL SCIENCES), with
necessary information and data relating to serious side effects and/or
serious adverse events, associated with the use of the PRODUCT, if reported
to OMRIX from any sources.
The terms "Serious" provided for in the paragraph 5.3 and 5.4 above have the
following meaning:
- result in death
- life-threatening
- inpatient hospitalisation or prolongation of existing
hospitalisation
- result in persistent or significant disability/incapacity
- congenital anomaly/birth defect
- other medically important condition
5.5 Promptly after the execution of this agreement and from time to time during
the term of this agreement, DAIICHI through DPE shall provide OMRIX with
the current valid Certificate of Suitability of the COMPOUND.
ARTICLE 6.: SALES AND PROMOTION
6.1 OMRIX shall sell and promote the PRODUCT in its own responsibility and
expenses.
6.2 OMRIX shall 'notify DAIICHI through DPE the names of the distributors in
each country where the PRODUCT is marketed.
6.3 OMRIX shall use its own trademark "QUIXIL" as the tradename of the PRODUCT
in Israel and Mexico. OMRIX shall inform the tradename of the PRODUCT of
each country to DAIICHI through DPE before its launch.
ARTICLE 7.: SECRECY
7.1 Each party (hereinafter called the RECEIVING PARTY) shall keep strictly
secret and confidential the information and data received from the other
party (hereinafter called the DISCLOSING PARTY) under this Agreement
except:
a) information and data which at the time of disclosure by the DISCLOSING
PARTY are in the public domain
b) information and data which after disclosure by the DISCLOSING PARTY
enter the public domain through no improper conduct of the RECEIVING
PARTY;
c) information and data which prior disclosure by the DISCLOSING PARTY
were already in the possession of the RECEIVING PARTY as evidenced by
the RECEIVING PARTY'S written records;
d) information and data which subsequent to disclosure hereunder are
obtained by the RECEIVING PARTY from third parties, who are lawfully
in possession of such information and data who do not require
RECEIVING PARTY to refrain from disclosing such information and data
to others.
7.2 The provisions of the paragraph 7.1 hereof shall not apply to the extent
that it may be necessary to disclose, on the confidential basis, said
information and data to OIL, the RECEIVING PARTY'S outside experts for the
purpose of this Agreement.
ARTICLE 8.: HOLD HARMLESS
OMRIX shall assume and hold DAIICHI GROUP harmless from any responsibility and
liability for any damages, either direct or indirect, or consequential damages,
sustained or alleged to have been sustained, by any person or persons in
connection with the COMPOUND or PRODUCT, unless such damages are the result of
DAIICHI GROUP'S negligence.
ARTICLE 9.: DURATION AND TERMINATION
9.1 This Agreement shall continue in full force and effect for a period of five
(5) years from the date of execution of this Agreement and shall be
automatically renewed for subsequent two (2) years period each unless not
less than 6 months before the expiration of the term of this Agreement
either party shall notify the other party of its desire to terminate this
Agreement.
9.2 Upon any breach, default or other defect of performance by either party
under this Agreement the other party may terminate this Agreement by ninety
(90) days written notice. The said notice shall become effective at the end
of the said ninety (90) day period unless the party in breach shall remedy
such breach, default or other defect or performance during the said ninety
day period.
ARTICLE 10.: FORCE MAJEURE
Neither party shall be responsible for a failure or a delay in performance of
any of its obligations under this Agreement due to force majeure such as, but
not limited to, governmental orders of restrictions, war, fire, flood,
earthquake, embargo, accident, explosion, strike, lockout or other labour
disputes or any other cause beyond the control
of the parties concerned. The parties shall use due diligence to remove any such
causes and to resume performance as soon as it is reasonably feasible.
ARTICLE 11.: APPLICABLE LAW
This Agreement and any additional agreement to be executed in connection
therewith between the parties hereto shall be prepared in English language. This
Agreement and the said additional agreement shall be governed by and construed
in accordance with the laws of United Kingdom.
ARTICLE 12.: ARBITRATION
All disputes, controversies, or differences which may arise between the parties
hereto, out of or in relation to or in connection with this Agreement, or for
the breach thereof, shall be settled by arbitration. If the arbitration is
initiated by DAIICHI, it shall be held in Brussels, Belgium in accordance with
the rules of the International Chamber of Commerce. If the arbitration is
initiated by OMRIX, it shall be held in Tokyo, Japan in accordance with the
rules of the Japan Commercial Arbitration Association. The award shall be final
and binding upon the parties hereto.
ARTICLE 13.: NOTICE
13.1 Any notice given by one party hereto to the other hereunder shall be made
by registered air mail, provided, however, that as for an urgent matter
facsimile or telex may be used, in which case the issuing party shall give
the notice to the receiving party to confirm the contents promptly.
13.2 The notice under the preceding paragraph, unless otherwise provided, shall
be deemed to be effective upon its receipt by the receiving party. The said
notice shall be given to the address of the receiving party first above
written unless or until the address is changed by notice.
ARTICLE 14.: NON-WAIVER
No omission or delay of either party hereto in requiring due and punctual
fulfilment by other party of the obligations of such other party hereunder shall
be deemed to constitute a waiver by such party of its right to require such due
and punctual fulfilment or of any of its remedies hereunder.
ARTICLE 15.: MISCELLANOUS
15.1 If one or more provisions of this Agreement shall to any extent be invalid
or unenforceable under any applicable law, the remainder of this Agreement
shall not be not be affected thereby and shall be valid and enforceable to
the fullest extent permitted by applicable law. The parties shall cooperate
in amending this Agreement in order to replace the invalid provision(s) by
valid provision(s) having economic effects as close as possible to the
invalid one(s).
15.2 The captions of Article in this Agreement are for convenience only, and
this Agreement shall not be constructed or interpreted by reference to such
captions.
15.3 This Agreement constitutes the entire Agreement between the parties hereto
concerning the subject matter hereof and any representation, promise or
condition not incorporated in this Agreement, shall not be binding upon
either party.
15.4 Independent Contractors. The relationship of the parties hereto is that of
independent contractors. The parties hereto are not deemed to be agents,
partners or joint ventures of the others for any purpose as a result of
this Agreement or the transactions contemplated thereby.
15.5 This Agreement shall not be assignable by either party to any third party
hereto without the written consent of the parties hereto.
IN WITNESS WHEREOF the parties hereto have caused this Agreement to be executed
by their duly authorised officers upon the date first above written in duplicate
original, one (1) original to be retained by DAIICHI and OMRIX.
DAIICHI PHARMACEUTICAL CO., LTD.
/s/ X. Xxxxx
-------------------------------------
Date Aug 24, 1999
OMRIX BIOPHARMACEUTICALS SA
/s/ Xxxxxx Xxxx
-------------------------------------
Date Sept 02, 1999
Accepted & Attested by:
DAIICHI PHARMACEUTICAL EUROPE GMBH
/s/ Xxxxxxxx Xxxxxxxx
-------------------------------------
Date Aug 26, 1999
ANNEX A
SPECIFICATIONS AND TEST METHODS OF TRANEXAMIC ACID
TESTS LIMITS METHODS
----- ------ -------
APPEARANCE A white crystalline powder Visual Inspection
IDENTIFICATION Spectrum, confirms to reference Ph-Eur<875>
spectrum
PH (5% W/W SOLUTION) 6.5-8.0 Ph-Eur<875>
CLARITY AND COLOUR OF Clear and colourless JP X III
SOLUTION
RELATED SUBSTANCES Max 1.0% Ph-Eur<875>
CIS-AMC Max 0.5% Ph-Eur<875>
BROMIDES Max 670 ppm Ph-Eur<875>
HEAVY METALS Max 20ppm Ph-Eur<875>
LOSS ON DRYING Max 0.5% w/w Ph-Eur<875>
SULPHATED ASH Max 0.1% w/w Ph-Eur<875>
ASSAY TRANEXAMIC ACID 99 0-101.0% Ph-Eur<875>
PYROGEN TEST (--) JP X III
