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Certain confidential portions of this Exhibit were omitted by means of
blackout of the text (the "Xxxx"). This Exhibit has been filed separately with
the Secretary of the Commission without the Xxxx pursuant to the Company's
Application Requesting Confidential Treatment under Rule 406 under the
Securities Act.
EXHIBIT 10.4
EXCLUSIVE SUPPLY AGREEMENT
THIS AGREEMENT (the "Agreement") is entered into as of the 1st day of
June, 1991,
BY AND BETWEEN:
1. ANTHRA PHARMACEUTICALS Inc., a company incorporated and organized under
the laws of the State of Delaware, U.S.A., having a place of business at 00,
Xxxxxx Xxxx, Xxxxxxxxx, XX 00000, X.X.X. ("ANTHRA"),
AND,
2. OMNICHEM S.A., a company incorporated and organized under the laws of
Belgium, having a place of business at the Industrial Research Park, 1348
Louvain-la-Neuve, Belgium ("OMNICHEM").
WITNESSETH:
WHEREAS, ANTHRA has acquired, via exclusive licence agreements entered
into with DANA-FABER CANCER INSTITUTE, Boston, Massachusetts, the exclusive
rights to the hereafter defined AD32 and other anthracycline products, and has
as a result sufficient right in and to said products to enable it to enter into
this Agreement and to grant OMNICHEM the hereincontained rights;
WHEREAS, OMNICHEM has, on the basis of the technological files supplied by
ANTHRA, developed a technology enabling the conversion of daunorubicin into AD32
in substantially more efficient proportions, which could allow the profitable
marketing of the AD32;
WHEREAS, ANTHRA is willing to complete the clinical development and
marketing of AD32 in the U.S. market and subsequently in other markets, and will
thereto need a long term source of AD32 as produced by OMNICHEM.
WHEREAS, OMNICHEM is desirous to manufacture the AD32 and other
anthracycline products to which ANTHRA has exclusive rights;
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NOW, THEREFORE, in consideration of the premises and mutual covenants
herein contained, the parties hereto have agreed the following:
Article 1: Exclusive Production and Supply
1.1. For the purpose of this Agreement, "the AD32" shall mean the daunorubicin
derivate for which ANTHRA has an exclusive licence, and regarding which
OMNICHEM has developed a more efficient conversion process
1.2. During the term of this Agreement, ANTHRA grants to OMNICHEM, which
accepts, the worldwide exclusive right to manufacture only for ANTHRA the
AD32 bulk substance using daunorubicin delivered by ANTHRA or any of its
sublicencees.
1.3. ANTHRA shall not manufacture the AD32 or have the AD32 manufactured by
suppliers other than OMNICHEM prior to the termination of this Agreement
pursuant to Article 5. ANTHRA shall pass this obligation on to, and see to
the acceptance thereof by, all its sublicencees and other contractors
which would acquire rights to the AD32 during the term of this Agreement
as specified in Article 5.
1.4. ***
1.5. All payments pursuant to a delivery of AD32 shall be due within 30 days of
the date of the invoice, which shall be established and sent to ANTHRA
upon shipment.
1.6. All payments shall be made in Belgian francs on the Belgian bank account
communicated by OMNICHEM to ANTHRA from time to time, net from any banking
commission or fee.
1.7. Unless otherwise agreed between the parties, delivery shall be made within
sixty (60) days to the port of arrival in the U.S.A. and risk shall pass
at the port of departure. OMNICHEM shall obtain all necessary licences and
permits required for the delivery of the product. OMNICHEM shall deliver
the product to ANTHRA in accordance with ANTHRA's reasonable written
instructions. OMNICHEM shall bear the cost of shipment to ANTHRA.
Article 2: Registration
OMNICHEM shall submit to ANTHRA before July 15th a draft Drug Master file
which is necessary for the registration by ANTHRA of the AD32. The Drug Master
File shall be submitted by Anthra to the Food and Drug Administration. ANTHRA
will refund to OMNICHEM the costs incurred in the preparation and drawing up of
the Drug Master File, which costs are currently estimated at ***. OMNICHEM
agrees to prepare the necessary annual reports to the Drug Master File to keep
it up to date. OMNICHEM agrees not to make any change to the manufacturing
process for AD32 which would
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necessitate an amendment to the Drug Master File without the prior written
consent of ANTHRA.
Article 3: Other Agreements
3.1. In respect of Contract Products other than the AD32, ANTHRA, prior to
negotiating the development and production of such products with third
parties, shall consult and negotiate in good faith with OMNICHEM the
possible conditions under which OMNICHEM could undertake this development,
production and supply.
Article 4: Quality Control
4.1. OMNICHEM warrants that all shipments of AD32 will meet the specifications
listed in Attachment A, shall be manufactured in accordance with current
good manufacturing practices as defined by the U.S. Food and Drug
Administration and shall not contain any product or article which is
adulterated or misbranded as these terms are defined in the U.S. Food,
Drug, and Cosmetic Act or in similar laws enacted by the states. OMNICHEM
will supply to ANTHRA a certificate of analysis for each lot of AD32
supplied pursuant to this Agreement evidencing that the lot of AD32 meets
the specifications listed in Attachment A. Following receipt of each
shipment of AD32, ANTHRA shall be entitled to inspect the AD32 and to
perform, at its own costs, such quality control checks as it deems
necessary to confirm that the product is free from defects and complies
with the specifications listed in Attachment A. In the event that any
delivery of AD32 contains defects or does not comply with the
specifications, ANTHRA shall inform OMNICHEM of such non-conformity in
writing, within one months after receipt of the shipment, specifying the
non-complying characteristics of the AD32.
4.2. Upon receipt of such notice, OMNICHEM shall replace at its own costs the
AD32 which does not comply with the quality control specifications or, at
the election of ANTHRA, refund its money. OMNICHEM shall make every
reasonable effort to perform such replacement within 60 days after having
received such notice. ANTHRA shall have the right to inspect OMNICHEM's
manufacturing facilities and any documents held by OMNICHEM relating to
the manufacture of AD32 upon reasonable written notice to OMNICHEM. ANTHRA
shall also have the option to be present during any inspection of
OMNICHEM's manufacturing facility by officials of the U.S. Food and Drug
Administration, and shall receive copies of any FDA documents, letters or
forms received by OMNICHEM relating to its manufacturing of AD32.
4.3. OMNICHEM agrees to pay any damages incurred by Anthra and flowing directly
from the failure of the product to meet specifications. ANTRHA agrees to
bear the risks that may be incurred through use of the product as a
therapeutic agent.
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Article 5: Duration and Termination
5.1. This Agreement shall be binding and remain in force:
5.1.1. for the period starting on the signing of this Agreement and ending
on the date of expiration of the validity of the U.S. Patent No. 4,035,566
covering the AD32.
5.2. Each party shall however have the right to forthwith terminate this
Agreement by written notice at any given time if:
5.2.1. the other party fails to observe any of the terms hereof to a
material and significant extent, provided the non-defaulting party
provides the defaulting party with sixty (60) days notice of
termination, within which time the default or breach may be cured;
5.2.2. the other party becomes insolvent, or has a receiver appointed, or
execution or distress levied upon its assets;
5.2.3. as a result of an order of government or any other official
authority, the continued operation of this Agreement in all of its
provisions is prevented or delayed for an unspecified and indeterminate
period.
5.3. ANTHRA shall have the right to terminate this Agreement if, for any
reason, OMNICHEM can no longer continue to manufacture AD32.
5.4. If ANTHRA terminates this Agreement pursuant to Article 5.3, OMNICHEM
shall no longer have any licence, exclusive or otherwise, to manufacture
AD32 for ANTHRA. The exclusive licence shall revert back to ANTHRA without
charge. Along with the requisite technical information to enable Anthra to
manufacture AD32, OMNICHEM shall also provide ANTHRA with all prior
manufacturing documentation to support prior shipments of AD32 to Anthra.
Article 6: Right of Last Refusal after termination
6.1 After termination of this Agreement as per Article 5, ANTHRA shall be
entitled to have the manufacture of any and all AD32 undertaken by any
party of its choice.
6.2. However, ANTHRA grants OMNICHEM, which accepts, a right of last refusal to
further manufacture the AD32 at conditions equal in all respects,
including price, to those offered by a third party supplier.
This right of last refusal shall remain in force for a period of ten (10) years
after termination of this Agreement. It shall however not apply if this
Agreement is terminated by ANTHRA, in due application of subarticle 5.2.
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Article 7: Disclosure of Information
7.1. Anything in this Agreement to the contrary notwithstanding, the parties
shall hold in confidence, during the performance of this Agreement and for
a period of ten (10) years thereafter, any knowledge, know-how, practices,
process or other information pertaining to AD32, hereinafter referred to
as "Information", disclosed by the other party, and shall not disclose,
during the said period, that Information to any third party, including to
its own sublicencees and contractors without first obtaining the written
consent of the disclosing party, except as may be otherwise provided
herein, or as may be required for purposes of investigating, manufacturing
and marketing AD32 or for securing essential or desirable authorizations,
privileges, or rights from governmental agencies, or as required to be
disclosed to a governmental agency or as necessary to file or prosecute
patent applications or to carry out any litigation concerning AD32.
7.2. The party's duty of confidentiality shall not extend to:
- any Information that, at this time of disclosure, is in or later
becomes part of the public domain;
- any Information that is published after disclosure, unless
publication is a breach by any party of this clause;
- any Information that, prior to disclosure by the disclosing party,
was already in the possession of the recipient party in the ordinary
course of its business, or as evidenced by proof of actual prior use
by the recipient party;
- any Information which obtained by the recipient party from a third
party, who is lawfully in possession of such Information, is not in
violation of any contractual, legal or fiduciary obligation to the
disclosing party with respect to that Information, and does not
prohibit the recipient from disclosing such Information to others.
7.3. During the performance of this Agreement and for a period of ten (10)
years thereafter, the parties shall use any Information disclosed by the
other party solely for the purposes contemplated by this Agreement. No
party shall use or exploit the Information in any other way.
7.4. Any trademarks or designs created by either ANTHRA or OMNICHEM shall be
used by each party as the party owning the trademark may reasonably
require. The parties shall immediately bring to each other's attention any
improper or wrongful use of any trademark or other intellectual property
and take all steps necessary to defend the rights and interest in all
trademarks and intellectual property.
7.5. Any inventions, findings, discoveries, additions, modifications,
formulations, changes or proprietary information jointly conceived,
created or developed by the
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parties relating to AD32 hereto shall belong jointly to the parties unless
otherwise agreed.
Article 8: Late Payments
All sums due by one of the parties to this Agreement to the other pursuant
to any provision of this Agreement, shall bear, from the due date to the day of
effective crediting of the creditor's account for the proper amount, an interest
computed for each started month of delay at an annual rate of 2 points above the
average one-year term LIBOR rate for BEF applying on the first day of such
month.
Article 9: Force Majeure
Notwithstanding anything to the contrary herein contained, if the
performance of this Agreement by any party, or any obligation of any party
hereunder is temporarily prevented, restricted or interfered with by reason of
any event beyond the reasonable control of a party hereto, then the party so
affected shall promptly notify the other party of all reasonable resulting
difficulties. Events beyond the reasonable control of a party hereto shall
include strikes, lockouts, labor disputes, riots, fires, explosions, and damages
due to natural forces. Upon such notice, the disabled party shall, for the
duration of its disability, be excused from the performance of such of its
obligations as are prevented, restricted, or of such of its obligations as are
prevented, restricted, or interfered with by reason of the occurrence of any of
the events above enumerated and such party shall not be deemed to be in default
under this Agreement nor be subject to any liability or damage provided that the
affected party shall use its best efforts to avoid or remove such causes of
non-performance and shall continue performance with the utmost dispatch whenever
such causes are removed. The time period within which any party is to perform
such obligation under this Agreement shall be extended by the period of such
disability. When any such circumstances arrive, the parties shall discuss what,
if any, modification of the terms of this Agreement may be required in order to
arrive at any equitable solution.
Article 10: Severability
If any term or provision of this Agreement is held to be illegal or
unenforceable, then this Agreement, except for such part or parts thereof, shall
continue to be in full force and effect. The parties shall in good faith seek to
supersede the unenforceable or invalid clause with an enforceable and valid one
providing to the largest possible extent the same financial and commercial
effect on the parties.
Article 11: Governing law and competent jurisdiction
11.1. The present Agreement shall be governed by Belgian law.
11.2. All disputes arising out of the validity, construction or performance of
the present Agreement shall be settled by arbitration under the Rules of
the American Arbitration Association.
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11.2.1. The arbitral tribunal shall consist of three arbitrators. One
arbitrator shall be appointed by ANTHRA and one shall be appointed
by OMNICHEM; these two arbitrators shall jointly select the third
arbitrator. If the arbitrators cannot agree on the designation of
a third arbitrator, or if one party fails to designate an
arbitrator, the authority provided by the Rules of the American
Arbitration Association shall make the appointment.
11.2.2. The seat of arbitration shall be London, England.
11.2.3. The arbitration shall be held in the English language.
11.2.4. For enforcement of this Agreement or an arbitration award or in
aid of arbitration, the parties consent to the jurisdiction of the
courts of Brussels, Belgium, and New Jersey, U.S.A.
Article 12: Miscellaneous
12.1. The provisions of this Agreement shall not be modified other than by a
written agreement signed by the parties. This Agreement constitutes the
entire Agreement of the parties and supercedes all existing agreements.
12.2. This Agreement may not be assigned by OMNICHEM without the prior consent
of ANTHRA which consent shall not be unreasonably withheld.
12.3. Any notice required or permitted under this Agreement shall be sent by a
certified air mail, postage prepaid, international cable, facsimile
transmission or telex (notice by cable, facsimile or telex must also be
confirmed by a certified, air mail copy, postage prepaid) to the following
addresses of the parties:
to ANTHRA:
Anthra Pharmaceuticals, Inc.
00 Xxxxxx Xxxx
Xxxxxxxxx, Xxx Xxxxxx 00000
Fax: 000-000-0000
to OMNICHEM:
Omnichem S.A.
Industrial Research Park
1348 Louvain-la-Neuve
Belgium
Fax: ________________________
IN WITNESS WHEREOF, the parties have caused this Agreement to be executed in
duplicate by their duly qualified officers or representatives.
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Done in /s/ Xxxxxxx X. Xxxxxx on 28 June, 1991, FOR AND ON BEHALF OF ANTHRA
PHARMACEUTICALS Inc.
Done in /s/ X. xx Xxxxx xx Xxxxxx on 22nd July, 1991, FOR AND ON BEHALF OF
OMNICHEM S.A.
B. xx Xxxxx xx Xxxxxx
Manager Marketing & Business Operations
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