EXHIBIT 10.11
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[CERTAIN INFORMATION HAS BEEN OMITTED HEREIN PURSUANT TO A REQUEST FOR
CONFIDENTIAL TREATMENT UNDER RULE 24b-2. THE REDACTED MATERIAL HAS BEEN
SEPARATELY FILED WITH THE COMMISSION.]
LICENSE AGREEMENT
-----------------
between
ALCO Chemicals Ltd., 000 Xxxxxxx Xxxxxx, Xxxxxx XxX 0XX, Xxxxxxx (hereinafter
called "ALCO"), represented for these purposes by Xx. Xxxxx Xxxxx,
and
SICOR Limited, 00 Xxxx Xxxxxx, Xxxxxx XX0 X0XX, Xxxxxxx (hereinafter called
"SICOR "), represented for these purposes by Xx. Xxxxxx Xxx Xxxxxx.
RECITALS
WHEREAS SICOR has entrusted SICOR Societa Italiana Corticosteroidi S.p.A., Rho
(Mi), Italy with the production of certain anti-neoplastic antibiotics on an
industrial scale and is interested in obtaining suitable micro-organisms and
related Technology to assist it in enlarging the scope of such production,
WHEREAS ALCO is willing to supply such a micro-organism and technology useful in
the production of such an antibiotic,
Now, THEREFORE, the parties have agreed as follows :
1) DEFINITIONS
-----------
(a) "MITOMYCIN C" shall mean :
the compound described in the United States Pharmacopoeia, XXI edition, page
699; which complies with the United States Pharmacopoeia and the Code Federal
Regulations effective as of the date of delivery of the STRAINS and TECHNOLOGY
as provided for in clause 3 below.
(b) "STRAIN" shall mean :
a micro-organism belonging to the genus Streptomyces as described in the
attached exhibit 1.
(c) "TECHNOLOGY" shall mean :
(i) information relating to the maintenance and reproduction of the STRAIN in
the laboratory as described in the attached Exhibit 2.
(ii) information relating to the utilization of the STRAIN to produce MITOMYCIN
C in the laboratory as described in the attached Exhibit 3.
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(d) "TERRITORY" shall mean : All countries world-wide except the People's
Republic of China.
(e) "IMPROVEMENTS" shall mean: All inventions, modifications and
discoveries, patented or not, related to the STRAIN and/or TECHNOLOGY which
enables MITOMYCIN C to be manufactured more efficiently or at a lower cost,
acquired or conceived, during the term of this Agreement.
2) LICENSE GRANT
-------------
ALCO hereby grants SICOR, subject to all the terms and conditions hereof, an
exclusive right and license to use the STRAIN and TECHNOLOGY and manufacture and
sell MITOMYCIN C in all the countries in the TERRITORY except the United States
of America and Japan.
Furthermore ALCO hereby grants SICOR subject to all the terms and conditions
hereof, a non-exclusive right and license to sell MITOMYCIN C in the People's
Republic of China.
ALCO represents and warrants that ALCO has full right to grant the license set
forth herein.
3) DELIVERY OF THE STRAIN AND TECHNOLOGY
-------------------------------------
Within 30 days of the effective date of this agreement, ALCO will deliver to
SICOR the STRAIN in lyophilized form and as a soil culture in three ampoules
each, together with the TECHNOLOGY as described in the attached Exhibits 1, 2,
and 3 in the English language in sufficient detail that experts in the art may
verify the guarantees as set forth in clause 4 below. This detailed TECHNOLOGY
will include complete instructions for STRAIN maintenance, propagation, media
composition, productivity testing in the laboratory, and isolation and
purification of MITOMYCIN C.
4) GUARANTEES
----------
(a) ALCO guarantees the efficiency of the STRAIN to produce the stipulated
amount of MITOMYCIN C as well as the recovery rate of MITOMYCIN C as specified
in attached Exhibits 1, 2, and 3 when the STRAIN is utilized in the manner
described in such Exhibits as well as the TECHNOLOGY described in the same
Exhibits and in clause 4 above provided SICOR Societa Italiana Corticosteroidi's
facilities have all the equipment listed in Exhibits 1, 2, and 3.
(b) In the event that the STRAIN should prove to be less than that
guaranteed in clause 4(a) above, ALCO shall be entitled to receive an additional
three (3) ampoules of the lyophilized form and soil culture in replacement of
the faulty STRAIN, provided that SICOR gives written notice to ALCO within
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four (4) months of the delivery of the STRAIN that the results of initial
testing of any ampoule of the STRAIN failed to meet the guaranteed efficiency,
accompanied by a written report on the results of such testing.
(c) In the event that either the replacement STRAIN as described in clause
4(b) above or the TECHNOLOGY as described in attached exhibits 2, and 3, and
clause 4 above shall fail to meet the guaranties as described in clause 4(a)
above, SICOR shall have the right of recourse to the Technical Arbitration as
described in clause 8 below, provided that SICOR gives written notice to ALCO
within four (4) months of the delivery of either the replacement STRAIN or the
TECHNOLOGY that the results of ALCO's verification of either the replacement
STRAIN and/or TECHNOLOGY failed to meet the guarantees as stipulated in clause
4(a) above, accompanied by a written report on the results of such verification.
(d) In the event that the decision of the Technical Arbitration finds in
favour of SICOR, SICOR shall be entitled to a reduction of the payments provided
for in clause 6 below according to the following formulae:
(i) in the event only on guarantee has not been met :
verified performance _ x 100 = % payable guaranteed performance
--------------------
(ii) in the event more than one guarantee has not been met
verified performance i x verified performance n x 100 =
-------------------- --------------------
guaranteed performance i guaranteed performance n
% payable
where "i" represents the first guarantee not met and "n" represents each
successive guarantee not met.
5) TECHNICAL ASSISTANCE
--------------------
Upon SICOR's request ALCO agrees to provide SICOR with all necessary technical
assistance for the start-up, and SICOR agrees to reimburse ALCO all expenses
incurred, without any extra fee.
6) PAYMENT AND PAYMENT TERMS
-------------------------
In consideration of the license to the STRAIN and TECHNOLOGY granted pursuant to
clause 2 above, ALCO shall receive from SICOR the sum of United States Dollars
Ninety thousand (US$ 90,000) to be paid by compensation with fifty percent (50%)
of the amount of SICOR's invoices to ALCO for the sale of COMPOUND pursuant to
clause 7 below.
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7) SUPPLY OF COMPOUND
------------------
In further consideration of the license to the STRAIN and TECHNOLOGY granted
pursuant to clause 2 above, SICOR agrees to sell MITOMYCIN C exclusively to
ALCO, and ALCO agrees to purchase MITOMYCIN C exclusively from SICOR for
distribution solely within the territory of the United States of America and
Japan. The terms and conditions of a supply agreement covering such sale and
purchase shall be defined separately.
8) RESTRICTIONS AND CONFIDENTIALITY
--------------------------------
Except as permitted herein, each party shall maintain in confidence and make no
use of any data or information disclosed to it by the other party hereunder.
Such undertaking shall, however, not apply to the extent the receiving party is
able to demonstrate that such data or information was already known to it prior
to disclosure hereunder, that such data or information was in the public domain
at the time of disclosure or subsequently became part of the public domain
through no fault of the receiving party, or that such data or information was
acquired by the receiving party from a third party having no secrecy obligation
to the disclosing party. Data and information disclosed prior to the execution
of this Agreement shall also be governed by the provisions hereof.
8) VERIFICATION BY INDEPENDENT EXPERTS
-----------------------------------
In the event of any dispute which cannot be amicably resolved between the
parties hereto as to whether or not any one or more of the guarantees indicated
in clause 4 above has been met, SICOR shall be entitled to appoint an
internationally qualified independent expert in accordance with the
International Chamber of Commerce's Rules for Technical Expertise to witness a
re-testing of the STRAIN and/or TECHNOLOGY in question in SICOR's laboratory.
ALCO shall be entitled to appoint its own representative to attend such re-
testing. The independent experts' decision as to whether or not the guarantee
in question has been met shall be final and binding. The costs of such
verification shall be shared equally by SICOR and ALCO.
9) IMPROVEMENTS
------------
If during the validity of this agreement, ALCO should acquire any IMPROVEMENTS
in either the STRAIN and/or TECHNOLOGY, SICOR shall have the right of first
refusal to such improvements under terms and conditions to be agreed upon by
SICOR and ALCO. If SICOR elects to exercise such a right the conditions
particularly with regard to the exclusivity will be essentially the same as
those contained in this Agreement.
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10) FORCE MAJEURE
-------------
Except with respect to the payment of any monies due hereunder, neither party
shall be liable or be in breach of any provision of this Agreement for any
failure or delay on their part to perform any obligation hereunder because of
force majeure or any other cause beyond the control of such party including
without limitation, strikes, lockouts, technical problems/disturbances in the
production, and shortage of raw materials or energy, legal restrains or
governmental or authorities' regulations/actions provided that such party shall
promptly give notice to the other party of such occurrence, and shall move to
eliminate the effect thereof to the extent possible and with all reasonable
dispatch.
11) TERM AND TERMINATION
--------------------
a) This Agreement shall become effective on the date of
the last signature to this Agreement.
b) This Agreement shall continue for a period of ten (10) years from the
date of the last signature to this Agreement.
c) In case a condition of force majeure continues for a period of three
(3) months or more, the parties shall meet and decide the future course of
action. In the event that no settlement is concluded regarding future course of
action, the party not claiming force majeure shall be entitled to terminate this
Agreement by giving thirty (30) days' notice in writing to that effect to the
other party.
12) BREACH OF AGREEMENT
-------------------
Notwithstanding the provisions of clause 11 above, either party shall be
entitled to terminate this Agreement forthwith by written notice to the other
upon the happening of anyone of the following events :
a) If the other party breaches or fails to observe or perform any of its
material obligations under this Agreement and shall fail to cure such breach
during a period of sixty (60) days after receipt of written notice from the
offended party. If the other party fails to cure the breach, then the party who
has given notice may terminate the Agreement with one month's written notice
without prejudice to any other rights.
b) If the other party is a corporation and there is a change in the
effective ownership or control of that corporation which would materially and
detrimentally affect the interests of the party wishing to terminate.
c) If the other party becomes subject to winding-up proceedings or
procedure or suffers the appointment of an official inspector, a receiver,
manager or provisional
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liquidator, or becomes insolvent or commits an act of bankruptcy.
13) COMPENSATION
------------
No compensation shall be payable in consequence of a termination of this
agreement pursuant to clause 10. However, should this Agreement be terminated
by reason of breach of agreement pursuant to clause 12, the party terminating
this Agreement shall be entitled to seek recovery of the damages suffered by him
as a result of the breach.
14) NOTICES
-------
All notices, communications, demands and payments under this Agreement shall be
in writing and shall conclusively be presumed to be given or made at the time
they are personally given or made, or at the time of sending if sent by telex of
telefacsimile, or ten days after mailing if sent by registered or certified air
mail (return receipt registered) as evidenced by the postmark at the point of
mailing, or three days after they are placed in an envelope and deposited with a
reputable international courier service for express delivery, addressed as
follows :
If to ALCO
Alco Chemicals Ltd.,
000 Xxxxxxx Xxxx,
Xxxxxx,
Xxxxxxxxx XX0 OPS
England
Attention : Managing Director
Telex : 265871 MONREF G
Telefax : (00000) 000 0000
If to SICOR
SICOR Limited,
00 Xxxx Xxxxxx,
Xxxxxx XX0 X0XX
Xxxxxxx
Attention : Chairman
Telex : 884587 G
Telefax : (00000) 000 0000
or to such other person or address as either party may, by notice, specify to
the other.
15) VARIATIONS AND AMENDMENTS
-------------------------
Variations, alterations and additions to this Agreement shall only be deemed to
have become part of this Agreement when it is specifically stated that it has
become part of this Agreement
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and has been signed by both parties. This Agreement sets forth the entire
understanding and supersedes and replaces any and all prior negotiations,
discussions or agreements of the parties as to such subject matter, oral or
written.
16) WAIVER
------
No failure or delay of any party to exercise any right, power or privilege
hereunder, shall operate as waiver, nor shall the waiver of any right or default
hereunder be a waiver of any right on a continuing default or a subsequent
default of a similar nature.
17) ASSIGNMENT
----------
Without the mutual written agreement of the parties hereto, this Agreement shall
not be assignable.
18) CAPTIONS
--------
The captions of the respective clauses of this Agreement are for convenience
only and do not constitute a part of this Agreement and shall be disregarded in
construing this Agreement.
19) PARTIAL INVALIDITY
------------------
Should any part of this Agreement be rendered invalid or unenforceable, such
rendering shall not affect the validity or enforceability of the remainder,
unless the part so rendered invalid or unenforceable impairs the value of the
whole Agreement to either party. Subject to this, such part shall be re-
negotiated between the parties in such a way as to render the same valid and to
achieve its purposes to the extent valid and enforceable
20) LAW
---
a) This Agreement shall be governed by and construed in accordance with
the substantive laws for the time being in force in the England.
b) Any dispute of difference between the parties arising out of, or in
connection with this Agreement which the parties cannot resolve amicably or by
recourse to the I.C.C.'s International Center for Technical Expertise as
provided in clause 8 shall be finally resolved by arbitration in London in
accordance with the Rules and Regulations of the International Chamber of
Commerce by three arbitrators appointed in accordance
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with such rules and judgement on the award may be entered by any Court having
jurisdiction thereof.
IN WITNESS WHEREOF both parties have caused this Agreement to be signed by their
respective duly authorized officers or representatives on the dates indicated
below.
For and on behalf of
ALCO CHEMICALS Limited SICOR Limited
By: /s/ Xxxxx Xxxxx By: /s/ Xx. Xxxxxx Xxx Xxxxxx
---------------- ---------------------------
Xx. Xxxxx Xxxxx Xx. Xxxxxx Xxx Xxxxxx
Managing Director Director
Date: January 9th, 1989 Date: January 9th, 1989
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EXHIBITS 1 AND 2
[CONFIDENTIAL TREATMENT REQUESTED]
9
[CONFIDENTIAL TREATMENT REQUESTED]
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EXHIBIT 3
[CONFIDENTIAL TREATMENT REQUESTED]
11
Table 1. The cultural characteristics of
[CONFIDENTIAL TREATMENT REQUESTED]
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LICENSE AGREEMENT - ADDENDUM NO. 1
----------------------------------
between
ALCO CHEMICALS LTD., 000 Xxxxxxx Xxxxxx, Xxxxxx X0X 0XX, Xxxxxxx (hereinafter
"ALCO"), represented for these purposes by Xx. Xxxxx Xxxxx,
and
SICOR - SOCIETA ITALIANA CORTICOSTEROIDI SPA, Rho (MI), Italy (hereinafter
"SICOR SPA"), represented for these purposes by Xx. Xxxxxxx Xxxxx.
WHEREAS ALCO has stipulated a License Agreement dated January 9th, 1989
(hereinafter the "License Agreement"), with SICOR LIMITED, London, England.
WHEREAS ALCO has been informed that as a result of the restructuring of the
companies part of the SICOR group, SICOR SPA has assumed all rights,
obligations, benefits and interest of SICOR LIMITED under the License Agreement.
The said restructuring was carried out, with respect to the License Agreement,
in agreement with ALCO.
WHEREAS ALCO and SICOR SPA wish to modify certain terms and conditions of the
License Agreement.
NOW THEREFORE the parties hereby agree as follows:
(1) SICOR SPA hereby confirm to ALCO that in accordance with the agreements
reached and arrangements made in the context of the restructuring of the
SICOR group companies, SICOR SPA has assumed and acquired all of SICOR
LIMITED's rights, obligations, interest and benefits under the License
Agreement. SICOR SPA hereby confirms being fully aware of the terms and
conditions of the License Agreement and expressly confirms its approval
thereof and its undertaking to be bound by the said terms and conditions as
were previously applicable to SICOR LIMITED.
ALCO hereby expressly confirms its unconditional agreement with the said
assumption and acquisition by SICOR SPA and hereby acknowledges its
acceptance of SICOR SPA as counterpart under the License Agreement and
agrees that it will have no further claims towards SICOR LIMITED arising
under the License Agreement.
(2) In consideration of the surrogation as foreseen in section 1 hereof, all
reference in the License Agreement to "SICOR" shall be deemed reference to
"SICOR SPA".
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(3) ALCO and SICOR SPA agree that section 6) PAYMENT AND PAYMENT TERMS of the
-------------------------
License Agreement shall be deemed modified to include the following new
paragraph:
quote
On the other hand, in order to partially cover the expenses incurred by
SICOR SPA for the development of the process for the manufacture of
MITOMYCIN C, and moreover in consideration of the undertaking of SICOR SPA
to provide ALCO, free of charge, with a certain quantity of MITOMYCIN C in
order to allow ALCO to obtain marketing license approval in the United
States of America and in Japan, ALCO has agreed to pay to SICOR SPA an
amount of US$ 1'000'000.-- (US Dollars one million) to be paid as follows:
- US$ 400'000.-- (US Dollars four hundred thousand) on July 31st, 1992; -
US$ 400'000.-- (US Dollars four hundred thousand) on December 31st, 1992; -
US$ 200'000.-- (US Dollars two hundred thousand) on March 31st, 1993.
unquote
(4) ALCO and SICOR SPA agree that section 7) SUPPLY OF COMPOUND of the License
------------------
Agreement shall be deemed modified to include the following new paragraph:
quote
SICOR SPA agrees and undertakes to provide ALCO, free of charge, with 750
grammes of MITOMYCIN C in order to allow ALCO to obtain marketing license
approval in the United States of America and in Japan.
unquote
(5) ALCO and SICOR SPA agree that section 14) NOTICES of the License Agreement
-------
shall be deemed modified in so far as the address of SICOR LIMITED shall be
replaced by the address of SICOR SPA to read as follows:
quote
If to SICOR SPA
SICOR - Societa Italiana Corticosteroidi S.p.A.
xxx Xxxxxxxxxx, 00
00000 XXX (Xxxxx)
XXXXX
Att: Xx. Xxxxxxx Xxxxx
Telex: 325814 sicor i
Telefax: (00000) 0000000
14
unquote
(6) Terms and expressions used herein shall, unless otherwise determined, have
the same meaning as defined in the License Agreement.
(7) Except as expressly provided herein all other terms and conditions of the
License Agreement remain unchanged, valid and in full force and effect.
(8) The present Addendum shall constitute an integral part of the License
Agreement and shall be construed and interpreted in accordance therewith.
(9) The present Addendum shall be deemed to have entered into effect as of
January 1st, 1992.
IN WITNESS WHEREOF the parties hereto have caused this Addendum to be duly
executed this 16th day of June, 1992.
ALCO SICOR SPA
---- ---------
ALCO CHEMICALS LTD. SICOR
Societa Italiana Corticosteroidi S.p.A.
/s/ Xxxxx Xxxxx /s/ Xxxxxxx Xxxxx Xxxxx
----------------------- ------------------------------
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ADDENDUM NO. 2, dated as of October 31, 1996, between ALCO CHEMICALS
LTD., a corporation organized under the laws of Guernsey, Channel Islands
("Alco"), and SICOR Societa' Italiana Corticosteroidi S.p.A., a corporation
organized under the laws of Italy ("SICOR"), to the License Agreement, dated
January 9, 1989, between Alco and SICOR, as successor to SICOR Limited, as
amended by Addendum No. 1, dated June 16, 1992, between ALCO and SICOR (as to
amended, the "License Agreement").
W I T N E S S E T H:
WHEREAS, Alco and SICOR, as successor in interest to SICOR Limited,
are parties to the License Agreement; and
WHEREAS, Section 7 (Supply of Compound) of the License Agreement
provides, among other things, that SICOR shall only sell Mitomycin C
("Mitomycin") to customers in the United States of America or Japan through
Alco; and
WHEREAS, SICOR, with the consent of Alco, has delivered Mitomycin to
customers located in the United States of America, without selling through Alco;
and
WHEREAS, SICOR has requested that the License Agreement be modified to
reflect the understanding between SICOR and Alco; and
WHEREAS, Alco is willing to amend the License Agreement, as more fully
set forth herein;
NOW, THEREFORE, the parties hereto hereby agree as follows:
(10) Defined Terms. Terms defined in the License Agreement as amended
-------------
hereby shall have their respective defined meaning when used herein.
(11) Amendment to Section 1 (Definitions). Section 1 (Definitions) of
------------------------------------
the License Agreement is hereby amended by deleting it its entirely paragraph
(a) of such section and substituting in lieu thereof the following:
"(a) 'MITOMYCIN C' shall mean:
the compound described in the United States Pharmacopoeia, XXI
edition, page 699; which complies with the United States Pharmacopoeia
and the Code of Federal Regulations effective as of the date of
delivery of the STRAIN and TECHNOLOGY, as provided in clause 3 below,
and which is manufactured from the STRAIN employing the TECHNOLOGY."
(12) Amendment to Section 2 (License Grant). Section 2 (License Grant) of
--------------------------------------
the License Agreement is hereby amended by deleting in its entirely the first
paragraph of such section and substituting in lieu thereof the following:
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"ALCO hereby grants SICOR, subject to all the terms and conditions
hereof, an exclusive right and license to use the STRAIN and
TECHNOLOGY and to manufacture and sell MITOMYCIN C in all the
countries of the TERRITORY except Japan."
(13) Amendment to Section 7 (Supply of Compound). Section 7 (Supply
-------------------------------------------
of Compound) of the License Agreement is hereby amended by deleting such section
in its entirety and substituting in lieu thereof the following:
"In further consideration of the license to the STRAIN and TECHNOLOGY
granted pursuant to clause 2 above, SICOR agrees to sell MITOMYCIN C
to ALCO, and ALCO agrees to purchase MITOMYCIN C from SICOR. The
terms and conditions of any such supply agreement covering any such
sale and purchase shall be defined separately.
SICOR agrees to provide ALCO, free of charge, with an amount of up to
750 grams of MITOMYCIN C in order to allow ALCO to obtain marketing
license approval in the United States of America and in Japan."
(14) Effective Date of Amendment. This Addendum No. 2 shall have
---------------------------
effect from January 9, 1989, and the License Agreement shall be deemed amended
as herein provided effective as of such date.
(15) Waiver. Notwithstanding the foregoing, Alco hereby waives any
------
and all breaches of, or defaults under, the License Agreement which may have
occurred, during, or which may arise from, the period from the date of the
License Agreement to the date hereof.
(16) No Other Amendments; Confirmation. Except as expressly amended,
---------------------------------
modified and supplemented hereby, the provisions of the License Agreement shall
remain in full force and effect.
(17) Governing Law. This Addendum No. 2 shall be governed by, and
-------------
construed and interpreted in accordance with, the laws of England.
(18) Counterparts. This Addendum No. 2 may be executed in any number
------------
of counterparts (including on separate counterparts), all of which counterparts,
taken together, shall constitute one and the same instrument. This Addendum No.
2 may be delivered by facsimile transmission of the relevant signature pages
hereof.
IN WITNESS WHEREOF, the parties hereto have caused this Addendum No. 2 to
the duly executed and delivered by their respective proper and duly authorized
officers as of the day and year first above written.
ALCO CHEMICAL LTD.
By /s/ Xxxxx Xxxxx
---------------------------
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Name: Xxxxx Xxxxx
Title: Attorney in Fact
SICOR SOCIETA' ITALIANA
CORTICOSTEROIDI S.P.A.
By /s/ Xx. Xxxxxxxxx Xxxxx
--------------------------
Name: Xx. Xxxxxxxxx Xxxxx
Title: Managing Director
By /s/ Xx. Xxxxxxx Xxxxx
-------------------------
Name: Xx. Xxxxxxx Xxxxx
Title: Technical Director
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