EXHIBIT 10.56
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and
240.24b-2(b)(1)
BY AND
BETWEEN THE UNDERSIGNED :
IDM
Immuno-Designed Molecules, a French société anonyme with
a capital of 1 164 736.90 Euros having its principal place of
business at 172 rue de Charonne, Paris (75011) and registered
at the Paris Register of Trade and Companies under B 382 632 263
represented by Jean-Loup Romet-Lemonne, President, and Bernard
Brigonnet, General Director (hereinafter,
“IDM”).
SANOFI-SYNTHELABO, a French société
anonyme with a capital of 1 462 883 492 Euros having its principal
place of business at 174, avenue de France, 75013 Paris, and
registered at the Paris Register of Trade and Companies under B 395
030 844, represented by Jean-Claude Leroy, Senior Vice President
Strategy and Business Development and José Ferrer, Director
Operations Legal Affairs (hereinafter
“SANOFI-SYNTHELABO”);
When used in
this IL-13 agreement, capitalized terms have the meaning assigned
in Article 1 of this IL-13 agreement.
Whereas IDM is
a biotechnology company incorporated in 1993 that, since inception,
has developed a Know-how and expertise in the field of
immunotherapy, and particularly in the field of ex vivo cancer
treatments in humans.
Whereas
SANOFI-SYNTHELABO is a pharmaceutical company that develops,
manufactures and/or markets pharmaceutical products in the field of
human health on a worldwide basis. In the course of its R&D, it
discovered and developed a cytokine known as Interleukin 13 («
IL-13 »), for which it applied for and obtained patents and
developed Know-how.
Whereas, on
July 13, 1999, SANOFI-SYNTHELABO and IDM entered into an
agreement (« the 1999 Agreement ») defining the terms and
conditions under which SANOFI-SYNTHELABO granted IDM a
non-exclusive license to its IL-13 Intellectual Property rights
relative to the IL-13 cytokine, in return for SANOFI-
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SYNTHELABO’s taking a stake in the capital
of IDM, along with an exclusive marketing option for
SANOFI-SYNTHELABO in the event developments carried out by IDM are
successful.
Whereas in
application of the 1999 Agreement, the Parties executed on
July 13, 1999 a contribution agreement (the «
Contribution Agreement ») pursuant to which SANOFI-SYNTHELABO
contributed to IDM the following assets, valued at [...***...]
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(a)
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full ownership [...***...] of IL-13
(non GMP) equivalent to a minimum of [...***...] biological
activity units of IL-13.
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(b)
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a
non-exclusive right to use the IL-13 Intellectual Property for the
purpose of using, implementing, developing, exploiting in all forms
and by all means the IL-13 Intellectual Property and, in
particular, IL-13 products resulting from that Intellectual
Property, exclusively in the field of ex vivo therapy for the
purpose of carrying out Phase I and Phase II Studies in one or more
Development Programs involving an IL-13 Product and for the
marketing of IL-13 Research Kits during Phase I and II
Studies.
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(c)
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a
non-exclusive right to use, under certain conditions, the IL-13
Intellectual Property for the purpose of using, implementing,
developing, exploiting in all forms and by all means the IL-13
Intellectual Property and, in particular, IL-13 products resulting
from that Intellectual Property exclusively in the field of ex vivo
therapy in order to carry out Phase III Studies in one or more
Development Programs involving an IL-13 Product.
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(d)
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a
non-exclusive right to use, under certain conditions, the IL-13
Intellectual Property for the purpose of using, implementing,
developing, exploiting in all forms and by all means the IL-13
Intellectual Property and, in particular, IL-13 products resulting
from that Intellectual Property exclusively in the field of ex vivo
therapy for the marketing of Final IL-13 Products.
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Whereas IDM and
SANOFI-SYNTHELABO having expressed their desire to strengthen their
collaboration in the field of ex vivo cellular therapies for humans
executed on July 20, 2001 a memorandum of agreement pursuant
to which SANOFI-SYNTHELABO has a priority right, on the terms and
conditions defined in this memorandum of agreement, to all IDM
Development Programs in the area of ex vivo cellular therapy in
humans, whether or not they require IL-13 (hereinafter, « the
2001 Agreement »).
The Parties
further wished to revise certain provisions of the 1999 Agreement
and agreed, in Article 8 of the 2001 Agreement, on general
principles that are to apply to the amendment to the 1999
Agreement.
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Confidential Treatment
Requested
under 17 C.F.R. §§ 200.80 (b) (4) and
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240.24b-2(b)(1)
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In view of the
complexity created by the coexistence of these two agreements, the
1999 Agreement and the 2001 Agreement, the Parties hereby agree to
amend the 1999 Agreement and to make more explicit certain
provisions of this Agreement.
This IL-13
Agreement constitutes the amendment to the 1999 Agreement specified
in Article VIII of the 2001 Agreement.
NOW,
THEREFORE, THE PARTIES MUTUALLY AGREE AS
FOLLOWS:
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1.1.
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ABSA shall mean 7.283 class B shares with
attached B-share subscription warrants issued by IDM to
SANOFI-SYNTHELABO and fully paid up through the Contribution, at
the Extraordinary Shareholders’ Meeting of IDM held on
January 7, 2000.
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1.2.
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1999 Agreement
shall mean the
memorandum of agreement executed by the Parties on July 13,
1999.
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1.3.
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IL-13 Agreement shall mean this Agreement,
including all its Attachments.
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1.4.
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2001 Agreement
shall mean the
memorandum of agreement executed by the Parties on July 20,
2001.
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1.5.
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Affiliate shall mean any entity controlled by
a Party, controlling that Party or under the same control as that
Party, in each case either directly or indirectly. For the needs of
this definition, “control” means the holding (directly
or indirectly through an Affiliate) of more than 50% of the capital
or voting rights of a company. The status of an Affiliate is
determined as of the date on which this definition needs to be
used.
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1.6.
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MA (AMM) or Marketing
Approval shall mean the official approval to
market a Final IL-13 Product granted by the relevant health
authority in each country in the Territory or each group of
countries in the Territory.
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1.7.
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Reference MA shall mean any MA granted
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–
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for
the territory of the United States of America ; or
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–
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for
the territory of Japan ; or
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–
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for
the territories of at least three of the following five countries :
France, Germany, the United Kingdom, Italy, or Spain ;
or
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issued by the European Drug Agency
(EMEA) for the marketing of any of the Final IL-13 Products on
the territory of countries that recognize the competence of that
agency.
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1.8.
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Contributions
shall mean contributions
in kind entailing full title and ownership (as recalled in the
recitals of this agreement) made by SANOFI -SYNTHELABO under the
1999 Agreement, and more specifically, the Contributions
Agreement.
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1.9.
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Amendment to the IL-13 License
Agreement shall mean the amendment to the
IL-13 License Agreement to be executed by the Parties, on terms and
conditions specified in Article 6.3.2, and a model of which is set
forth in Attachment 6.3.2.
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1.10.
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IL-13 Patents
shall mean patent
applications and patents belonging to SANOFI-SYNTHELABO, a
descriptive list of which is given in Attachment 1.10, including
all divisions, continuations in part and extensions of said
patents, certificates of addition, certificates of utility and
supplementary certificates of protection.
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1.11.
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BSA 1 warrants
shall mean 7,283 B-share
subscription warrants attached to the ABSA granting the right to
subscribe 161,860 (or 8,093 multiplied by 20 following the 20 split
approved by the Extraordinary Shareholders’ Meeting held on
June 21, 2001) new IDM B-shares by exercise of Option 1 for a
total price of [...***...].
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1.12.
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BSA 2 warrants
shall mean 7,283 B-share
subscription warrants attached to the ABSA granting the right to
subscribe 242,800 (or 12,140 multiplied by 20 following the 20
split approved by the Extraordinary Shareholders’ Meeting
held on June 21, 2001) new IDM B-shares by exercise exercise
of Option 2 for a total price of [...***...].
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1.13.
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Change of Control of IDM
shall mean the transfer
of shares and/or other financial instruments in any form
whatsoever, which effect is to cause a Third Party who was not an
IDM shareholder on the effective date of the 1999 Agreement, to
hold directly or indirectly more than 50% of the capital and/or
voting rights of IDM. Attachment 1.13 contains a list of IDM
shareholders as of the effective date of the 1999
Agreement.
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1.14.
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IL-13 Net Sales
shall mean net sales
before taxes made by IDM and/or by any authorized IDM licensee
(except SANOFI-SYNTHELABO) in connection with the Final IL-13
Products and/or the IL-13 Research Kits after deduction of
discounts, reductions and rebates granted to Third Parties, the
cost of Final IL-13 Products or IL-13 Research Kits returned,
commissions paid, miscellaneous taxes paid on the sale of Final
IL-13 Products or IL-13 Research Kits, market access costs and
custom duties
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*
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Confidential Treatment
Requested
under 17 C.F.R. §§ 200.80 (b) (4) and
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240.24b-2(b)(1)
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as
well as transport and insurance costs relative to these sales,
except Final IL-13 Products or IL-13 Research Kits used by IDM or
by any IDM sublicensee for internal purposes — training,
development, studies, research — within the context of its
(their) activities.
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1.15.
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Executive Committee
shall mean the executive
committee referred to in Article 4.1(a) of the 2001
Agreement.
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1.16.
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IL-13 License Agreement
shall mean the license
contact that is to be executed by the Parties on the terms and
conditions specified in Article 6.2.2, a model of which is
given in Annex 6.2.2.
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1.17.
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Not
applicable
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1.18.
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Effective Date
shall mean the date the
2001 Agreement takes effect.
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1.19.
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Implementation Date
shall mean
January 7, 2000.
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1.20.
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Phase I Study (Studies)
shall mean, within the
context of a given IL-13 Development Program, all tolerance studies
of an IL-13 Product as well as any pharmacodynamic study relative
to said IL-13 Product conducted by IDM in treated
patients.
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1.21.
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Phase II Study (Studies)
shall mean, within the
context of a given IL-13 Development Program, all studies conducted
by IDM to demonstrate clinical activity of the IL-13 Product in
treated patients.
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1.22.
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Phase III Study (Studies)
shall mean, within the
context of a given IL-13 Development Program, all studies conducted
by IDM to confirm the efficacy and evaluate the long-term tolerance
of an IL-13 Product in order to obtain Marketing Approval for the
Final IL-13 Product in the Countries of the Territory.
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1.23.
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Exercise of Option 1
shall mean the
occurrence of one of the events referred to in
Article 6.2.2.
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1.24.
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Exercise of Option 2
shall mean the obtaining
of a Reference MA.
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1.25.
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IL-13 shall mean the protein with human
cytokinic activity, cloned and discovered by SANOFI-SYNTHELABO as
more precisely described in Annex 1.25.
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1.26.
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IL-13 Research Kits
shall mean the IL-13
Product or Products, in any form whatsoever, (i) developed in
whole or in part by IDM and/or any authorized IDM sublicensee
within the scope of this IL-13 Agreement, and which manufacture
and/or marketing and/or utilization is covered by one or
more
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IL-13 Patents and (ii) marketed
for one or more of the following uses (a)
for research purposes
only without therapeutic use, and/or (b)
for clinical trial
purposes and without therapeutic use except as it results naturally
from such clinical trials.
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1.27.
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Development Offer
shall mean the offer
that IDM must make to SANOFI-SYNTHELABO in application of
Article III of the 2001 Agreement in order to allow the latter
to exercise, or not, its Development Option right.
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1.28.
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Development Option
shall mean the
irrevocable option enjoyed by SANOFI-SYNTHELABO pursuant to
Article III of the 2001 Agreement granting it, if it exercises
the option with regard to a given Development Program, exclusive
rights to benefit from the exploitation of the results of the
corresponding Development Program, in return for its financing of
the costs and expenses relative to said Development
Program.
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1.29.
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Exclusive License Option
shall mean the
irrevocable option enjoyed by SANOFI-SYNTHELABO pursuant to
Article VI of the 2001 Agreement.
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1.30
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IDM Shareholders’
Agreement shall mean the shareholders’
agreement among IDM’s shareholders dated December 29,
1996 and amended on August 31, 1998, October 29, 1998,
January 7, 2000 and October 6, 2000, and, if applicable, any
subsequent additional amendment.
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1.31.
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Parties shall mean SANOFI-SYNTHELABO and IDM
collectively (each of the Parties being individually designated as
a “ Party ”).
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1.32.
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Improvements shall mean any improvements and
upgrades made to the IL-13 Intellectual Property, whether or not
they are covered by patents or certificates of utility or any other
intellectual property title.
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1.33.
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IL-13 Product
shall mean any Product,
as defined in Article 1.18 of the 2001 Agreement, that
includes a dendritic cell obtained using IL-13.
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1.34.
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Final IL-13 Product
shall mean any Final
Product, as defined in Article 1.19 of the 2001 Agreement,
that pertains to an IL-13 Product.
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1.35.
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Development Program
shall mean, for a given
Product in a specified therapeutic indication, all pre-clinical
studies and clinical studies carried out or to be carried out by
IDM and necessary for the preparation of MA applications in the
Territory. IL-13 Development Program shall mean any
Development Program pursuant to this definition that pertains to an
IL-13 Product. For information, Annex 1.35 contains a list of the
IL-13 Development Programs currently in progress. The term
SANOFI-SYNTHELABO IL-13 Development Program shall mean an
IL-13 Development Program as to which SANOFI-SYNTHELABO has
exercised
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its Development
Option right per Article III of the 2001 Agreement and that
has not been interrupted in accordance with the provisions of the
2001 Agreement.
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1.36.
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IL-13 Intellectual
Property shall mean, collectively, the IL-13
Patents, the IL-13 Know-How, as well as any intellectual property
right that SANOFI-SYNTHELABO might have, either before or after the
date of signature of the 1999 Agreement, and/or that is freely
available to it and that is necessary (i) for the marketing of
the IL-13 Research Kits or (ii) for the implementation of the
IL-13 Development Programs and (iii) the marketing of the
Final IL-13 Products.
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1.37.
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IL-13 Know-How
shall mean all
knowledge, experience and experimentation, information and expert
reports relative to IL-13 and to the inventions claimed in the
IL-13 Patents, that SANOFI-SYNTHELABO developed, as well as those
to which it had access, provided they were freely available to it
and provided they existed in any physically transmissible form on
the execution date of the 1999 Agreement .
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1.38.
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Territory shall mean the entire
world.
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1.39.
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Third Party shall mean any individual or any
legal entity except the Parties and their Affiliates.
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The purpose of
this IL-13 Agreement is:
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(a)
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to
amend the conditions under which IDM will be supplied with
IL-13;
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(b)
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to
specify the terms of the IL-13 Intellectual Property license
granted by SANOFI-SYNTHELABO to IDM for (i) marketing IL-13
Research Kits, (ii) implementation of IL-13 Development
Programs and (iii) marketing Final IL-13 Products.
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This IL-13
Agreement cancels and replaces, as of the Effective Date, the
provisions of the 1999 Agreement with the exception of the
Contributions Contract.
Further to the
decision made by SANOFI-SYNTHELABO to stop supplying IL-13 to IDM,
SANOFI-SYNTHELABO hereby grants IDM, which accepts it, a free
non-exclusive license to the IL-13 Intellectual Property and
Improvements, to the
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extent they are
necessary for the manufacturing of IL-13, in order to enable IDM to
manufacture, for its own exclusive use, the required amounts of
IL-13 to carry out IL-13 Development Programs and marketing of
Final IL-13 Products.
This license
includes the right for IDM to sub-license the IL-13 Intellectual
Property and Improvements, to the extent the latter are necessary
for the manufacturing of IL-13, to one (or more) Third Parties,
provided that (i) the Third Party or Parties are pre-approved
by SANOFI-SYNTHELABO, which may not refuse its consent without a
serious reason, and (ii) IDM concludes with the Third Party or
Parties a license contract which terms and conditions are
consistent with the provisions of this Article 3.
ARTICLE 4
— NON-EXCLUSIVE NATURE OF GRANTED RIGHTS
IDM declares
that it knows and accepts the fact that the rights granted by
SANOFI-SYNTHELABO to IDM to the IL-13 Intellectual Property under
this IL-13 Agreement are not exclusive.
ARTICLE 5
— CANCELLATION OF THE EXCLUSIVE MARKETING
OPTION
The exclusive
marketing option right enjoyed by SANOFI-SYNTHELABO under
Article 8.2.2. of the 1999 Agreement is hereby
cancelled.
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6.1.
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Marketing of IL-13 Research
Kits
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IDM
may market IL-13 Research Kits during the life of this IL-13
Agreement, of the IL-13 License Agreement and of the Amendment to
the IL-13 License Agreement. In this case, IDM shall pay
SANOFI-SYNTHELABO a royalty equal to [...***...] of Net Sales made
by IDM under such marketing.
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It
is specified that [...***...] of the above referenced royalty is in
consideration of the license granted to the IL-13 Patents and
[...***...] is in consideration of the license granted for the
IL-13 Knowhow, this royalty being only due during the life of this
IL-13 Agreement.
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The
payment by IDM of the amounts due under this Article 6.1 shall
be made twice a year, on the last working day of the months of
February and August of each year, by bank transfer to the account
specified by SANOFI-SYNTHELABO. Each payment shall include a
statement of IL-13
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*
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Confidential Treatment
Requested
under 17 C.F.R. §§ 200.80 (b) (4) and
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240.24b-2(b)(1)
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Research Kits sales made during the
corresponding six calendar months that makes it possible to
identify the amounts payable.
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IDM
shall have a special accounting procedure, with the corresponding
substantiating documents, covering all elements necessary for
calculating the amounts owed to SANOFI-SYNTHELABO pursuant to the
above provisions. SANOFI-SYNTHELABO may cause IDM’s books to
be verified, at its simple request made with sufficient advance
notice, by an independent expert jointly chosen by the Parties and,
absent an agreement within fifteen (15) days of the date on
which SANOFI-SYNTHELABO has requested the audit, by the Presiding
Judge of the Lower Court of Paris on the petition of the first
acting Party. The expert shall use its best efforts to notify his
findings within a period of thirty (30) days after referral.
The findings of this expert shall be final and without recourse.
The expert’s fees and costs will be covered by
SANOFI-SYNTHELABO except if the total amount owed to
SANOFI-SYNTHELABO is more than five per cent (5%) greater than the
amount reported by IDM, in which case these costs and fees shall be
covered by IDM.
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6.2.
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Implementation of IL-13 Development
Programs — Exercise of BSA 1 warrants
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6.2.1.
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Phase I and II
studies
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Except for SANOFI-SYNTHELABO IL-13
Development Programs that are governed by the 2001 Agreement, IDM
agrees to implement and pursue the Phase I and II Studies of the
IL-13 Development Programs at its sole expense. IDM will use its
best efforts to complete the Phase I and II Studies at the earliest
possible time compatible with applicable legal and regulatory
requirements.
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IDM
will provide SANOFI-SYNTHELABO with a summary report of the results
of the Phase II Studies carried out on one or more IL-13 Products
within six (6) months following completion of these Phase II
Studies.
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6.2.2.
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Exercise of the BSA 1
warrants
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The
occurrence of one of the following events shall be deemed to be
equivalent to Exercise of Option 1 as specified in the provisions
for the exercise of BSA 1s described in Annex 7:
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Events:
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(a)
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The
Executive Committee decides to undertake a Phase III Study on an
IL-13 Product in application of Article 5.4.a) (ii) of
the 2001 Agreement. In that event, Option 1 shall be deemed to have
been
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exercised on the date of signature of the joint
report setting forth the decision of the Executive Committee to
start a Phase III Study; or
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(b)
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IDM
decides to undertake a Phase III Study on an IL-13 Product that is
not covered by a SANOFI-SYNTHELABO IL-13 Development Program. In
that event, IDM shall notify SANOFI-SYNTHELABO of its decision to
start Phase III Studies by registered mail with return receipt sent
within six (6) months of the completion of the Phase II
Studies carried out on such IL-13 Product. Option 1 shall be deemed
to have been exercised on the date of the first presentation to
SANOFI-SYNTHELABO of such registered mail with return
receipt.
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Within thirty (30) days from
the occurrence of one of the above events, the Parties agree to
enter into an IL-13 License Agreement pursuant to the model
contained in Annex 6.2.2., defining (i) the terms and
conditions under which IDM may use and exploit the IL-13
Intellectual Property to carry out Phase III Studies on IL-13
Products and (ii) the terms and conditions of the payment for
the IL-13 Intellectual Property license thus granted by
SANOFI-SYNTHELABO. The IL-13 License Agreement shall take effect as
of the Exercise date of Option 1. On the date of execution of the
IL-13 License Agreement, SANOFI-SYNTHELABO shall submit to IDM an
invoice for the amount specified in Article 4.1.1. of the
IL-13 License Agreement, plus any applicable amount of value-added
tax, as well as a simplified subscription form requesting exercise
of the BSA 1 warrants
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Within thirty (30) days of the
signing of the IL-13 License Agreement, IDM shall cause its Board
of Directors to draw up a statement of account, to be certified by
its auditors, and the Board of Directors shall acknowledge issuance
of the shares resulting from the exercise of the BSA 1
warrants.
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6.2.3.
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Phase III Studies
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Except for
SANOFI-SYNTHELABO IL-13 Development Programs that are governed by
the 2001 Agreement:
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IDM
agrees to carry out at its sole expe
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