Document:

Exhibit 10.56

 

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)

IL-13 AGREEMENT

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”).

AND:

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.

RECITALS :

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 [...***...] :

	 	(a)	 	full ownership [...***...] of IL-13 (non GMP) equivalent to a minimum of [...***...]
biological activity units of IL-13.
	 
	 	(b)	 	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.
	 
	 	(c)	 	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.
	 
	 	(d)	 	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.

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.

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

2

 

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:

ARTICLE 1 — DEFINITIONS

	1.1.	 	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.
	 
	1.2.	 	1999 Agreement shall mean the memorandum of agreement executed by the Parties on July
13, 1999.
	 
	1.3.	 	IL-13 Agreement shall mean this Agreement, including all its Attachments.
	 
	1.4.	 	2001 Agreement shall mean the memorandum of agreement executed by the Parties on July
20, 2001.
	 
	1.5.	 	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.
	 
	1.6.	 	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.
	 
	1.7.	 	Reference MA shall mean any MA granted :

	 	–	 	for the territory of the United States of America ; or
	 
	 	–	 	for the territory of Japan ; or
	 
	 	–	 	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.

	1.8.	 	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.
	 
	1.9.	 	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.
	 
	1.10.	 	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.
	 
	1.11.	 	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 [...***...].
	 
	1.12.	 	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 [...***...].
	 
	1.13.	 	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.
	 
	1.14.	 	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

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

4

 

	 	 	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.
	 
	1.15.	 	Executive Committee shall mean the executive committee referred to in Article
4.1(a) of the 2001 Agreement.
	 
	1.16.	 	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.
	 
	1.17.	 	Not applicable
	 
	1.18.	 	Effective Date shall mean the date the 2001 Agreement takes effect.
	 
	1.19.	 	Implementation Date shall mean January 7, 2000.
	 
	1.20.	 	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.
	 
	1.21.	 	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.
	 
	1.22.	 	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.
	 
	1.23.	 	Exercise of Option 1 shall mean the occurrence of one of the events referred to in
Article 6.2.2.
	 
	1.24.	 	Exercise of Option 2 shall mean the obtaining of a Reference MA.
	 
	1.25.	 	IL-13 shall mean the protein with human cytokinic activity, cloned and discovered by
SANOFI-SYNTHELABO as more precisely described in Annex 1.25.
	 
	1.26.	 	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.
	 
	1.27.	 	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.
	 
	1.28.	 	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.
	 
	1.29.	 	Exclusive License Option shall mean the irrevocable option enjoyed by
SANOFI-SYNTHELABO pursuant to Article VI of the 2001 Agreement.
	 
	1.30	 	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.
	 
	1.31.	 	Parties shall mean SANOFI-SYNTHELABO and IDM collectively (each of the Parties being
individually designated as a “Party”).
	 
	1.32.	 	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.
	 
	1.33.	 	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.
	 
	1.34.	 	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.
	 
	1.35.	 	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.
	 
	1.36.	 	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.
	 
	1.37.	 	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 .
	 
	1.38.	 	Territory shall mean the entire world.
	 
	1.39.	 	Third Party shall mean any individual or any legal entity except the Parties and
their Affiliates.

ARTICLE 2 — PURPOSE

The purpose of this IL-13 Agreement is:

	 	(a)	 	to amend the conditions under which IDM will be supplied with IL-13;
	 
	 	(b)	 	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.

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.

ARTICLE 3 — IL-13 SUPPLY

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.

ARTICLE 6 —IL-13 LICENSE

	6.1.	 	Marketing of IL-13 Research Kits
	 
	 	 	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.
	 
	 	 	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.
	 
	 	 	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

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

8

 

	 	 	Research Kits sales made during the corresponding six calendar months that makes
it possible to identify the amounts payable.
	 
	 	 	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.
	 
	6.2.	 	Implementation of IL-13 Development Programs — Exercise of BSA 1 warrants
	 
	6.2.1.	 	Phase I and II studies
	 
	 	 	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.
	 
	 	 	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.
	 
	6.2.2.	 	Exercise of the BSA 1 warrants
	 
	 	 	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:
	 
	 	 	Events:

	 	(a)	 	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

	 	(b)	 	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.

	 	 	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
	 
	 	 	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.
	 
	6.2.3.	 	Phase III Studies

Except for SANOFI-SYNTHELABO IL-13 Development Programs that are
governed by the 2001 Agreement:

	 	–	 	IDM agrees to carry out at its sole expense Phase III Studies of IL-13
Development Programs and to use its best efforts to complete such Phase III Studies at
the earliest possible time compatible with applicable legal and regulatory
requirements.
	 
	 	–	 	IDM shall provide SANOFI-SYNTHELABO with semi-annual progress reports on
Phase III Studies and shall keep SANOFI-SYNTHELABO informed as soon as possible about
any problem that could have a significant negative effect on said Phase III Studies.

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	 	–	 	Representatives of IDM and SANOFI-SYNTHELABO shall meet, at the request of
either Party, to discuss the contents of semi-annual progress reports on Phase III
Studies as provided by IDM. During these meetings, IDM will provide any supplementary
information that SANOFI-SYNTHELABO might reasonably request about the results of Phase
III Studies, to the extent this additional information is available on the date of the
request by SANOFI-SYNTHELABO, and does not require any additional research or
investigations beyond those conducted by IDM.
	 
	 	–	 	IDM will provide SANOFI-SYNTHELABO with a summary report on Phase III Studies
carried out on one or more of the IL-13 Products within sixty (60) days following the
completion of these Phase III Studies.

	6.3.	 	Marketing of Final IL-13 Products — Exercise of BSA 2 warrants
	 
	6.3.1.	 	IDM’s decision to market Final IL-13 Products
	 
	 	 	Except for SANOFI-SYNTHELABO IL-13 Development Programs that are governed by article V of
the 2001 Agreement :

	 	(a)	 	IDM shall notify SANOFI-SYNTHELABO of its decision to market a
Final IL-13 Product by registered mail with return receipt sent within six (6)
months following completion of the Phase III Studies on the corresponding IL-13
Product;
	 
	 	(b)	 	IDM agrees to file MA applications as soon as possible for the corresponding
IL-13 Product.

	6.3.2.	 	Exercise of BSA 2 warrants
	 
	 	 	The obtaining by SANOFI-SYNTHELABO, within the context of a SANOFI-SYNTHELABO IL-13
Development Program governed by the 2001 Agreement, or by IDM under Article 6.3.1(b) above,
of a Reference MA shall be deemed as equivalent to the Exercise of Option 2 as specified in
the terms and conditions for the exercise of the BSA 2 warrants described in Annex 7.
Within thirty (30) days following the obtaining of such Reference MA, the Parties agree to
conclude an Amendment to the IL-13 License Agreement pursuant to the model set forth in
Annex 6.3.2 defining the conditions under which IDM can use and exploit the IL-13
Intellectual Property to market any Final IL-13 Product and (ii) the terms and conditions
of payment for the IL-13 Intellectual Property license thus granted by SANOFI-SYNTHELABO.

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	 	 	On the date of execution of the Amendment to the IL-13 License Agreement, SANOFI-SYNTHELABO
shall submit an invoice to IDM for the amount specified in Article 4.1.2. of the IL-13
License Agreement as amended by the Amendment to the IL-13 License Agreement, plus any
applicable amount for value-added taxes, in addition to a simplified subscription form
requesting exercise of the BSA 2 warrants.
	 
	 	 	Within thirty (30) days following the signature of the Amendment to the IL-13 License
Agreement, IDM shall cause its Board of Directors to draw up a statement of account,
certified by its auditors, and the Board of Directors shall acknowledge issuance of the shares resulting from the exercise of the BSA 2 warrants.

ARTICLE 7 — OFFSET

By express agreement between the Parties, all amounts payable to SANOFI-SYNTHELABO by IDM under the
IL-13 License Agreement and the Amendment of the IL-13 License Agreement, shall be owed by IDM only
provided the latter can pay by offset against any amount owed to it by SANOFI-SYNTHELABO for the
payment in full of the shares subscribed through the exercise of BSA 1 and/or BSA 2 warrants.

Lack of exercise of BSA1 and/or BSA2 warrants at the latest on their exercise date as indicated in
the early exercise provisions in Annex 7, shall be deemed equivalent to SANOFI-SYNTHELABO
renouncing to request any payment by IDM of any of the fixed amounts indicated in such articles.

ARTICLE 8 — EARLY EXERCISE OF BSA 1 AND BSA 2 WARRANTS

In the event of a transfer by IDM of all its assets to an authorized Third Party transferee, on the
terms and conditions specified in Article 15.2(c), or in the event of a change of control of IDM,
Option 1 and/or Option 2 shall be deemed exercised in advance, even though conditions for the
exercise of these Options have not been met, through application of the following provisions :

	8.1.	 	Transfer by IDM of all its assets to a Third Party transferee.
	 
	 	 	Transfer to a Third Party transferee shall be deemed equivalent to the Exercise of Option 1
and/or Option 2.
	 
	8.2.	 	Change of control of IDM
	 
	 	 	In the event IDM shares are traded on a regulated market, SANOFI-SYNTHELABO shall notify
IDM within fifteen (15) days following the

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	 	 	official filing of the operation likely to entail a Change of Control of IDM of its
decision to proceed with an early exercise its BSA 1 and/or BSA 2 warrants.
	 
	 	 	In the event IDM shares are not traded on a regulated market, SANOFI-SYNTHELABO shall
notify IDM of its decision to exercise its BSA 1 and/or BSA 2 warrants no more than ten
(10) days prior to implementation of the Change of Control of IDM, of which
SANOFI-SYNTHELABO shall have been notified, either by application of the IDM shareholders’
agreement or by prior notification by IDM sent to SANOFI-SYNTHELABO at least twenty (20)
days prior to the implementation of the Change of Control of IDM, in the event the IDM
shareholders’ agreement is null and void.
	 
	 	 	Receipt by IDM of the notice of early exercise by SANOFI-SYNTHELABO of its BSA 1 and/or BSA
2 warrants shall be deemed equivalent to the Exercise of Option 1 and/or of Option 2.
	 
	 	 	In the event of a decision by SANOFI-SYNTHELABO not to exercise its BSA 1 and/or BSA 2
warrants early, or absent a reply from SANOFI-SYNTHELABO within fifteen (15) days of ten
(10) days as specified above, the provisions of this IL-13 Agreement shall continue to
apply between the Parties.
	 
	8.3.	 	Exercise of BSA 1 and/or BSA 2 warrants
	 
	 	 	In the instances specified in Articles 8.1 and 8.2 above, exercise of BSA 1 and/or BSA
2 warrants shall occur on the date of the Transfer to the Third-Party transferee in the
case covered by Article 8.1 and, in the case covered by Article 8.2, on the date set by IDM
within a period of seven (7) days following the date of receipt by IDM of the notice
specified in Article 8.2.
	 
	 	 	On the date of exercise of the BSA 1 and/or BSA 2 warrants:

	 	–	 	the Parties shall enter into the IL-13 License Agreement
and/or the Amendment to the IL-13 License Agreement;
	 
	 	–	 	SANOFI-SYNTHELABO shall submit an invoice to IDM for the
amount of the fixed compensation specified in Article 4.1.1 of the IL-13
License Agreement and/or the fixed compensation specified in Article 4.1.2 of
the IL-13 License Agreement as amended by the Amendment to the IL-13 License
Agreement, as well as a simplified subscription form requesting the exercise
of BSA 1 and/or BSA 2 warrants;
	 
	 	–	 	IDM shall hold a meeting of the Board of Directors to draw up
a 

13

 

	 	 	 	statement of account certified by its internal auditors, and the Board of
Directors shall acknowledge issuance of the shares resulting from the exercise
of BSA 1 and BSA 2 warrants.

ARTICLE 9 — RESPONSIBILITY — INSURANCE 

	9.1.	 	Without prejudice to the provisions of common law, IDM alone shall assume any responsibility
that might arise from the implementation of IL-13 Development Programs, as well as from the
exploitation of the results, vis-à-vis any Third Party and on any basis whatsoever, including
on the basis of civil liability, in particular with respect to any damage that might result
from the use (in carrying out the Phase I and II Studies) of IL-13 supplied by
SANOFI-SYNTHELABO and not manufactured in accordance with “Good Manufacturing Practices”.
	 
	 	 	IDM alone shall also assume any liability that might arise (i) from any fault committed by
it or by any IDM Affiliate or sub-licensee within the context of the implementation of this
IL-13 Agreement, as well as (ii) for any failure on its part or on the part of any IDM
Affiliate or sub-licensee to perform its obligations pursuant to said IL-13 Agreement.
	 
	 	 	IDM shall also hold SANOFI-SYNTHELABO harmless with regard to any harmful consequences that
might arise for SANOFI-SYNTHELABO from any action brought against SANOFI-SYNTHELABO by a
Third Party based on damage of any kind whatsoever resulting from the circumstances
indicated above.
	 
	 	 	IDM warrants that it has taken out, at its sole expense, the necessary insurance coverage
on terms and conditions consistent with the practices in the pharmaceutical industry, in
order to sufficiently cover any risks that might result from the implementation of the
IL-13 Development Programs and/or the marketing of the IL-13 Research Kits and/or the Final
IL-13 Products. It shall provide evidence of such coverage at the request of
SANOFI-SYNTHELABO.
	 
	9.2.	 	Without prejudice to the provisions of common law, SANOFI-SYNTHELABO alone shall assume the
liability that could result (i) from any fault committed by it or by any SANOFI-SYNTHELABO
Affiliate or sub-licensee within the context of the implementation of this IL-13 Agreement,
(ii) from any failure by it or by any SANOFI-SYNTHELABO Affiliate or sub-licensee to meet its
obligations under said Agreement, as well as (iii) from its supply to IDM of IL-13 that is not
up to contractual specifications.

14

 

	 	 	Consequently, it guarantees IDM against all prejudicial consequences that might arise for
IDM from an action brought against it by a Third Party based on damage of any kind
whatsoever resulting from the circumstances identified above.
	 
	 	 	SANOFI-SYNTHELABO guarantees that it has taken out the necessary insurance at its sole
expense, on terms and conditions consistent with the practices of the pharmaceutical
industry, in order to provide sufficient coverage of the risks likely to arise from the
quantities of supplied IL-13.
	 
	9.3.	 	The above provisions do not apply to SANOFI-SYNTHELABO IL-13 Development Programs, which are
governed by the 2001 Agreement.

ARTICLE 10 — SANOFI-SYNTHELABO GUARANTEES

SANOFI-SYNTHELABO guarantees to IDM the existence of the IL-13 Patents and IL-13 Knowhow and the
accuracy of its facts. In addition, SANOFI-SYNTHELABO declares that it is sole owner of the IL-13
Patents and IL-13 Knowhow and guarantees that it can freely and validly grant the rights to said
IL-13 Patents and IL-13 Knowhow that it is granting under this IL-13 Agreement, the Contributions
Agreement, the IL-13 License Agreement and the Amendment to the IL-13 License Agreement. The above
guarantees are made subject to the statements included in Annex 10, in particular as regards the
existence on the territory of the United States of patents filed by [...***...] SANOFI-SYNTHELABO
agrees to keep the IL-13 Patents in force in accordance with applicable legal and regulatory
provisions, in particular by carrying out, at the appropriate time, necessary procedures and
formalities, provided that, in the event of an extension of the IL-13 Patents or corresponding
supplementary protection certificates, IDM has provided it with all necessary documents and
signatures, when the MA of the Final IL-13 Product is not in the name of SANOFI-SYNTHELABO. All
costs pertaining thereto shall be paid by SANOFI-SYNTHELABO.

ARTICLE 11 — IMPROVEMENTS MADE OR ACQUIRED BY SANOFI-SYNTHELABO 

	11.1.	 	SANOFI-SYNTHELABO shall retain sole and full title to all Improvements that it makes or
acquires.
	 
	 	 	In order to allow IDM to have IL-13 manufactured, SANOFI-SYNTHELABO shall transmit to
IDM free of charge and as soon as possible any improvement related to the manufacturing and
production processes and/or methods for IL-13 and IL-13 made pursuant to “Good

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

15

 

	 	 	Manufacturing Practices” that it may have at its disposal during the life of this
IL-13 Agreement in a physically transmissible form, and to which it shall have unencumbered
access.
	 
	 	 	As regards Improvements other than those specified in the preceding paragraph, in the event
SANOFI-SYNTHELABO wishes to make these Improvements available to any Third Party, it
irrevocably agrees to offer them to IDM on conditions, especially financial conditions, at
least equal to the most favorable conditions offered to any Third Party, during the life of
this IL-13 Agreement, of the IL-13 License Agreement and of the Amendment to the IL-13
License Agreement.
	 
	11.2.	 	Use of the IL-13 Intellectual Property specified in the Contributions Agreement and all
rights granted by SANOFI-SYNTHELABO to IDM under this IL-13 Agreement, the IL-13 License
Agreement and the Amendment to the IL-13 License Agreement shall fully extend to Improvements
transmitted pursuant to the provisions of Article 11.1 above, as soon as they are known, and
SANOFI-SYNTHELABO shall, on its own initiative and at its own expense, carry out all necessary
formalities and procedures to guarantee the effective implementation of this provision. IDM
agrees to participate, if necessary, in this protection and, in particular, to sign all
necessary acts and documents.
	 
	11.3.	 	Subject to the provisions of Article 11.1, it is expressly agreed by the Parties that the
transfer of Improvements by SANOFI-SYNTHELABO shall not entail any change to the financial
terms and conditions of the Contributions Agreement, the IL-13 License Agreement and the
Amendment to the IL-13 License Agreement.

ARTICLE 12 — IMPROVEMENTS MADE OR ACQUIRED BY IDM

	12.1.	 	IDM shall retain sole and full title to all results, tangible or intangible, patentable
or non-patentable, patented or not patented, arising from the IL-13 Development Programs or
from any improvements to its own patents that it may make or acquire.
	 
	 	 	SANOFI-SYNTHELABO unconditionally and irrevocably agrees not to claim any right
whatsoever to IDM’s research or inventions.
	 
	 	 	It shall be the responsibility of IDM, if it so wishes, to carry out at its own expense
all necessary formalities and steps to ensure the protection of its rights under
applicable statutes, and SANOFI-SYNTHELABO agrees to participate if necessary in this
protection and, in particular, to sign all necessary acts and documents.

16

 

	12.2.	 	The above provisions apply subject to any conflicting provisions of the 2001 Agreement.

ARTICLE 13 — TERRITORY

Rights granted by SANOFI-SYNTHELABO to IDM under this IL-13 Agreement are granted for the
Territory.

ARTICLE 14 — TERM — CANCELLATION 

	14.1.	 	This IL-13 Agreement shall take effect on the Effective Date. It shall be automatically
cancelled in the event one of the Parties cancels the 2001 Agreement in application of Article
10.2 of that Agreement, in which case the 1999 Agreement shall automatically resume all its
effects.
	 
	14.2.	 	This IL-13 Agreement shall remain in effect for a period equal to that of the legal
protection attached to the IL-13 Patents. The effect of this IL-13 Agreement shall cease, in
each of the countries involved, on the expiration date of the last IL-13 Patent relative to
that country.
	 
	14.3.	 	SANOFI-SYNTHELABO may cancel this IL-13 Agreement pursuant to a simple notice by registered
mail with return receipt given sixty (60) days in advance, in the following cases:

	 	(a)	 	Option 1 has not been validly exercised no later than five (5) years
following the Implementation Date;
	 
	 	(b)	 	or, after Option 1 has been exercised, Option 2 is not validly exercised no
later than ten (10) years from the Implementation Date;
	 
	 	(c)	 	on the expiration date of a period of five (5) years calculated as of the
filing of the first application for a Reference MA, if by that date such MA has not
been obtained.

	14.4.	 	This IL-13 Agreement may also be cancelled by IDM in the event of non-exercise of Option 1
or Option 2 for any IL-13 Development Program, subject to a prior notice of sixty (60) days
from the expiration date of each of the notification deadlines defined in Articles 6.2.2(b)
and 6.3.1(a) above, respectively.
	 
	14.5.	 	In the event of cancellation, all quantities of IL-13 held by IDM on the cancellation date,
to the extent these quantities correspond to those contributed to IDM under the Contributions
Agreement, as well as all documents of any kind provided by SANOFI-SYNTHELABO to IDM

17

 

	 	 	pursuant to the provisions of the 1999 Agreement, the Contributions Agreement, this IL-13
Agreement or the IL-13 License Agreement, shall be returned by IDM to SANOFI-SYNTHELABO not
later than by the expiration date of the notice of cancellation, without any economic
consideration payable by SANOFI-SYNTHELABO.
	 
	14.6.	 	This IL-13 Agreement may not be cancelled by SANOFI-SYNTHELABO in application of Article
14.3 or by IDM in application of Article 14.4 as long as a SANOFI-SYNTHELABO IL-13 Development
Program is in effect.

ARTICLE 15 — ASSIGNMENT OF THE IL-13 AGREEMENT 

	15.1.	 	Assignment of the IL-13 Agreement by SANOFI-SYNTHELABO 
	 
	 	 	SANOFI-SYNTHELABO shall have the right to freely transfer the rights arising globally
from the IL-13 Patents, IL-13 Knowhow, this IL-13 Agreement, the Contributions
Agreement, the IL-13 License Agreement and the Amendment to the IL-13 License Agreement
(in any form whatsoever, and specifically in the form of assignment, contribution,
exchange, merger, etc.) and shall be released from any obligation under said agreements
as of the date of their transfer.
	 
	 	 	In the event of the isolated transfer of these agreements, SANOFI-SYNTHELABO agrees to
advise IDM of such a transfer not less than fifteen (15) days prior to the date set for
such transfer, subject to any legal, regulation or contractual non-disclosure obligation
regarding this information that is incumbent upon SANOFI-SYNTHELABO.
	 
	 	 	In the event of the transfer of this package as part of a transfer by SANOFI-SYNTHELABO
of all or part of its activities, SANOFI-SYNTHELABO agrees to advise IDM of such
transfer not less than fifteen (15) days prior to the date of such transfer, subject to
any legal, regulatory or contractual non-disclosure obligation regarding this
information that is incumbent upon SANOFI-SYNTHELABO.
	 
	 	 	In both hypotheses contemplated above, the agreement implementing the transfer shall
expressly indicate that the beneficiary of the transfer shall be bound by all
obligations incumbent upon SANOFI-SYNTHELABO under the IL-13 Agreement, the
Contributions Agreement, the IL-13 License Agreement and the Amendment to the IL-13
License Agreement.
	 
	 	 	
In the event the above-referenced transfer is made to a SANOFI-SYNTHELABO Affiliate,
SANOFI-SYNTHELABO agrees (i) jointly with the Affiliate that the latter shall fulfill
the obligations incumbent upon the Affiliate under the IL-13 Agreement, the
Contributions Agreement, the

18

 

	 	 	IL-13 License Agreement and the Amendment to the IL-13 License Agreement and (ii) in the
event the transferee subsequently ceases to be one of its Affiliates, to cause the
rights and obligations to be re-transferred ahead of time to itself or to another
Affiliate.
	 
	15.2.	 	Assignment of the IL-13 Agreement by IDM 
	 
	 	 	IDM recognizes that its rights under this IL-13 Agreement, the Contributions Agreement,
the IL-13 License Agreement and the Amendment to the IL-13 License Agreement, are strictly
personal. On that basis, and subject to the provisions set forth below, IDM agrees not to
assign, transfer or convey its rights to anyone, whether directly or indirectly, in whole
or in part, against payment or free of charge, without prior written authorization from
SANOFI-SYNTHELABO. IDM further agrees not to confer to any Third Party any right of any
kind whatsoever on the Contributions.
	 
	 	 	By way of exception to the above provisions, IDM may:

	 	(a)	 	assign, transfer or transmit its rights and obligations arising from this
IL-13 Agreement, the Contributions Agreement, the IL-13 License Agreement and the
Amendment to the IL-13 License Agreement to any of its Affiliates, subject to the
following cumulative conditions: (i) that IDM agrees, in the event the transferee
were subsequently to cease to be an IDM Affiliate, to cause the rights and
obligations to be first re-transferred to IDM or to any other IDM Affiliate, (ii)
that IDM shall be the joint guarantor that this Affiliate shall respect these rights
and obligations and (iii) that IDM shall reiterate the commitments made to
SANOFI-SYNTHELABO in Article 4.1.2. of the IL-13 License Agreement or Article 4.1.3.
of the IL-13 License Agreement, in the event the assignment of IDM’s rights were to
take place while BSA 1 and/or BSA 2 warrants cannot as yet be exercised.
	 
	 	(b)	 	transfer its rights and obligations under this IL-13 Agreement, the
Contributions Agreement, the IL-13 License Agreement and the Amendment to the IL-13
License Agreement following a takeover of IDM by another company or the dissolution
of IDM through a merger of capital assets and holdings pursuant to the provisions of
Article 1844-5 of the French Civil Code.
	 
	 	(c)	 	Transfer its rights and obligations under this IL-13 Agreement, the
Contributions Agreement, the IL-13 License Agreement and the Amendment to the IL-13
License Agreement as a result of the assignment or contribution of all its activities
to an entity other than an Affiliate.

19

 

ARTICLE 16 — DEFENSE OF THE IL-13 INTELLECTUAL PROPERTY

SANOFI-SYNTHELABO shall have the obligation, at its sole expense:

	 	(a)	 	to defend in all circumstances the IL-13 Intellectual Property covered by this
Agreement, specifically by carrying out, both as plaintiff and as respondent, both in
France and abroad, all actions permissible under the law for the holder of the IL-13
Intellectual Property;
	 
	 	(b)	 	to inform IDM as soon as possible of all actions (in which it is the plaintiff or
the respondent), both current or planned, as well as of any threat in fact or by law to
the IL-13 Intellectual Property which it might have knowledge of and which could have a
significant effect on the exploitation of the IL-13 Intellectual Property;
	 
	 	(c)	 	not to create any obstacle in fact or by law to the potential intervention
of IDM in a given proceeding, provided that this intervention does not potentially harm significantly SANOFI-SYNTHELABO’s interests.

IDM shall have the obligation of informing SANOFI-SYNTHELABO, at its sole expense, of any
infringement by Third Parties of the rights to the IL-13 Intellectual Property of which it
might have knowledge.

The Parties, recognizing that certain bodies of law, including French law, do not permit the
non-exclusive holder of intellectual rights to act alone in any legal proceedings, consider
as essential the obligation imposed on SANOFI-SYNTHELABO under this Article 16.

SANOFI-SYNTHELABO is bound by the obligation arising from this Article 16 only provided the
costs incurred by it for compliance remain reasonable in terms of the stakes and
probabilities of success of the actions undertaken. Consequently, if these costs seem
unreasonable to SANOFI-SYNTHELABO, it is understood that the Parties shall get together in
order to examine, in good faith, any alternative solution that could be suitable to the
objectives sought by each of the Parties.

ARTICLE 17 — CONFIDENTIALITY

	17.1.	 	The confidentiality agreement executed on May 23, 1997 remains in effect as to all
provisions not contrary to the stipulations of this IL-13 Agreement and shall continue, by
express agreement of the Parties, to be incumbent upon them for the entire life of this
IL-13 Agreement and for a period of ten (10) years following its expiration.

20

 

	17.2.	 	Absent any legal, regulatory or judicial constraint, each Party agrees not to disclose
this IL-13 Agreement and/or its annexes, to engage in any publicity and/or to issue any
press release as to the execution and the content of this IL-13 Agreement without prior
authorization of the other Party, which authorization may not be refused without just
cause. In no event may the provisions of this IL-13 Agreement be construed as prohibiting
IDM from providing information on the results relative to IL-13 Development Programs.

ARTICLE 18 — ANNEXES

The following Annexes to this IL-13 Agreement cannot be separated from such IL-13 Agreement, of
which they are an integral part.

However, in case of conflict, the stipulations of this IL-13 Agreement shall prevail over the
stipulations of the Annexes, and in particular, in the case of the IL-13 License Agreement and
the Amendment to the IL-13 License Agreement.

ARTICLE 19 — SAFEGUARD CLAUSE

In view of the complexity of the operations proposed by the Parties under this IL-13 Agreement
and the 2001 Agreement and their Annexes, the Parties recognize that they cannot reasonably
anticipate all difficulties that may arise from their execution.

In the event such difficulties were to arise, the Parties agree to negotiate in good faith all
supplements and/or changes to this IL-13 Agreement or its Annexes that would make it possible to
resolve their difficulties in a manner consistent with the common intent of the Parties.

ARTICLE 20 — NOTICES

All notices under this IL-13 Agreement shall be given by registered mail with return receipt to the
addresses indicated in the header or to any other address that may be made known in advance to one
or other Party.

ARTICLE 21 — APPLICABLE LAW — DISPUTES

This IL-13 Agreement is governed by French law, provided, however, that this cannot be an obstacle
to the application in each State of the provisions of local law that might grant longer, more
extensive or more vigorous protection for the IL-13 Patents and/or to the IL-13 Knowhow.

21

 

Any differences arising from this IL-13 Agreement or in connection with it shall be permanently
resolved in accordance with the Rules of Arbitration of the International Chamber of Commerce, by
one or more arbitrators named pursuant to these Rules. The place of arbitration shall be Paris and
the language of arbitration shall be French.

ARTICLE 22 — POWER OF ATTORNEY

Power of attorney is given to the bearer of a copy or excerpt of this agreement in order to
carry out all formalities, and in particular in order to cause this agreement to be filed with
the National offices of the relevant countries.

ARTICLE 23 — NOTIFICATION OF THE IL-13 AGREEMENT — REGISTRATION

Notice of the IL-13 License Agreement and the Amendment to the IL-13 License Agreement shall be
given by IDM to the Bureau of Transfers of the National Institute of Industrial Property (Institut
National de la Propriété Industrielle) and/or listed with the relevant foreign Industrial Property
offices, and the Parties agree here and now to sign all documents, power-of-attorney and other
powers necessary to the implementation and registration of the IL-13 License Agreement and/or of
the Amendment to the IL-13 License Agreement in order to make them opposable to Third Parties in
all countries.

In the event this IL-13 Agreement is registered, all costs and fees relative to such formality
shall be paid by IDM.

Executed in Paris on November 30, 2001, in two (2) originals.

	 	 	 	 	 	 	 	 	 
	IDM	 	 	 	SANOFI-SYNTHELABO
	 
	 	 	 	 	 	 	 	 
	/s/ Jean-Loup Romet-Lemonne	 	 	 	/s/ Jean-Claude Leroy
	 	 	 	 	 
	By:

	 	Jean-Loup Romet-Lemonne
	 	 	 	By:
	 	Jean-Claude Leroy
	 

	 	President
	 	 	 	 	 	Senior Vice President, Strategy
and Business Development
	 
	 	 	 	 	 	 	 	 
	/s/ Bernard Brigonnet	 	 	 	/s/ José Ferrer
	 	 	 	 	 
	By:

	 	Bernard Brigonnet
	 	 	 	By:
	 	José Ferrer
	 

	 	Managing Director
	 	 	 	 	 	Director Legal Affairs Operations

22

 

LIST OF ANNEXES

	 	 	 
	ANNEX 1.10. :

	 	Detailed description of the IL-13 patents
	 
	 	 
	ANNEX 1.13. :

	 	List of IDM shareholders as at the 1999 signature date
	 
	 	 
	ANNEX 1.25. :

	 	IL-13 detailed description.
	 
	 	 
	ANNEX 1.35. : 

	 	List of il-13 development programs in effect as of the execution date of the IL-13 agreement.
	 
	 	 
	ANNEX 6.2.2. :

	 	IL-13 License Agreement
	 
	 	 
	ANNEX 6.3.2. :

	 	Amendment No. 1 to IL-13 License Agreement
	 
	 	 
	ANNEX 7. :

	 	Exercise conditions for BSA1 and BSA 2 warrants 
	 
	 	 
	ANNEX 10. :

	 	Reservations relative to the guarantees on the IL-13 intellectual property

23

 

ANNEX 1.10 :

Detailed description of ii-13 patents

[...***...]

[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

24

 

[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80 (b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

25

 

ANNEX 1.13. :

list of idm shareholders as at the signature date of the 1999 agreement

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80 (b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

26

 

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80 (b) (4) and 
	 

	 	 	 	240.24b-2(b)(1)

27

 

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

28

 

[...***...]

[...***...]

[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

29

 

ANNEX 1.25. :

IL-13 detailed description 

IL-13 is the exclusive designation of [...***...].

IL-13 also designates all [...***...].

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

30

 

ANNEX 1.35. :

List of IL-13 Development Programs in effect on the execution date of the IL-13

Agreement

[...***...]

	 	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

31

 

	 	 	 
	          [...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	          [...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]

[...***...]

[...***...]

	 	 	 
	[...***...]
	 	 
	[...***...]
	 	 
	[...***...]
	 	 
	 
	 	 
	[...***...]
	 	 
	 
	 	 
	[...***...]
	 	 
	 
	 	 
	          [...***...]
	 	 
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]
	 
	 	 
	          [...***...]
	 	 
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]
	 

	 	     [...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

32

 

	 	 	 
	     [...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

33

 

	 	 	 
	                    [...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	          [...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	[...***...]
	 	 
	 
	 	 
	          [...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 
	 	 
	          [...***...]
	 	 
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]
	 

	 	[...***...]

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

34

 

ANNEX 6.2.2 :

IL-13 Intellectual Property License Agreement

[Obsolete — replaced by the Amended and Restated IL-13 license agreement entered into on

August 12, 2005 following early exercise by Sanofi-Aventis of its BSA1 and BSA2 warrants]

35

 

Annex 6.3.2.:

Amendment 1 to the IL-13 Intellectual Property License Agreement

[Obsolete — replaced by the Amended and Restated IL-13 license agreement entered into on

August 12, 2005 following early exercise by Sanofi-Aventis of its BSA1 and BSA2 warrants]

36

 

Annex 7. :

Terms and Conditions for the exercise of the BSA 1 and BSA 2 warrants

[Obsolete since BSA1 and BSA2 warrants have been exercised]

37

 

Annex 10 :

Reservations relative to the guarantees on the IL-13 Intellectual Property

The Parties recognize that IDM carried out, prior to signing the 1999 Agreement, an audit of the
IL-13 Intellectual Property rights.

This audit was conducted through [...***...], which prepared a specific report dated April 28, 1999
(herienafter, the « Report ») sent to IDM and a copy of which was transmitted to SANOFI-SYNTHELABO.

The Report is deemed to be an integral part of this IL-13 Agreement.

It is understood by the Parties that the guarantees defined in Article 10 of this IL-13 Agreement
are extended subject to the items set forth in the Report, in particular as regards the [...***...]
patents referred to therein.

More generally, it is understood that in no event may IDM hold SANOFI-

SYNTHELABO liable, on any basis whatsoever, for facts as to which SANOFI-SYNTHELABO can demonstrate
that IDM had knowledge on the date of signature of the 1999 Agreement, either as a result of the
completion of the above-mentioned audit, or by any other way.

	 	 	 	 	 
	 

	 	*
	 	Confidential
Treatment Requested 

under 17 C.F.R. §§ 200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

38Exhibit 10.57

 

EXHIBIT 10.57

***Text Omitted and Filed Separately
Confidential Treatment
Requested
Under 17 C.F.R. §§ 200.80(b)(4)
and
240.24b-2(b)(1)

Development Collaboration and Supply Agreement

between 

Medarex, Inc.
 

and 

IDM S.A.

 

 

DEVELOPMENT COLLABORATION AND SUPPLY AGREEMENT

     This Development Collaboration and Supply Agreement (the “Agreement”) is made and
entered into as of May 24, 2002 (the “Effective Date”), by and between Medarex, Inc., a
New Jersey corporation, with its principal place of business at 707 State Road #206, Princeton,
New Jersey 08540, (“Medarex”), and IDM S.A., a French corporation with its principal place of
business at 172 rue de Charonne, 75011 Paris, France (“IDM”).

RECITALS

     Whereas, IDM is a company that develops and commercializes cellular therapy
products;

     Whereas, Medarex owns intellectual property rights relating to the anti-CTLA-4
antibody, and operates an antibody manufacturing facility;

     Whereas, IDM and Medarex signed a Letter of Intent dated January 17, 2000 in which
Medarex has agreed to grant to IDM certain rights to the anti-CTLA-4 antibody for use in cellular
therapy applications;

     Whereas, IDM and Medarex executed an Amended and Restated Technology Access
Agreement dated July 21, 2000 (as amended, the “Technology Access Agreement”) in which IDM has
agreed to fund a research and development program at Medarex in the amount of [...***...];

     Whereas, IDM and Medarex have agreed that IDM may meet its commitment for funding
the above-mentioned research and development program by spending a portion of the [...***...] on
certain internal research programs related to antibodies received from Medarex;

     Whereas, IDM and Medarex have agreed to restructure their relationship with respect
to the anti-CTLA-4 antibody and the research and development program to be funded by IDM;

     Whereas, under the restructured relationship, IDM now wishes to purchase, and Medarex
now wishes to supply anti-CTLA-4 antibodies for use in the development of cellular therapy
products, and the parties agree that certain costs related to the development of cellular therapy
products using anti-CTLA-4 antibodies, and the supply price paid by IDM for the anti-CTLA-4
antibodies paid under this Agreement will be credited against the above mentioned [...***...];

     Now, Therefore, in consideration of the mutual promises and covenants set forth
below, IDM and Medarex mutually agree as follows:

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

2

 

1. Definitions

     Each of the capitalized terms used in this Agreement (other than the section headings),
whether used in the singular or the plural form, shall have the meaning as set forth below or, if
not listed below, the meaning as defined in places throughout this Agreement.

     1.1 “Affiliate” shall mean any Person that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with another Person. For
purposes of this definition only, “control” and, with correlative meanings, the terms “controlled
by” and “under common control with” shall mean (a) the possession, directly or indirectly, of the
power to direct the management or policies of a Person, whether through the ownership of voting
securities or by contract relating to voting rights or corporate governance, or (b) the ownership,
directly or indirectly, of at least fifty percent (50%) of the voting securities or other ownership
interest of a Person, or if lower, the maximum ownership percentage permitted by local law where
such local law restricts foreign ownership. For purposes of this definition only, “Person” shall
mean a partnership, limited partnership, limited liability partnership, corporation, limited
liability company, business trust, joint stock company, trust, unincorporated association, joint
venture or other similar entity or organization, including a government or political subdivision,
department or agency of a government. Notwithstanding the above, Medarex and IDM shall not be
deemed Affiliates of each other.

     1.2 “Antibody” shall mean the antibody identified as Anti-CTLA-4, as further described in the
Specifications, and any fragments or derivatives thereof, used for boosting immune response in
conjunction with the administration of the Cell-Based Vaccine. By way of clarification, references
in the Agreement to an “Antibody” shall not include (a) cells expressing or secreting such antibody
or containing nucleotide sequences (whether coding or non-coding) with respect lo the expression of
such Antibody, or (b) nucleotide sequences (whether coding or non-coding) with respect to the
expression of such Antibody or a fragment of such entire Antibody containing that portion of such
Antibody conferring binding specificity for an antigen.

     1.3 “Batch” shall mean a specific quantity of Antibody that is intended to have uniform
character and quality, within specified limits, and is produced according to a single manufacturing
order during the same cycle of manufacture.

     1.4 “BLA” shall mean a Biologics License Application as defined in the U.S. Food, Drug and
Cosmetics Act and the regulations promulgated thereunder, and any corresponding or equivalent
marketing authorization application registration or certification in countries other than the USA
(“MAA”).

     1.5 “Cell-based Vaccine” shall mean a product for the prevention of human diseases comprising
(a) IDM’s proprietary whole dendritic cells that have been modified through the selective
isolation, engineering, expansion or activation of specific cell populations performed in vitro,
(b) an antigen, (c) a vector for introducing the antigen into the cell, and possibly (d) a
maturation agent, (each a “Subcomponent”).

3

 

     1.6 “cGMP” shall mean current good manufacturing practices for medicinal products
established by regulations in the USA (including 21 CFR §§210 and 211, as amended, and any
successor regulations thereto).

     1.7 “Confidential Information” shall mean any Information, whether in oral, written,
graphic, electronic or tangible form, disclosed by one party to the other under this Agreement
and all pre-existing confidentiality and nondisclosure agreements between the parties relating
to the subject matter of this Agreement or obtained in the course of this Agreement.

     1.8 “Contract Year” shall mean the twelve (12) month period following the Effective Date
and any anniversary thereof.

     1.9 “DMF” shall mean a drug master file to be maintained with the FDA and the equivalent
thereof, as applicable, in jurisdictions outside the United States.

     1.10 “FDA”, shall mean United States Food and Drug Administration and any successor
agency thereto.

     1.11 “Field” shall mean the treatment and prevention of the human diseases listed in
Exhibit A (as may be amended from time to time by written agreement of the parties) using
Cell- based Vaccines.

     1.12 “IND” shall mean an Investigational New Drug Application filed with the FDA in
conformance with applicable laws and regulations, and the equivalent thereof, as applicable,
in jurisdictions outside the United States.

     1.13 * “Information” shall mean any information, either enabling or
disabling, including the terms of this Agreement, any information contained in any batch
record, purchase order, or databases, and any practices, methods, techniques,
specifications, formulations, formulae, knowledge, know-how, skill, experience, test data,
analytical and quality control data, stability data, studies and manufacturing procedures and
protocols, and any cost information related to the manufacture of Antibody.

     1.14 “Invention”, shall mean any invention or discovery, including any improvement,
alteration or enhancement of or modification to an existing invention or discovery, that is or
may be patentable.

     1.15 “Marketing Authorization Approval” shall mean, with respect to a particular country,
the approval by the Regulatory Authority of the BLA or MAA filed in such country for the
Product, Product Component, or Antibody.

     1.16 “Medarex Development Program” shall have the meaning as set forth in Section 2.1.

     1.17 “Net Revenues” shall mean the gross cash amount or the fair market value of stock
(“Consideration”) received by Medarex from a third party in connection with the grant of
rights or sublicenses to such third party pursuant to Section 7.4(b), less the following
deductions:

4

 

          (a) if the Consideration is received by Medarex in consideration of the supply of
Antibody, any amounts corresponding to Medarex’s cost of goods sold of the Antibody, determined by
Medarex in accordance, with US GAAP consistently applied, and any prompt payment or other customary
trade or quantity discounts actually allowed and taken, amounts repaid or credited by reason of
timely rejections or returns, taxes on the sale of a product (other than franchise or income taxes
on the income of the seller) actually paid or withheld, and transportation and delivery charges,
including transport insurance premiums, actually incurred;

          (b) any Consideration received as payment for the fair market value of any equity issued by
Medarex (as determined in good faith by the party issuing such equity);

          (c) any Consideration received as research and development funding; and

          (d) any Consideration received as a loan.

     1.18 “Product” shall mean any product for use in the Field that consists of two
contemporaneously administered components, with the first component being a Cell-based Vaccine and
the second component being the Antibody.

     1.19 “Product Component” shall mean the Cell-based Vaccine or the Antibody developed and
intended for use as components of a Product.

     1.20 “QC Sample” shall have the meaning as set forth in Section 5.2.

     1.21 “Regulatory Authorities” shall mean the FDA and any corresponding non-US health
regulatory authorities.

     1.22 “Serious Adverse Event/Experience” or “SAE” shall have the meaning promulgated by the
FDA, including but not limited to, any adverse experience occurring at any dose that results in
any of the following outcomes: death, a life-threatening adverse experience, inpatient
hospitalization or prolongation of existing hospitalization, a persistent or significant
disability/incapacity, or a congenital anomaly/birth defect. Important medical events that may not
result in death, be life-threatening, or require hospitalization may be considered a serious
adverse experience when, based upon appropriate medical judgment, they may jeopardize the patient
or subject and may require medical or surgical intervention to prevent one of the outcomes listed
in this definition. Examples of such medical events include allergic bronchospasm requiring
intensive treatment in an emergency room or at home, blood dyscrasias or convulsions that do not
result in inpatient hospitalization, or the development of drug dependency or drug abuse.

     1.23 “Sole Patent” means any patent or patent application owned or assigned solely to Medarex
or IDM, as applicable, during the term of this Agreement.

     1.24 “Specifications” shall mean the specifications of the Antibody contained in Exhibit B (as
amended from time to time by written agreement between the parties).

5

 

     1.25 “Sponsor” shall have the meaning defined by the International Conference on
Harmonisation: Good Clinical Practice: Consolidated Guideline (Federal Register Vol. 62, No. 90:
pp. 25691-25709).

     1.26 “Technology Access Agreement” shall have the meaning set forth in the recitals of this
Agreement.

2. Development Collaboration

     2.1 Scope of the Development Collaboration.

          (a) IDM and Medarex shall collaborate on the development of the Product, with Medarex having
primary responsibility for developing the commercial scale manufacturing process for the Antibody
for Phase III and commercial sale, and for any clinical trials prior to Phase III studies, if so
required by the FDA or any European or Japanese equivalent, and IDM having the primary
responsibility for conducting alone or with or through third parties the preclinical and the
clinical trials with the Product Components except the Antibody other than as part of the Product
(the “Product Development Program”) as further described in this Section 2. Notwithstanding the
above, if Japanese regulatory authorities have specific requirements regarding the manufacturing
process for the Antibody that Medarex has not already fulfilled, Medarex will not be required to
perform such process development as required by such Japanese regulatory authorities; provided that
Medarex will perform such process development if IDM agrees to fund such process development
program, and provided further, that if IDM funds such process development program, IDM shall not be
required to make the milestone payment set forth in Exhibit C upon MAA approval in Japan.

          (b) independent of the Product Development Program, Medarex shall have the right to conduct
development programs with the Antibody for any use and purpose (each such development program a
“Medarex Development Program”). Medarex may obtain Marketing Authorization Approval of the Antibody
separate from the Marketing Authorization Approval obtained for the Product. Medarex shall have
complete discretion as to the scope of such independent development of the Antibody and the
resources applied to such development, and may decide to discontinue any Medarex Development
Program at any time.

     2.2 Collaboration Governance.

          (a) Establishment of the Steering Committee. The parties shall establish a joint committee
(the “Steering Committee”), which shall oversee the Product Development Program. IDM and Medarex
shall each appoint two (2) representatives with the requisite experience and seniority to enable
them to make decisions on behalf of the parties with respect to the Product Development Program.
The Steering Committee meetings shall be held not less than twice a year. From time to time,
IDM and Medarex each may substitute any of its representatives to the Steering Committee.

          (b) Tasks of the Steering Committee. The Steering Committee shall: (i) prepare a plan and
budget for the Product Development Program (the “Product Development

6

 

Plan”); (ii) approve all protocols for clinical trials that are part of the Product
Development Program, and any changes to such protocols; (iii) review and monitor the progress of
the Product Development Program; (iv) discuss and approve any updates and amendments to the
Product Development Plan proposed by either of the parties; (v) coordinate and monitor
dissemination or publication of research results obtained from and the exchange of information and
materials that relate to the Product Development Program; and (vi) perform any other tasks
specifically assigned to it in this Agreement. The Steering Committee shall not have any power to
amend this Agreement and shall have only such powers as are specifically delegated to it
hereunder.

          (c) Procedures and Decisions of the Steering Committee. Except as explicitly set forth in
this subsection (c), the Steering Committee shall establish its own procedural rules for its
operation.

               (i) The Steering Committee shall take action by unanimous consent of IDM and Medarex, with
each such party having a single vote, irrespective of the number of representatives actually in
attendance at a meeting, or by a written resolution signed by the designated representatives of
each of IDM and Medarex.

               (ii) If the Steering Committee is unable to arrive at an unanimous consent regarding a matter
within its powers pursuant to subsection (b) above within twenty (20) days after one of the
parties requests a formal decision thereon, such matter shall be referred to the Chief Executive
Officers of each of the parties (or their respective designees) who shall use their good faith
efforts to mutually agree upon the proper course of action to resolve the matter.

               (iii) If the matter is not resolved by the Chief Executive Officers of the parties (or their
designees) within ten (10) business days after such matter is referred to them pursuant to the
preceding subsection (ii), then Medarex’s Chief Executive Officer or his designee shall have the
right to make the final decision with respect to matters relating to the Antibody (including, the
Product Development Program relating to the Antibody, the Specifications and the manufacturing
process for the Antibody), and IDM’s Chief Executive Officer shall have the right to make the
final decision with respect to matters relating to the Cell-based Vaccine (including the Product
Development Program relating to the Cell-based Vaccine). Notwithstanding the above, any decision
of Medarex’s Chief Executive Officer to discontinue the supply of Antibody to IDM for use in the
Product Development Program must be based on reasons other than mere commercial reasons, such as
safety, efficacy, or other extraordinary regulatory issues, including any such issues that may
adversely affect the development and commercialization of the Antibody developed by Medarex in a
Medarex Development Program.

     2.3 Process Development Program. Medarex shall use commercially reasonable efforts to develop
the manufacturing process for the Antibody for clinical trials and commercial sale meeting the
Specifications for manufacture of the Antibody for use in clinical trials. Notwithstanding anything
in this Agreement, Medarex may discontinue at any time and in its sole discretion all Medarex
Development Programs, and the development of a manufacturing process for the Antibody. Medarex
shall inform IDM promptly upon such discontinuation. IDM may request that Medarex continue with the
process development for the Antibody at IDM’s expense. If Medarex does not wish to undertake such
process development, Medarex shall at the request and expense of IDM, transfer the manufacturing
process for the Antibody as it exists at

7

 

that time to IDM or a third party manufacturer designated by IDM pursuant to a technology
transfer plan and budget agreed upon by the parties.

     2.4 Product Development Program.

     (a) IDM shall use commercially reasonable efforts to conduct the Product Development
Program in accordance with the Product Development Plan. IDM shall be the Sponsor of any
clinical trial based upon the Cell-based Vaccine or the Product.

     (b) All expenses incurred by IDM in connection with the Product
Development Program consisting of internal research and development costs or payments to Medarex
pursuant Section 4 of this Agreement (collectively, the “Anti-CTLA-4 Costs”) shall be credited
to IDM’s research funding obligation pursuant to the Technology Access Agreement and performance
of this Agreement by Medarex shall be deemed performance in full of Medarex’s obligations under
Section 3.3 of the Technology Access Agreement. The Anti-CTLA-4 Costs shall be included as a
separate line item in IDM’s periodic financial reports to Medarex.

     (c) If the Product Development Program is terminated or abandoned prior to IDM’s
fulfillment of its research funding obligation pursuant to the Technology Access Agreement, the
parties shall negotiate and agree on the manner in which the unspent balance shall be expended
for the mutual benefit of the parties. If the parties cannot reach agreement on this matter,
Medarex shall receive [...***...] of the unspent balance in cash.

     2.5 Exchange of Information

     (a) IDM shall provide to Medarex all scientific and clinical data relating to the Antibody
generated in the course of the Product Development Program at least every three (3) months in
the form of updated written reports, or in any other fashion presenting such data in an
organized and reproducible manner (e.g. electronic files). IDM shall have the right to redact
from any such reports or information any information that relates to the Cell-Based Vaccine or
any Subcomponents thereof. Within thirty (30) days after the end of each Contract Year, or as
otherwise required by the Steering Committee, IDM shall provide to Medarex a written progress
report, which shall (i) describe any research, development or commercialization activities with
respect to the Product and the Product Components that it has performed, or caused to be
performed, since the last such report, (ii) evaluate the work performed in relation to the goals
of this Agreement and the Product Development Plan, and (iii) provide such other information as
may be reasonably requested by Medarex. In addition to the 3-month scientific reports and the
annual progress reports to be provided hereunder, it is contemplated that the parties shall
maintain informal communications through the Steering Committee and their day-to-day activities
under this Agreement. Any information disclosed by IDM pursuant to this Section 2.5(a) shall be
Confidential Information and subject to the provisions of Section 10.

     (b) Within thirty (30) days after the end of each Contract Year, or as otherwise required
by the Steering Committee, Medarex shall provide to IDM a written progress report of new
scientific and clinical data generated in the course of the Medarex Development Programs as
Medarex in its reasonable discretion may deem to be necessary for the Product Development
Program or for preparing and filing BLAs for the Product;

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

8

 

provided that Medarex shall not be required to disclose any such data that is subject to
any confidentiality obligations that Medarex has vis-a-vis third parties. Any information
disclosed by Medarex pursuant to this Section 2.5(b) shall be Confidential Information and
subject to the provisions of Section 10.

     2.6 Regulatory Filings and Approvals.

          (a) Manufacturing Approvals. Medarex shall be responsible for any filings, permits and
approvals necessary for the manufacture of the Antibody pursuant to the Medarex Development
Programs. Medarex shall be responsible for the costs and expenses incurred by it in connection
with the filings, permits and approvals made or obtained pursuant to this subsection 2.6(a). If
Medarex discontinues all Medarex Development Programs and if IDM decides to fund the process
development for the Antibody, then IDM shall bear the costs and expenses incurred by Medarex
following such discontinuance in connection with such filings, permits and approvals.

          (b) Marketing Authorization Approvals for the Antibody.

               (i) Medarex shall be responsible for preparing and filing at its own expense the BLAs and any
other regulatory filings, permits and approvals necessary for the distribution and
commercialization of the Antibody in the course of performing the Medarex Development Program.

               (ii) If Medarex has not filed a BLA for the Antibody in a country where IDM has filed a BLA
for the Cell-based Vaccine, Medarex shall, at IDM’s written request and expense, file a BLA for the
Antibody in such country. Medarex shall use for such filings any data and information it has
previously used for the filing of BLAs in other countries. If additional information is needed for
the filing of a BLA and obtaining Marketing Authorization Approval in such country, Medarex shall
provide such additional information at IDM’s cost and expense; provided that if Medarex has
abandoned all Medarex Development Programs, and if so requested by Medarex, IDM shall provide such
additional information at IDM’s cost and expense.

               (iii) If Medarex starts selling the Antibody in a country under a Marketing Authorization
Approval for which IDM has borne Medarex’s costs and expenses pursuant to the preceding subsection
2.6(b)(ii), Medarex shall reimburse IDM all of such costs and expenses previously paid for by IDM.

          . (c) Marketing Authorization Approvals for the Product.

               (i) IDM shall, in its sole discretion be responsible for preparing and filing the BLAs for
the Cell-based Vaccine and the simultaneous use of the Cell-based Vaccine and the Antibody as the
Product by cross-referencing the BLAs or Marketing Authorization Approvals filed or obtained by
Medarex for the Antibody, and the clinical data for concomitant use of the Cell-based Vaccine and
the Antibody generated in the course of the Product Development Program (the “Product BLA”).

9

 

               (ii) IDM shall provide to Medarex full access to all data and information compiled in
support of the Product BLAs. IDM shall provide to Medarex copies of all correspondence to and from
Regulatory Authorities relating to the Product BLAs, and shall duly consider in its responses to
Regulatory Authorities any comments and information that Medarex may provide. Medarex shall have
the right to attend as a silent observer any meetings and conference calls with Regulatory
Authorities that may include a discussion of issues relating to a Product or the Antibody.

     2.7 Limited Use.

          (a) IDM covenants to use the Antibody solely for purposes of conducting the Product
Development Program, and not to use the Antibody for any other purpose including any research,
development or commercialization outside the Field, or any sale or transfer of Antibody to a third
party for a purpose other than performing tasks identified in the Product Development Plan. Any
breach of this subsection 2.7(a) by a third party that receives the Antibody from IDM or pursuant
to an agreement with IDM shall be deemed to be a breach committed by IDM.

          (b) Only the right to use the Antibody for the Product Development Program granted pursuant to
the express terms of this Agreement shall be of any legal force or effect. No other rights to the
Antibody, or to any other intellectual property of Medarex, either express or implied, shall be
granted or created by estoppel or otherwise. The parties understand and agree that Medarex shall
retain rights to make, have made, import, use, offer for sale, sell and otherwise commercialize the
Antibody, itself or with third parties, for any use.

          (c) IDM acknowledges that limitations and restrictions on its possession and use of the
Antibody hereunder are necessary and reasonable to protect Medarex, and expressly agrees that
monetary damages would be inadequate to compensate Medarex for any violation by IDM of any such
limitations or restrictions. The parties agree that any such violation would cause irreparable
injury to Medarex and agree that without resorting to prior mediation or arbitration, and, in
addition to any other remedies that may be available in law, in equity or otherwise, Medarex may be
entitled to seek temporary and permanent injunctive relief against any threatened violation of such
limitations or restrictions or the continuation of any such violation in any court of competent
jurisdiction, without the necessity of proving actual damages.

     2.8 Supply of Antibody for Commercial Use.

          (a) If IDM requires Antibody for clinical trials intended for use in Marketing Authorization.
Approval applications and if Medarex has not developed a commercial scale manufacturing process for
the Antibody at that time, the parties shall meet to discuss and negotiate in good faith a process
development plan and the terms for an agreement between the parties regarding the process
development and the supply of Antibody to IDM for use in such clinical trials.

          (b) If Medarex is selling the Antibody pursuant to an approved BLA in a country at the time
IDM, or an Affiliate or licensee of IDM, obtains approval of the Product BLA in that country, IDM
or its customers shall purchase the Antibody from Medarex’s

10

 

distributors in that country. Notwithstanding the foregoing, upon request of IDM, the Parties
will discuss in good faith alternative supply arrangements for the Antibody with respect to those
countries where the Product is being sold.

          (c) If Medarex is not selling the Antibody pursuant to an approved BLA in a country at the
time IDM obtains BLA approval for the Cell-based Vaccine in that country, Medarex shall supply to
IDM or its Affiliates or licensees the Antibody pursuant to an agreement for the supply of
Antibodies for commercial use. The parties shall commence good faith negotiations regarding such
agreement promptly after IDM or its Affiliate or licensee has filed the Product BLA. The terms of
such agreement shall include without limitation the term of the supply arrangements, customary
warranty, indemnification and liability provisions, an obligation of IDM to make milestone payments
as provided in Exhibit C hereto, provisions related to the number of months for which IDM or its
Affiliates or licensees shall make a rolling forecast, the time at which such forecasts shall
become binding, the percentage by which IDM may vary or reschedule binding orders (subject to
limitations to be agreed upon), volume-based pricing, and other terms that are customary in
connection with the manufacture and supply of biopharmaceutical products.

3. Forecasts; Orders; Deliveries

     3.1 Forecasts. Within thirty (30) days after the Effective Date and on or before each
anniversary of the Effective Date, the Steering Committee shall determine the quantities of
Antibody required by IDM during the Contract Year following such date. In addition, the Steering
Committee shall determine the schedule of delivery dates for such quantities subject to Medarex’s
manufacturing capacity, and Medarex’s own requirements and supply commitments to third parties,
provided however that if the available supply of Antibody is not sufficient to meet the demand
therefore after Medarex’s requirements have been met, orders will be filled on a first come first
serve basis.

     3.2 Orders.

          (a) Not more than once every six (6) months during the term of this Agreement, IDM shall
place orders in quantities corresponding to complete Batches in accordance with the
forecasts and the delivery schedules prepared by the Steering Committee pursuant to Section 3.1
above, provided that Medarex shall use good faith efforts to supply quantities of Antibody in
excess of the forecasted quantities upon request of IDM, subject to available manufacturing
capacity and Medarex’s own requirements and supply obligations to third parties. Medarex shall
fulfill all purchase orders that IDM places in accordance with this Section 3 that are within the
quantity limitations and that adhere to the delivery schedule agreed upon by the Steering Committee
pursuant to Section 3.1.

          (b) Any purchase orders for Antibody submitted by IDM shall reference this Agreement and shall
be governed exclusively by the terms contained herein. Any term or condition in any order,
confirmation or other document furnished by IDM or Medarex which is different from or in addition
to the terms of this Agreement is hereby expressly rejected.

11

 

     3.3 Deliveries. Unless otherwise agreed by the parties in writing, all QC Samples and
Batches of Antibody shall be delivered FCA (Incoterms 2000) Medarex’s facility. Medarex shall not
deliver any Batch of Antibody until IDM accepts or is deemed to have accepted the QC Sample in
accordance with the provisions of Section 5.3(a), or a third party laboratory reasonably
acceptable to both Medarex and IDM determines that a sample of a Batch meets Specifications in
accordance with the provisions of Section 5.3(b).

4. Price; Payments

     4.1 Price. The price of Antibody ordered by IDM shall be Medarex’s cost of goods of the
Antibody calculated in accordance with US GAAP consistently applied plus [...***...]. The “cost of
goods”, shall include any payments made by Medarex to its direct and indirect licensors through
multiple tiers of licenses that become due as a result of the performance of this Agreement by
Medarex or IDM.

     4.2 Method of Payments. All payments due under this Agreement to Medarex shall be paid in
United States Dollars not later than forty-five (45) days following the receipt of the applicable
invoice. Any invoiced amount not paid by its due date shall be assessed a late payment fee at the
rate of one percent (1%) per month, or the maximum rate permitted by applicable law with respect to
such obligations, whichever is less.

5. Product Warranty; Acceptance and Rejection

     5.1 Limited Warranty. Medarex warrants that (a) each Batch of Antibody delivered hereunder
shall have been manufactured in accordance with cGMP and in accordance with the manufacturing
procedures described in the master batch records, as may be modified in accordance with the
provisions of Section 6.1, and (b) each QC Sample and Batch conforms to the Specifications at the
time of delivery pursuant to Section 3.3. This warranty is the only warranty made by Medarex with
respect to Antibodies. THE EXPRESS WARRANTY IN THIS SECTION 5.1 IS IN LIEU OF ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING THE WARRANTIES OF MERCHANTABILITY, FITNESS
FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT OF THIRD PARTY RIGHTS.

5.2 Delivery Documentation; Testing.

          (a) Prior to the delivery of a Batch of Antibody, Medarex shall provide IDM with (i) a
certificate of analysis confirming that the Batch has been tested and meets the Specifications,
(ii) a written confirmation that such batch records have been reviewed and approved by Medarex’s
quality assurance unit, and (iii) a sample of sixty (60) milligrams drawn from such Batch (the “QC
Sample”). In addition, IDM may inspect at Medarex’s facility a copy of the batch records during
business hours upon reasonable advance notice.

          (b) IDM may retest the QC Samples and Batches upon receipt to confirm that they meet
Specifications.

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

12

 

     5.3 Acceptance and Rejection.

          (a) IDM may reject a QC Sample or Batch which does not meet the Specifications by
providing notice thereof to Medarex. Any such notice of rejection shall be in writing and shall
indicate the reasons for such rejection, and must be received by Medarex within (i) fifteen (15)
days after delivery by Medarex of the QC Sample and the associated documentation or (ii)
thirty (30) days after delivery by Medarex of a Batch and the associated documentation (each, a
“Testing Period”). If no such notice of rejection is received by Medarex within the applicable
Testing Period, IDM shall be deemed to have accepted such QC Sample or the Batch of Antibody upon
the expiration of the applicable Testing Period. Medarex shall be authorized to make delivery of
the full Batch of Antibody only after acceptance of the QC Sample. Once IDM accepts or is deemed to
have accepted a Batch of Antibody, IDM shall have no recourse against Medarex if Antibody of that
Batch is subsequently deemed unsuitable for use for any reason.

          (b) If IDM provides a notice of rejection, Medarex shall notify IDM as promptly as reasonably
possible whether it accepts IDM’s basis for the rejection. IDM shall cooperate with Medarex in
determining whether the rejection is justified. If Medarex disagrees with IDM’s determination that
a QC Sample or a Batch does not meet the Specifications, a sample drawn from the corresponding
Batch of Antibody shall be submitted to a mutually acceptable third party laboratory. Such third
party laboratory shall determine whether such sample meets the Specifications and the parties agree
that such laboratory’s determination shall be final and determinative. The party against whom the
third party tester rules shall bear all costs of the third party testing.

          (c) Medarex shall investigate, and cooperate fully with IDM in investigating, the cause for
any QC Sample or Batch failing to meet Specifications. Medarex shall keep IDM informed of the
status of any investigation and, upon completion of the investigation, shall provide IDM with a
final written report describing the cause of the failure and summarizing the results of the
investigation.

     5.4 Remedy for Breach of Limited Warranty. If IDM has rejected a QC Sample or a Batch as
provided in Section 5.3(a) and Medarex agrees or third party tests confirm that a QC Sample or
Batch does not meet Specifications as provided in Section 5.3(b), or if a Batch is otherwise not in
compliance with the warranty made in Section 5.1, Medarex shall use commercially reasonable efforts
to promptly repair such nonconformance or manufacture a replacement Batch AT NO COSTS FOR
IDM. THE REMEDY OF REPAIR OR REPLACEMENT AT NO COST FOR IDM PROVIDED FOR IN THIS
SECTION 5.4 IS IDM’S SOLE AND EXCLUSIVE REMEDY FOR BREACH OF THE LIMITED WARRANTY OF SECTION 5.1,
AND IS IN LIEU OF ALL OTHER REMEDIES THAT MAY OTHERWISE BE AVAILABLE TO IDM IN LAW OR IN EQUITY.

6. Regulatory Matters

     6.1 Changes to Specifications and Manufacturing Process.

13

 

          (a) The Steering Committee shall discuss and use good faith efforts to agree on
modifications to the Specifications or the manufacturing process that may be requested by either
party in order to comply with any requirements of the FDA, or to reflect a party’s experience with
the manufacture, testing and use of the Antibody. IDM shall provide Medarex with written notice of
any regulatory requirements of countries relating to the manufacture of Antibody that deviate from
the requirements applicable in the United States. Medarex shall inform the Steering Committee as to
the feasibility and cost of implementing changes necessary to comply with such non-US requirements,
and the Steering Committee shall discuss and use good faith efforts to agree on the implementation
of such changes. Medarex shall not be obligated to bear any costs of implementing changes pursuant
to this subsection 6.1 (a), provided that if Medarex does not wish to bear such costs with respect
to changes requested by the FDA or its equivalent in countries in the EU or Japan, IDM shall bear
such costs, provided that in such event, IDM shall not be required to make the milestone payment
set forth in Exhibit C with respect to the country for which IDM bears the costs of implementing
the changes.

          (b) Medarex shall notify IDM before it implements any change in the materials, equipment,
process or procedures used to manufacture Antibody that would constitute a major change under cGMP.
Medarex shall disclose all such proposed major changes in such manufacturing materials, equipment,
process or procedure to IDM at a level sufficient to allow IDM to assess the impact of the changed
manufacturing process on the clinical trials with the Product and the filing of the BLA for the
Product. IDM shall inform Medarex within thirty (30) days if such proposed change would require
repeating a clinical trial or would otherwise materially delay the filing of such BLA. Promptly
upon receipt of such notice by Medarex, the parties shall meet to discuss and use good faith
efforts to agree on how to proceed.

     6.2 Regulatory Support for Clinical Trial Applications.

To the extent necessary for IDM to obtain regulatory approvals, including INDs, and notification
dossiers to initiate clinical trials, Medarex shall assist IDM by providing directly to the
Regulatory Authorities any available information regarding Chemistry, Manufacturing and Control of
the Antibody, preclinical studies or clinical investigations that is requested by a national
health authority and if necessary, submit a DMF, or other comparable document in connection with
the manufacturing of the Antibody. Where necessary, Medarex shall provide IDM with letters of
reference to any DMF or other comparable filings made by it in connection with the manufacture of
the Antibody. Medarex shall at least annually provide IDM with an updated Investigator Brochure
for the Antibody. If Regulatory Authorities request information that is not available and must be
generated in response to such requests, the Steering Committee shall discuss and agree on the
appropriate course of action.

     6.3 Regulatory Support for BLA and MAA. To the extent necessary for IDM to obtain Marketing
Authorization Approvals for and to commercialize the Product, Medarex shall provide IDM with
letters of reference to any DMF or other comparable filings made by it in connection with the
manufacture of the Antibody. Medarex agrees to cooperate with any inspection by a Regulatory
Authority, including any inspection prior to Marketing Authorization Approval of the Product or the
Antibody. The parties understand that if such assistance and cooperation requires substantial
expenditures by Medarex, IDM shall reimburse Medarex therefor upon receipt of invoices from
Medarex.

14

 

     6.4 cGMP Compliance and QA Audits. Upon written request to Medarex, IDM shall have the
right to have representatives visit Medarex’s manufacturing facilities where the Antibody is
manufactured no more than twice per year and during normal business hours, to review Medarex’s
manufacturing operations and assess its compliance with cGMP and quality assurance standards and to
discuss any related issues with Medarex’s manufacturing and management personnel. Such written
request shall be made at least thirty (30) days before the requested date of IDM’s visit.

     6.5 Adverse Event Reporting.

          (a) IDM shall provide to Medarex within forty-eight (48) hours all
information and reports received by IDM or third parties engaged in the Product Development Program
relating to unexpected, drug-related SAEs experienced by subjects in clinical trials with the
Product or the Antibody, and shall keep Medarex informed of the progress and the results of any
investigation of such SAE. Adverse events that are not SAEs shall be reported to Medarex in the
reports provided pursuant to Section 2.5(a).

          (b) Medarex shall provide to IDM within five (5) business days all
information and reports received by Medarex relating to unexpected, drug-related, SAEs
experienced by subjects in clinical trials with the Antibody, and shall keep EDM informed of the
progress and the results of any investigation of such Serious Adverse Event.

          (c) IDM and Medarex will mutually exchange information necessary to comply with the
requirement for annual IND reports, or to complete IND ad-hoc reports.

 7 Intellectual Property

     7.1 Inventorship. Inventorship of any Inventions arising out of the Product
Development Program shall be determined according to U.S. law.

     7.2 Sole Ownership.

          (a) Each party acknowledges that any pre-existing intellectual property of the other party is
and shall continue to be solely owned by such other party, subject to the rights granted herein.

          (b) Each party shall own any Inventions that are conceived solely by it or its agents,
contractors or collaborators during and in the course of developing the Antibody and the Cell-based
Vaccines (each a “Sole Invention”), and all patent applications and patents claiming only Sole
Inventions. Without limiting the generality of the foregoing, any Inventions claiming the use of
the Antibody in combination with the Cell-based Vaccine conceived solely by IDM or its agents,
contractors or collaborators (each a “Combination Invention”) shall be solely owned by IDM. IDM
shall promptly notify Medarex of any such Combination Invention.

     7.3 Joint Ownership.

15

 

          (a) The parties shall jointly own any Inventions that are conceived jointly by Medarex
and IDM or their agents, contractors or collaborators during and in the course of developing the
Antibody and the Cell-based Vaccines (each a “Joint Invention”), and all patent applications and
patents claiming Joint Inventions (“Joint Patents”). The Parties shall cooperate to ensure that any
patent applications filed for Sole Inventions of one party do not claim any Joint Inventions or
Sole Inventions of the other party, and that any patent applications filed for Joint Inventions do
not claim any Sole Inventions of the parties.

          (b) In the event that either party believes that any Invention that is made in the course of
performance under this Agreement may be a Joint Invention, such party shall so notify the Steering
Committee. The Steering Committee shall thereafter meet in good faith to determine whether such
Invention is a Joint Invention. In the event the Steering Committee is unable to make such
determination, each party shall designate an experienced intellectual property attorney (in the
case of determining inventorship of a possibly patentable invention, a registered United States
patent attorney). Such attorneys shall cooperate in good faith to resolve any such inventorship
issues, applying prevailing United States law, rules and interpretations for determining
inventorship and ownership.

          (c) IDM shall have the right to grant licenses to its rights and interest in any Joint Patents
as may be appropriate for the research, development and commercialization of the Cell-based
Vaccine, without consent of or obligation to account to Medarex. Medarex shall have the right to
grant licenses to its rights and interest in any Joint Patents as may be appropriate for the
research, development and commercialization of the Antibody, without consent of or obligation to
account to IDM. Except as expressly provided in this subsection 7.3(c), neither party shall grant
a license to its rights and interest in any Joint Patents to any third party without the express
written consent of the other party, which consent shall not be unreasonably withheld.

     7.4 Grant of Rights.

          (a) Grant of Rights to IDM.

               (i) Rights of Use and Reference. Medarex hereby grants IDM, and its Affiliates directly or
indirectly the right and license to use, practice, exploit and reference [...***...] all Marketing
Authorization Approvals, and any know-how, information and data disclosed by Medarex to IDM
pursuant to Section 2.5(b) of this Agreement, solely for (1) the development of Products in the
Field, and (2) the filing of BLAs and obtaining of Marketing Authorization Approvals for Products
in the Field.

               (ii) License to Cell-based Vaccine Inventions. Medarex hereby grants to IDM a worldwide,
exclusive license with the right to grant and authorize the grant of sublicenses through multiple
tiers of sublicensees under Medarex’s Sole Patents and its rights and interest in Joint Patents,
each claiming Inventions directly related to the composition of matter of the Subcomponents of the
Cell-based Vaccine, the method of use of the Cell-based Vaccine separate from the Antibody, or the
method of making the Subcomponents of the Cell-based Vaccine, solely (1) to practice such
Inventions in the Field, and (2) to make, use, offer to sell, sell and import Products in the
Field. If during the term of this Agreement Medarex obtains licenses under Patents of Third Parties
relating to the Antibody, Medarex shall use good faith

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

16

 

reasonable efforts to obtain the right to grant sublicenses under such licenses to IDM for
use in connection with a Cell-based Vaccine, provided that IDM shall assume any payments due to
such Third Party as a result of the grant or exercise of such sublicense rights to the extent not
already included in the cost of goods as provided in Section 4.1.

               (iii) Consideration. In consideration of the rights and licenses granted to IDM pursuant to
this subsection (a), IDM shall make to Medarex the payments set forth in Exhibit C hereto.

          (b) Grant of Rights to Medarex.

               (i) Rights of Use and Reference. IDM hereby grants to Medarex, its Affiliates, and its
licensees the right and license to use, practice, exploit and reference, and to grant and
authorize the grant of sublicenses under such rights through multiple tiers of sublicensees, all
Marketing Authorization Approvals for the Antibody, and all information provided to Medarex
pursuant to Section 2.5(a), for the research and development, the filing and obtaining of
regulatory approvals, and the commercialization of products.

               (ii) License to Antibody Inventions. IDM hereby grants to Medarex a worldwide, exclusive
license with the right to grant and authorize the grant of sublicenses through multiple tiers of
sublicensees under IDM’s Sole Patents and its rights and interest in Joint Patents, each claiming
Inventions directly related to the composition of matter of the Antibody, the method of use of the
Antibody other than in combination with any Cell-based Vaccine, or the method of making the
Antibody, to practice such Inventions, and to make, use, offer to sell, sell, and import products.

               (iii) Consideration. In consideration of the rights and licenses granted
to Medarex pursuant to this subsection 7.4(b), Medarex shall make the following payments to IDM:

                    (1) If Medarex grants a sublicense to a third party under, or
otherwise grants a third party access to, the rights granted to Medarex pursuant to Section
7.4(b)(i) above for a Competitive Use, Medarex shall share with IDM all Net Revenues received by
Medarex in connection with such sublicense based on a [...***...] ratio, such that Medarex shall
receive [...***...] of all Net Revenues derived from such licensing, and IDM shall receive [...***...] of
all Net Revenues derived from such licensing. As used herein, the term “Competitive
Use” shall mean the research, development or commercialization of a Cell-based Vaccine
for an indication listed in Exhibit A hereto.

                    (2) If Medarex grants a sublicense to a third party under any
patents licensed to Medarex pursuant to 7.4(b)(ii) above, Medarex shall pay IDM the following Net
Revenues received by Medarex in connection with such sublicense:

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

17

 

	 	 	 	 	 
	 	 	Sublicense of IDM's Sole Patents	 	Sublicense of Joint Patents
	Naked Sublicense

	 	[...***...]
	 	[...***...]
	Combined Sublicense

	 	[...***...]
	 	[...***...]

     “Naked Sublicense” shall mean a sublicense under the license granted under Section
7.4(b)(ii) that is granted by Medarex without the grant of a license under any other patent
applications or patents owned or licensed by Medarex. “Combined Sublicense” shall mean a
sublicense under the license granted in Section 7.4(b)(ii) that is granted by Medarex in
connection with the grant of a license under any other patent applications or patents owned or
licensed by Medarex. The percentage rates set forth in the above table shall not be cumulative,
and Medarex shall share with IDM Net Revenues calculated based on the highest percentage rate
listed in the above table that may apply to a particular sublicense transaction.

     7.5 Patent Prosecution and Enforcement for Joint Patents.

          (a) Steering Committee. The Steering Committee shall designate, subject to approval by the
Chief Executive Officers of the respective parties or their designees, the party (the “Designated
Party”) that shall be responsible for the filing, prosecution and maintenance of Joint Patents in
both parties’ names with due regard to reasonable concerns, if any, expressed by either party as
to the impact such a filing and prosecution may have on its other rights and technologies, taking
into account the nature of the Joint Patent, and the relationship of such Joint Patent to the
business of each party.

          (b) Designated Party to Control. Except as otherwise provided in this Section 7.5, the
Designated Party shall prosecute and maintain each Joint Patent for which it is responsible using
counsel mutually agreed between the parties, under the direction and control of the Designated
Party. The parties shall equally share the costs of prosecution and maintenance of Joint Patents,
hi the event that either party declines to share such costs, all rights to such Joint Patents
shall revert to the other party in accordance with subsection 7.5(f) below. Periodically, but at
least quarterly (and not less than sixty (60) days prior to the next upcoming deadline), the
Designated Party shall advise the other party in writing of all upcoming deadlines in connection
with Joint Patents. Unless advised to the contrary by the other party within thirty (30) days of a
deadline for taking action with respect to a particular Joint Patent, the Designated Party shall
take the required action. If the Designated Party fails to take a required action in connection
with a particular element of a Joint Patent by five (5) business days before the non-extendable
deadline for taking such action, the other party shall have the right, but not the obligation, to
take the required action.

          (c) Invoicing. The Designated Party shall invoice the other party for such other party’s
share of the prosecution and maintenance costs as they are incurred, which invoices shall be paid
by such other party within thirty (30) days of receipt thereof.

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

18

 

          (d) Cooperation. At the request of the Designated Party, the other party shall provide
reasonable cooperation in connection with prosecution or maintenance of Joint Patents. Each party
shall make available to the other party or its respective authorized attorneys, agents or
representatives such of its employees as the other party in its reasonable judgment deems necessary
in order to assist such other party with such prosecution or maintenance. Each party shall sign or
use its best efforts to have signed at no charge to the other party all legal documents necessary
in connection with such prosecution and maintenance.

          (e) Updates on Developments. The Designated Party shall advise the other party of any
substantial action or development in the prosecution and maintenance of registrations and
applications for registration of Joint Patents, and shall provide the other party with copies of
all material correspondence, including correspondence with the U.S. Patent and Trademark Office,
and other U.S. and foreign governmental authorities, in connection with Joint Patents. The
Designated Party shall provide the other party with a report no less frequently than once per year
listing all such registrations and applications being handled by the Designated Party, identifying
them by country and patent, registration or application number, and briefly describing the status
thereof.

          (f) Designated Party Abandonment. The Designated Party shall not disclaim, dedicate,
or otherwise abandon any Joint Patents without the express written consent of the other party. In
the event that a Designated Party declines or ceases to prosecute or maintain a Joint Patent, such
party shall immediately notify the other party, and the other party shall thereafter have the right
to prosecute or maintain such Joint Patent, in its sole discretion, provided that all rights of the
declining party in such Joint Patent, shall be assigned to the other party in their entirety, and
the declining party shall thereafter have no right to make, have made, offer for sale, sell, use,
import or export products that infringe patents claiming Joint Patents.

          (g) Infringement of Joint Patents.

               (i) In the event that any party obtains knowledge of any infringement or misappropriation by
a third party of any Joint Patents, such party shall inform the other party promptly of such
infringement and provide the other party with any available evidence of such infringement or
misappropriation.

               (ii) Medarex shall have the exclusive right to commence, prosecute, and settle or otherwise
compromise any dispute, action, suit, or proceeding involving or against any third party believed
to have infringed or misappropriated any Inventions relating to the Antibody in any Joint Patents
licensed to it pursuant to Section 7.4(b)(ii).

               (iii) JDM shall have the exclusive right to commence, prosecute, and settle or otherwise
compromise any dispute, action, suit, or proceeding involving or against any third party believed
to have infringed or misappropriated any Inventions relating to the Cell-based Vaccines or
Subcomponents thereof in any Joint Patents licensed to it pursuant to Section 7.4(a)(ii).

               (iv) Each party hereby agrees to be bound by the outcome of any such action, suit or
proceeding or by any settlement or other compromise for any and all purposes

19

 

brought by the other party. All costs and expenses of such action, suit or proceeding shall
be borne by the party initiating such action. Each party agrees to cooperate with the other party
in any such action, suit or proceeding, in any way reasonably necessary, including being named as
a party to such action if so requested by the other party or required by law. Each party shall
have the right to participate in and be represented by its own counsel at its own expense in any
such action, suit or proceeding brought by the other party. Neither party shall have a claim of
any kind against the other party based on or arising out of a party’s handling of or decisions
concerning any such action, suit, proceeding, settlement, or compromise, and each party hereby
irrevocably releases the other party from any such claim. The initiating party may discontinue
such action, suit or proceeding if in its sole discretion it determines that such action, suit or
proceeding is not advantageous to that party.

               (v) All damages or other compensation of any kind recovered in any action, suit, or
proceeding or from any settlement or compromise brought under this Section 7.5(g) shall be for the
benefit of the party that brought such action, suit, or proceeding.

     7.6 Patent Prosecution and Enforcement for Solely Owned Intellectual Property.

          (a) The party that is the sole owner of an Invention shall be responsible for the filing,
prosecution and maintenance of the patent application and issued patent claiming such Invention, at
its own cost and expense.

          (b) With respect to Sole Patents licensed to the other party pursuant to Section 7.4 (the
“Licensed Sole Patent”), the owner of the Licensed Sole Patent shall advise the other party in
writing of all upcoming deadlines in connection with Licensed Sole Patents periodically, but at
least quarterly (and not less than sixty (60) days prior to the next upcoming deadline).

          (c) At the request of the owner of the Licensed Sole Patent, the other party shall provide
reasonable cooperation in connection with prosecution or maintenance of the Licensed Sole Patent.
Each party shall make available to the other party or its respective authorized attorneys, agents
or representatives such of its employees as the other party in its reasonable judgment deems
necessary in order to assist such other party with such prosecution or maintenance. Each party
shall sign or use its best efforts to have signed at no charge to the other party all legal
documents necessary in connection with such prosecution and maintenance.

          (d) The owner of the Licensed Sole Patent shall advise the other party of any substantial
action or development in the prosecution and maintenance of registrations and applications for
registration of Licensed Sole Patents, and shall provide the other party with copies of all
material correspondence, including correspondence with the U.S. Patent and Trademark Office, and
other U.S. and foreign governmental authorities, in connection with Licensed Sole Patents. The
owner of the Licensed Sole Patent shall provide the other party with a report no less frequently
than once per year listing all such registrations and applications being handled by the owner,
identifying them by country and patent, registration or application number, and briefly describing
the status thereof.

          (e) The owner of a Licensed Sole Patent shall not disclaim, dedicate, or otherwise abandon any
Licensed Sole Patent without the express written consent of the other

20

 

party. In the event that the owner of a Licensed Sole Patent declines or ceases to prosecute
or maintain a Licensed Sole Patent, such party shall immediately notify the other party, and the
other party shall thereafter have the right to prosecute or maintain such Licensed Sole Patent, in
its sole discretion, provided that all rights of the declining party in such Licensed Sole Patent,
shall be assigned to the other party in their entirety, and the declining party shall thereafter
have no right to make, have made, offer for sale, sell, use, import or export products that
infringe Licensed Sole Patents.

          (f) In the event that any party obtains knowledge of any infringement or misappropriation by
a third party of any Licensed Sole Patent, such party shall inform the other party promptly of
such infringement and provide the other party with any available evidence of such infringement or
misappropriation. The owner of a Licensed Sole Patent shall have the exclusive right to commence,
prosecute, and settle or otherwise compromise any dispute, action, suit, or proceeding involving
or against any third party believed to have infringed or misappropriated any Licensed Sole Patent.

     7.7 Patent Prosecution and Enforcement for Combination Inventions.

          (a) IDM shall be solely responsible, at its expense and in its sole discretion, for the
preparation, filing, prosecution and maintenance of the patent applications and patents claiming
Combination Inventions, and for conducting any interferences, reexaminations, reissues,
oppositions, or request for patent term extension relating thereto.

          (b) The provisions of Section 7.6 regarding Licensed Sole Patents shall apply mutatis mutandis
to patent applications and patents claiming Combination Inventions.

     7.8 Antibody Intellectual Property. Subject to any obligations of non-disclosure or
confidentiality to third parties, Medarex shall advise IDM of any substantial actions or
developments in (i) Medarex’s prosecution and maintenance of registrations and applications for
registration of patents related to the Antibody and (ii) any negotiations of Medarex with third
parties after the Effective Date regarding patents owned by such third parties that may be
infringed by the manufacture of the Antibody by Medarex or the use of the Antibody as a Product
Component.

     7.9 Infringement of Third Party Rights.

          (a) If the manufacture, importation, sale or use of a Cell-based Vaccine or the Antibody
pursuant to this Agreement results in any claim, suit or proceeding against Medarex or IDM alleging
infringement or misappropriation of an intellectual property right of a third party, such party
shall promptly notify the other party hereto. Each party shall keep the other party informed of
all material developments in connection with any such claim, suit or proceeding.

          (b) If a third party threatens in writing to file, or files, a complaint that the manufacture
or use of the Antibody by Medarex or IDM infringes that third party’s intellectual property rights,
Medarex shall use commercially reasonable efforts (i) to obtain, a license from such third party
with a right to sublicense to IDM, its Affiliates and licensees, as necessary for Medarex to
perform its obligations under this Agreement and for IDM, its Affiliates and licensees to develop
and use the Product pursuant to this Agreement, or (ii) to take such other

21

 

actions as Medarex deems appropriate to defend against such claim. If Medarex (x) is unable
to secure such license under terms that it deems in its discretion to be commercially reasonable,
or (y) determines that it may not prevail or does not prevail in any action against such third
party, Medarex’s obligation to supply Antibody under this Agreement shall be suspended, and the
parties shall meet to discuss how to best proceed. If the parties are unable to reach agreement on
a course of action, Medarex shall have the right to terminate this Agreement by written notice.

8. Representations And Warranties; Limitation of Liability

     8.1 Mutual Representations and Warranties. Each party hereby represents and warrants to the
other party as follows:

          (a) It is duly organized, validly existing and in good standing under the laws of the state in
which it is organized.

          (b) It has the power and authority and the legal right to enter into the Agreement and to
perform its obligations hereunder, and has taken all necessary action on its part to authorize the
execution and delivery of the Agreement and the performance of its obligations hereunder.

          (c) The Agreement has been duly executed and delivered on its behalf, and constitutes a legal,
valid, binding obligation, enforceable against it in accordance with its terms.

          (d) The execution and delivery of the Agreement and the performance of its obligations
hereunder (i) do not conflict with or violate any requirement of applicable laws or regulations,
and (ii) do not conflict with, or constitute a material default or require any consent under, any
of its agreements.

     8.2 Limitation of Liability.

          (a) EXCEPT FOR BREACHES OF SECTION 2.7 OR 10, AND EXCEPT FOR EACH PARTY’S INDEMNIFICATION
OBLIGATIONS PURSUANT TO SECTION 9, IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR ANY CONSEQUENTIAL,
EXEMPLARY, SPECIAL, PUNITIVE, INCIDENTAL            OR RELIANCE            DAMAGES, INCLUDING ANY
LOST PROFITS, ARISING FROM OR RELATING TO THIS AGREEMENT, WHETHER IN CONTRACT OR TORT
OR OTHERWISE, EVEN IF SUCH PARTY KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF
SUCH DAMAGES.

          (b) EXCEPT FOR BREACHES OF SECTION 2.7 OR 10, AND EXCEPT FOR EACH PARTY’S INDEMNIFICATION
OBLIGATIONS PURSUANT TO SECTION 9, NEITHER PARTY’S TOTAL CUMULATIVE LIABILITY ARISING FROM OR
RELATED TO THIS AGREEMENT, WHETHER IN CONTRACT OR TORT OR OTHERWISE, SHALL EXCEED THE AMOUNT PAID
TO MEDAREX BY IDM UNDER THIS AGREEMENT.

22

 

          (c) THIS SECTION 8.2 SHALL BE GIVEN FULL EFFECT EVEN IN THE EVENT THAT ANY OF THE
WARRANTIES AND REMEDIES PROVIDED IN SECTION 5.1, 5.4 AND 8.1 ARE DEEMED BY AN ARBITRATOR OR COURT
OF COMPETENT JURISDICTION TO HAVE FAILED OF THEIR ESSENTIAL PURPOSE.

          (d) THE PARTIES ACKNOWLEDGE THAT THE TERMS OF THIS SECTION 8.2 REFLECT THE ALLOCATION
OF RISK THAT HAS BEEN NEGOTIATED AND AGREED UPON BY THE PARTIES AND THAT THE PARTIES WOULD NOT
ENTER INTO THIS AGREEMENT WITHOUT THE LIMITATIONS OF LIABILITY CONTAINED HEREIN.

9. Indemnification

     9.1 By Medarex. Medarex shall indemnify, defend and hold harmless IDM, its Affiliates, and
their respective directors, officers and employees (each an “IDM Indemnitee”) from and against any
and all liabilities, damages, losses, costs or expenses (including attorneys’ and professional fees
and other expenses of litigation and/or arbitration) (“Liabilities”) resulting from a claim, suit
or proceeding made or brought by a third party against an IDM Indemnitee to the extent that such
Liabilities arise from (a) a breach of this Agreement by Medarex, (b) the Process Development
Program, or (c) the negligence or willful misconduct of a Medarex Indemnitee.

     9.2 By IDM. Except to the extent that Medarex has an obligation to indemnify IDM pursuant to
Section 9.1 above, IDM shall indemnify, defend and hold harmless Medarex, its Affiliates, and
their respective directors, officers and employees (each a “Medarex Indemnitee”)
from and against any and all Liabilities resulting from a claim, suit or proceeding made or brought
by a third party against a Medarex Indemnitee, arising from or occurring as a result of (a) a
breach of this Agreement by IDM, (b) the Product Development Program, or (c) the negligence or
willful misconduct of an IDM Indemnitee.

     9.3 Procedure. In the event that a party indemnified hereunder (an “Indemnitee”) intends to
claim indemnification under this Section 9, such Indemnitee shall promptly notify the other party
(the “Indemnitor”) in writing of such alleged liability. The Indemnitor shall have the sole right
to control the defense and settlement thereof. The Indemnitees shall cooperate with the Indemnitor
and its legal representatives in the investigation of any action, claim or liability covered by
this Section 9. The Indemnitee shall not, except at its own cost and risk, voluntarily make any
payment or incur any expense with respect to any claim or suit without the prior written consent of
the Indemnitor, which the Indemnitor shall not be required to give. The Indemnitor shall not be
required to provide indemnification with respect to a Liability the defense of which is prejudiced
by the failure to give notice by the Indemnitee or the failure of the Indemnitee to cooperate with
the Indemnitor or where the Indemnitee settles or compromises a Liability without the written
consent of the Indemnitor.

10. Confidentiality; Publications; Publicity

23

 

     10.1 Obligation. The party receiving Confidential Information (the “Receiving
Party”) from the other party (the “Disclosing Party”) shall maintain in confidence such
Confidential Information and shall not use, disclose or grant use of such Confidential
Information except as expressly authorized by this Agreement. The Receiving Party may disclose
Confidential Information, as authorized hereunder, only to those employees or consultants
of the Receiving Party who need to know such Confidential Information for the purpose of performing
this Agreement, and who are bound by obligations of confidentiality and non-use that are not less
stringent than those contained in this Section 10. The Receiving Party shall promptly notify the
Disclosing Party upon discovery of any unauthorized use or disclosure of the Confidential
Information.

     10.2 Exclusions. The term “Confidential Information” shall not be deemed to include
information which the Receiving Party can demonstrate by competent written proof: (i) is now, or
hereafter becomes, through no act or failure to act on the part of the Receiving Party, generally
known or available; (ii) is known by the Receiving Party at the time of receiving such information
as evidenced by its contemporaneous, written records; (iii) is hereafter furnished to the Receiving
Party by a third party, as a matter of right and without restriction or disclosure, or (iv) is the
subject of a written permission to disclose provided by the Disclosing Party.

     10.3 Permitted Disclosures.

          (a) The obligations of confidentiality under this Section 10 shall not apply to the extent
that the Receiving Party is required to disclose information in support of any regulatory filings,
including Marketing Authorization Approval applications, or by an order or regulation of a
governmental agency, or in the course of litigation, provided that in all cases the Receiving Party
shall give the other party prompt notice of the pending disclosure and shall seek an order
maintaining the confidentiality of the information.

          (b) Either party may file this Agreement as may be required pursuant to applicable securities
laws or regulations of the Securities and Exchange Commission (“SEC”), the French Commission des
Operations de Bourses or their equivalents in other European countries, provided that the party
filing this Agreement shall first confer with the non-filing party regarding which of the
provisions of this Agreement the filing party will seek confidential treatment from the SEC or its
French equivalent and shall reasonably consider the non-filing party’s comments relating thereto.

     10.4 Publications. The parties acknowledge that scientific lead-time is a key element of the
value of the research and development activities under the Product Development Program and further
agree that scientific publications must be strictly monitored to prevent any adverse effect from
premature publication of results of the research or development activities hereunder. At least
sixty (60) days prior to submission of any material related to the Product Development Program for
publication or presentation, IDM shall provide to the Steering Committee a draft of such material
for its review and comment. The Steering Committee shall provide any comments to IDM within sixty
(60) days of receipt of such materials. Failure to provide comments within sixty (60) days will be
taken as a tacit approval. No publication or presentation with respect to the research or
development activities hereunder shall be made unless and until the Steering Committee’s comments
on the proposed publication or presentation have been addressed and

24

 

changes have been agreed upon and any information determined by Medarex to be its
Confidential Information has been removed. If requested in writing by Medarex, IDM shall withhold
material from submission for publication or presentation for an additional sixty (60) days to
allow for the filing of a patent application or the taking of such measures to establish and
preserve proprietary rights in the information in the material being submitted for publication or
presentation.

     10.5 Publicity. Prior to any public disclosure regarding this Agreement, including press
releases, the releasing party shall provide a copy of the proposed release to the other party for
comment prior to release; provided, however, that either party shall have the right to make public
disclosures if so required by applicable laws or regulations of stock exchanges on which such
party’s shares are traded. Once any written statement is approved for disclosure by both parties,
either party may make subsequent public disclosures of the contents of such statement without
further approval of the other party.

11. Duration, Expiration And Termination

     11.1 Term. This Agreement shall be effective for a period of five (5) years from the
Effective Date, or if shorter, the term of the Product Development Program, and may be extended
upon the mutual, written agreement of IDM and Medarex (the initial term and any extension thereof
being collectively referred to as the “Term” hereof).

     11.2 Termination. Either party may terminate this Agreement upon written notice to the other
party if the other party commits any material breach of this Agreement which the breaching party
fails to cure within thirty (30) days following written notice from the nonbreaching party
specifying such breach.

     11.3 Surviving Obligations. Termination or expiration of this Agreement shall not (a) affect
any other rights of either party which may have accrued up to the date of such termination or
expiration, or (b) relieve IDM of its obligation to pay to Medarex sums due in respect of Antibody
delivered prior to termination or expiration of this Agreement. The provisions of Sections 1,
2.6, 4.2, 5.1, 7, 8, 9, 10, 11.3 and 12 shall survive the termination or expiration of this
Agreement. [To be revised once final]

12. General Terms

     12.1 Governing Law, Jurisdiction, Venue and Service.

          (a) This Agreement is made in accordance with and shall be governed and construed under the
laws of the State of New York, excluding (i) any choice of law provisions that would require the
application of laws of a different jurisdiction and (ii) the United Nations Conventions on
Contracts for the International Sale of Goods, as amended.

          (b) Subject to Section 2.2(c)(ii), the parties hereby irrevocably and
unconditionally consent to the exclusive jurisdiction of the courts of the State of New York and
the United States District Court for the Southern District of New York for any action, suit or

25

 

proceeding (other than appeals therefrom) arising out of or relating to this Agreement, and
agree not to commence any action, suit or proceeding (other than appeals therefrom) related
thereto except in such courts.

          (c) The parties further hereby irrevocably and unconditionally waive any objection to the
laying of venue of any action, suit or proceeding (other than appeals therefrom) arising out of or
relating to this Agreement in the courts of the State of New York or the United States District
Court for the Southern District of New York, and hereby further irrevocably and unconditionally
waive and agree not to plead or claim in any such court that any such action, suit or proceeding
brought in any such court has been brought in an inconvenient forum.

          (d) Each party hereto further agrees that service of any process, summons, notice or document
by registered mail to its address set forth below shall be effective service of process for any
action, suit or proceeding brought against it under this Agreement in any such court.

     12.2 Notices. All notices, including notices of address change, required or permitted to be
given under this Agreement shall be in writing and deemed to have been received (a) if hand
delivered, on the day of personal delivery, (b) if delivered by FedEx or other reputable
international courier service, on the day of attempted or successful delivery to the other party
as confirmed by the courier service, or (c) if sent by confirmed facsimile transmission, on the
day after such transmission, in each case addressed to the address set forth below:

	 	 	 
	If to Medarex:

	 	Medarex, Inc.
	 

	 	707 State Road #206
	 

	 	Princeton, NJ 08540
	 

	 	_U.S.A.
	 

	 	Attn: President
	 

	 	Fax No.: (609) 430-2850
	 
	 	 
	With a copy to:

	 	Medarex, Inc.
	 

	 	707 State Road #206
	 

	 	Princeton, NJ 08540
	 

	 	U.S.A.
	 

	 	Attn: General Counsel
	 

	 	Fax No.: (609) 430-2850
	 
	 	 
	IftoIDM:

	 	IDMS.A.
	 

	 	172 rue de Charonne
	 

	 	75011 Paris, France
	 

	 	Attn: President
	 

	 	Fax No.:+33 1 40 09 04 25
	 
	 	 
	With a copy to:

	 	IDM S.A,
	 

	 	172 rue de Charonne
	 

	 	75011 Paris, France
	 

	 	Attn: Legal Counsel
	 

	 	Fax No.:+33 1 40 09 04 25

26

 

12.3 Nonassignability; Binding on Successors.

          (a) Without the prior written consent of the other party hereto, neither party shall sell,
transfer, assign, delegate, pledge or otherwise dispose of, whether voluntarily, involuntarily,
by operation of law or otherwise, this Agreement or any of its rights or duties hereunder;
provided, however, that either party hereto may assign or transfer this Agreement or any of its
rights or obligations hereunder without the consent of the other party (i) to any Affiliate of such
party; or (ii) to any third party with which it merges or consolidates, or to which it transfers
all or substantially all of its assets to which this Agreement relates if in any such event (1) the
assigning party (provided that it is not the surviving entity) remains jointly and severally liable
with the assignee, and (2) the assignee or surviving entity assumes in writing all of the assigning
party’s obligations under this Agreement. Any purported assignment or transfer in violation of this
Section shall be void ab initio and of no force or effect.

          (b) Medarex shall have the right to subcontract with a third party to manufacture the
Antibody for IDM, provided that Medarex shall continue to be liable for the performance of this
Agreement as if such manufacture was performed by Medarex.

     12.4 No Benefit to Third Parties. The representations, warranties, covenants and agreements
set forth in this Agreement are for the sole benefit of the parties hereto and their permitted
successors and assigns, and they shall not be construed as conferring any rights on any other
parties.

     12.5 Relationship of the Parties. It is expressly agreed that the parties shall be
independent contractors of one another and that the relationship between the parties shall not
constitute a partnership, joint venture or agency. Neither party shall have the authority to make
any statements, representations or commitments of any kind, or to take any action, which shall be
binding on the other, without the prior written consent of the other to do so. All persons
employed by a party shall be employees of such party and not of the other party and all costs and
obligations incurred by reason of any such employment shall be for the account and expense of such
party.

     12.6 Force Majeure. Neither party shall be held liable or responsible to the other party or be
deemed to have defaulted under or breached this Agreement for failure or delay in fulfilling or
performing any term of this Agreement when such failure or delay is caused by or results from
events beyond the reasonable control of the non-performing party, including fires, floods,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not),
insurrections, riots, civil commotion, strikes, lockouts or other labor disturbances, acts of God
or acts, omissions or delays in acting by any governmental authority. The non-performing party
shall notify the other party of such force majeure within ten (10) days after such occurrence by
giving written notice to the other party stating the nature of the event, its anticipated duration,
and any action being taken to avoid or minimize its effect. The suspension of performance shall be
of no greater scope and no longer duration than is necessary and the non-performing party shall use
commercially reasonable efforts to remedy its inability to perform.

27

 

     12.7 Compliance with Laws; Export Controls.

          (a) Subject to the provisions of Section 10, each party shall use reasonable efforts to
furnish to the other party any information reasonably requested or required by that party during
the term of this Agreement or any extensions hereof to enable that party to comply with the
requirements of any federal, state and/or government agency in the United States or European Union.

          (b) IDM agrees that it shall take all actions necessary to ensure compliance with all U.S.
laws, regulations, orders or other restrictions on exports and further shall not sell, license or
re-export, directly, or indirectly, products containing the Antibody to any person or entity for
sale in any country or territory, if, to the knowledge of IDM based upon reasonable inquiry, such
sale, would cause the parties to be in violation of any such laws or regulations now or hereafter
in effect. IDM agrees to secure from any recipient of products containing the Antibody adequate
manually signed written assurances prior to shipment from the United States as are required by the
U.S. export regulations.

     12.8 Severability. If any provision of this Agreement is found by a court of competent
jurisdiction to be unenforceable, then such provision shall be construed, to the extent feasible,
so as to render the provision enforceable, and if no feasible interpretation would save such
provision, it shall be severed from the remainder of this Agreement. The remainder of this
Agreement shall remain in full force and effect, unless the severed provision is essential and
material to the rights or benefits received by either party. In such event, the parties shall
negotiate, in good faith, and substitute a valid and enforceable provision or agreement that most
nearly implements the parties’ intent in entering into this Agreement.

     12.9 Waiver. Any term or condition of this Agreement may be waived at any time by the party
that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in
a written instrument duly executed by or on behalf of the party waiving such term or condition. The
waiver by either party hereto of any right hereunder or of the failure to perform or of a breach by
the other party shall not be deemed a waiver of any other right hereunder or of any other breach or
failure by said other party whether of a similar nature or otherwise.

     12.10 Use of Name. No right, express or implied, is granted by this Agreement to either party
to use in any manner the name of the other or any other trade name or trademark of the other in
connection with the performance of this Agreement.

     12.11 Construction.

          (a) This Agreement has been written and executed in the English language. Any translation into
any other language shall not be an official version thereof, and in the event of any conflict in
interpretation between the English version and such translation, the English version shall control.

          (b) Except where the context otherwise requires, wherever used, the singular shall include the
plural, the plural the singular, the use of any gender shall be applicable to all genders and the
word “or” is used in the inclusive sense (and/or). The term “including” as used

28

 

herein shall mean including, without limiting the generality of any description preceding
such term.

          (c) The captions of this Agreement are for convenience of reference only and in no way define,
describe, extend or limit the scope or intent of this Agreement or the intent of any provision
contained in this Agreement.

          (d) Medarex and IDM have each consulted counsel of their choice regarding this Agreement. The
language of this Agreement shall be deemed to be the language mutually chosen by the parties and no
rule of strict construction shall be applied against either party hereto.

     12.12 Entire Agreement; Amendments. This Agreement and the Exhibits attached hereto and
incorporated herewith, constitute the entire, final, complete and exclusive agreement between the
parties with respect to the Antibody and the research and development program to be performed by
Medarex and to be funded by IDM pursuant to Section 3.3 of the Technology Access Agreement and the
letter agreement attached hereto as Exhibit D, and all previous agreements or representations,
written or oral, with respect thereto are superseded hereby, merged and canceled and are null and
void. This Agreement may not be modified or amended except in a writing signed by a duly authorized
representative of each party.

     12.13 Counterparts. This Agreement may be executed in counterparts with the same force and
effect as if each of the signatories had executed the same instrument.

[Rest of page intentionally left blank]

29

 

In Witness Whereof, Medarex and IDM have executed this Agreement by

their respective duly authorized representatives as of the Effective Date.

	 	 	 	 	 	 	 	 	 
	Medarex, Inc.	 	IDM S.A.	 	 
	 
	 	 	 	 	 	 	 	 
	BY:

	 	/s/ Ronald A. Pepin
	 	BY:
	 	/s/ Bernard C. Brigonnet	 	 
	 

	 	 
	 	 	 	 	 	 
	Print Name: Ronald A. Pepin	 	Print Name: Bernard C. Brigonnet	 	 
	 
	 	 	 	 	 	 	 	 
	Title: Senior Vice President	 	Title: Executive Vice President and	 	 
	 

	 	Business Development
	 	 	 	Chief Operating Officer	 	 

30

 

Exhibit A

Indications

[...***...]

Exh. A-l

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

31

 

Exhibit B

Antibody Specifications and Test Methods

[Exhibit begins on following page.]

32

 

MEDAREX

[...***...]

	 	 	 	 	 	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 
	[...***...]

	 	[...***...]
	 	[...***...]	 	 

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

33

 

Exhibit C

Milestones

Within thirty (30) days following the occurrence of the relevant events specified below, with
respect to each Product for which a milestone event described below is achieved, IDM shall pay to
Medarex the following amounts:

	 	 	 	 	 	 	 
	Milestone Event	 	Milestone Payment
	 	1.	 	 	Upon approval of the first BLA, or equivalent in the United States

	 	[...***...]
	 	 	 	 	 
	 	 
	 	2.	 	 	Upon approval of the first MAA, or equivalent in the European
Union

	 	[...***...]
	 	 	 	 	 
	 	 
	 	3.	 	 	Upon approval of the first MAA, or equivalent in Japan

	 	[...***...]

If a separate BLA/MAA is filed for each Product Component, the above milestone events shall be
deemed achieved upon the filing or approval of the BLA/MAA of the second Product Component.

At IDM’s sole discretion, the milestone payments shall be paid in one of the following methods: (1)
in U.S. dollars by wire transfer in immediately available funds to an account designated by
Medarex; (2) if IDM is a private company on the date the milestone payment obligation accrues (the
“Payment Date”), in shares of IDM common stock having a value equal to the last price at which IDM
issued shares to an institutional or venture capital investor prior to the Payment Date; or (3) if
IDM is a public company on the Payment Date, in shares of IDM common stock having a fair market
value equal to the average closing sale price for the last ten (10) trading days prior to the
Payment Date.

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

34

 

Exhibit D

Letter Agreement

[Exhibit begins on following page.]

35

 

	707 Slate Road
Princeton O854O-1437
609-430-2880 Fax: 609-430-2850

July 30,2001

Jean-Loup Romet-Lemonne

President and CEO

IDM

172 rue de
Charonne

Paris France

Dear Jean-Loup,

Thanks far sending the research proposal and anticipates manufacturing requirements. Here is
what I propose : (1) We both expect            the research work called for in Section 3.3 of the
IDM-Medarex agreement will be completed within two years of the date of the original
contract, (2) this research work has already commenced, based upon numerous joint research
planning meeting and conference calls, (3) the research work will consist of technology
transfer-relating to the licensed products, certain clinical expenses relating to MDX-447
plus MAK in bladder cancer, and a scientific collaboration on Dendritic Cell Targeting,
generally as being discussed by our respective research teams.

To date, research work and technology transfer described in (3) above will include (a)
[...***...].

If this letter accurately represents our mutual understanding, please acknowledge by
signing at the bottom and returning a copy to me.

With best wishes,

Sincerely yours,

MEDAREX, INC.

/s/ Donald
L. Drakeman

By Donald L. Drakeman

vSA

/s/
[ILLEGIBLE]

	 	 	 	 	 
	 

	 	*
	 	Confidential Treatment Requested
	 

	 	 	 	under 17 C.F.R. §§200.80(b)(4) and 
	 

	 	 	 	240.24b-2(b)(1)

36

 

An extra section break has been inserted above this paragraph. Do not delete this section
break if you plan to add text after the Table of Contents/Authorities. Deleting this break will
cause Table of Contents/Authorities headers and footers to appear on any pages following the Table
of Contents/Authorities.

37

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