EXHIBIT 10.61
***Text Omitted and Filed Separately
Confidential Treatment Requested
Under 17 C.F.R. §200.80(b)(4) and
240.24b-2(b)(1)
AMENDED AND RESTATED IL-13
LICENSE AGREEMENT
BY AND
BETWEEN THE UNDERSIGNED :
IDM, a French
société anonyme with a capital of 1 569 444,60 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 CEO (hereinafter,
“IDM”).
SANOFI-AVENTIS,
a French société anonyme with a capital of 2 791 376 578
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 395 030 844, represented by Jean-Pierre
KERJOUAN, Advisor to the President and General Counsel, and
Mr. Jean-Claude MULLER, Senior Vice President Scientific and
Medical Operations Administration and Ressources (hereinafter
“SANOFI-AVENTIS”);
IDM and
SANOFI-AVENTIS being referred to hereinafter individually as «
a Party » or jointly as « the Parties ».
PRELIMINARY CONSIDERATIONS:
SANOFI-AVENTIS
has designed and development a cytokine known as Interleukin IL-13
(or IL-13) for which it has applied for patents and developed
knowhow;
For its part,
IDM has acquired and developed substantial knowhow and is the
holder of patents and relative patent applications, in particular
for ex vivo cancer therapies, marketed in the form of research kits
and cell processors.
On
July 13, 1999, the Parties executed an agreement, which was
cancelled and replaced by an amendment dated November 30, 2001
(hereinafter, the “IL-13 Agreement”), defining the
conditions under which SANOFI-AVENTIS granted IDM a non-exclusive
license to its IL-13 Industrial Property rights for the
implementation of Phase I and II Studies on one or more IL-13
Products and the marketing of IL-13 Research Kits in return for
SANOFI-AVENTIS’ taking a stake in the capital of
IDM.
This amendment
dated November 30, 2001 was further amended by amendment
number 1 dated March 30, 2005, both amendments being
collectively called the “IL-13 Agreement”.
The Parties
also entered into a Memorandum of Agreement on July 20, 2001,
pursuant to which SANOFI-AVENTIS has, on the terms and conditions
defined in such Memorandum of Agreement, a right of first refusal
to all IDM development
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programs in the
field of ex vivo cell therapy in humans, whether or not they
pertain to IL-13 (hereinafter, the “2001
Agreement”).
Pursuant to
provisions of article 8.2 of the IL-13 Agreement and pursuant to
information received from IDM related to the change of control of
IDM that will result from the announced combination between IDM and
Epimmune Inc., SANOFI-AVENTIS notified IDM of its decision to
proceed with an early exercise of BSA1 and BSA2 warrants, such
notification being equivalent to exercise of Option 1 and Option 2
(as defined in the IL-13 Agreement).
Option 1 and
Option 2 being therefore exercised pursuant to provisions of the
IL-13 agreement, both Parties must therefore enter into the IL-13
License Agreement and the Amendment to the IL-13 License Agreement
as annexed to the IL-13 Agreement. For the sake of simplicity, both
Parties agreed to enter into the Amended and Restated License
Agreement in order to benefit from a single document that includes
all provisions of the IL-13 License Agreement and the Amendment to
the IL-13 License Agreement, after removal of several provisions
that are now obsolete.
THE
PARTIES HEREBY COVENANT AS FOLLOWS:
Unless
otherwise specified in this IL-13 License Agreement, capitalized
words used in this IL-13 License Agreement or words printed in
capital letters have the meaning assigned to them in the IL-13
Agreement.
For the benefit
of this Agreement, an updated description of the IL-13 patents as
of the execution date is included in Annex 1. Such description
cancels and replaces the description included in annex 1.10 of the
IL-13 Agreement.
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2.1
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License grant
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As
a complement to the rights granted to IDM pursuant to the IL-13
Agreement, SANOFI-AVENTIS hereby grants to IDM, in the Territory, a
non-exclusive IL-13 Intellectual Property license for (i) the
performance of Phase III Studies for any IL-13 Development Program,
for (ii) the marketing of the IL-13 Research Kits, and
(iii) for the marketing of Final IL-13 Products. A list of the
IL-13 Development Programs currently ongoing is attached in Annex 2
to this Agreement.
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2.2
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Transfer of IL-13 Know-how and
additional elements of information
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The
Parties hereby acknowledge that all IL-13 Know-how and additional
elements of information licensed by SANOFI-AVENTIS under this
License
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2
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Contract, have already been
transferred to IDM in application of the IL-13
Agreement.
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2.3
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IL-13 supply of IDM
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The
conditions under which IL-13 shall be supplied to IDM are defined
in Article 3 of the IL-13 Agreement.
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ARTICLE 3
– IMPLEMENTATION OF THE IL-13 DEVELOPMENT
PROGRAMS
Except for
SANOFI-AVENTIS IL-13 Development Programs that are governed by the
2001 Agreement, and as a complement to IDM’s obligations
under the IL-13 Agreement :
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IDM
agrees to conduct, and bear all costs related to Phase III Studies
of the IL-13 Development Programs and use its best efforts to
complete these Phase III Studies in the best possible time frame
compatible with applicable legal and regulatory
requirements.
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IDM
shall provide SANOFI-AVENTIS with semi-annual progress reports on
the Phase III Studies and shall inform SANOFI-AVENTIS as soon as
possible of any problem likely to have a significant negative
impact on such Phase III Studies.
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Representatives of IDM and
SANOFI-AVENTIS shall meet at the request of one or the other Party
to discuss the contents of the semi-annual progress reports on the
Phase III Studies submitted by IDM. In the course of these
meetings, IDM shall provide all additional information that
SANOFI-AVENTIS might reasonably request on the results of the Phase
III Studies, provided this additional information is available on
the date of the SANOFI-AVENTIS request and does not require
additional research or investigations over and above those carried
out by IDM.
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IDM
shall provide SANOFI-AVENTIS with a summary report on the results
of the Phase III Studies conducted on one or more IL-13 Products,
within sixty (60) days following completion of these Phase III
Studies.
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4.1
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Fixed compensation
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4.1.1.
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In
consideration of the rights granted by SANOFI-AVENTIS to IDM under
this Agreement for conducting Phase III Studies for any IL-13
Development Programs and the marketing of IL-13 Research Kits, IDM
shall pay SANOFI-AVENTIS a sum equal to [...***...] before taxes.
IDM shall pay SANOFI-AVENTIS the corresponding amount of VAT if
applicable, within
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*
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Confidential Treatment
Requested
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under 17 C.F.R.
§§ 200.80(b)(4) and
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240.24b-2(b)(1)
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3
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thirty (30) days of the receipt
of the corresponding invoice, by bank transfer to the account
indicated on said invoice.
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By
express agreement between the Parties, pursuant to Article 7
of the IL-13 Agreement, this amount shall be paid by IDM provided
that it can be offset against an equal amount owed by
SANOFI-AVENTIS to IDM for the shares subscribed through the
exercise of BSA 1 warrants on the date of the offset.
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4.1.2.
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In
consideration of the rights granted by SANOFI-AVENTIS to IDM under
this Agreement for the Marketing of Final IL-13 Products, IDM shall
pay to SANOFI-AVENTIS a sum equal to [...***...] before taxes. IDM
shall pay SANOFI-AVENTIS the corresponding amount of VAT, if
applicable, within thirty (30) days following receipt of the
corresponding invoice, by bank transfer to the account indicated on
the invoice.
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By
express agreement between the Parties, pursuant to Article 7
of the IL-13 Agreement, this amount shall be paid by IDM provided
that it can be offset against an equal amount owed by
SANOFI-AVENTIS to IDM for the shares subscribed through the
exercise of BSA 2 warrants on the date of the offset.
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4.2.
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Royalties on sales
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In
consideration of the right granted by SANOFI-AVENTIS to IDM to
market IL-13 Products and IL-13 Research Kits, IDM shall pay
SANOFI-AVENTIS a royalty equal to [...***...] of the Net Sales
volume acheived by IDM in connection with this marketing. Net Sales
acheived by SANOFI-AVENTIS as an IDM licensee in application of the
2001 Agreement shall not be included in the Net Sales
base.
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IDM
shall maintain a special set of books, with the corresponding
supporting documentation, including all elements necessary for
calculating the amount payable by IDM to SANOFI-AVENTIS pursuant to
the provisions above. SANOFI-AVENTIS may cause these books to be
verified, at its simple request made with sufficient advance
notice, by an independent expert chosen jointly by the Parties and,
absent an agreement within fifteen (15) days of the date on
which SANOFI-AVENTIS 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 his best efforts to notify
his findings within a period of thirty (30) days after
referral of the case. The findings of this expert shall be final
and without recourse. The expert’s fees and costs will be
paid by SANOFI-AVENTIS except if the total amount owed by IDM to
SANOFI-AVENTIS is more than five per cent (5%) greater than the
amount reported by IDM, in which case these costs and fees shall be
paid by IDM.”
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ARTICLE 5
– LIABILITY / INSURANCE
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*
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Confidential Treatment
Requested
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under 17 C.F.R.
§§ 200.80(b)(4) and
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240.24b-2(b)(1)
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5.1.
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Without prejudice to the provisions
of common law, IDM shall assume any responsibility that might arise
from the implementation of the IL-13 Development Programs, as well
as from the exploitation of the results, vis-à-vis any Third
Party and on any basis whatsoever, and in particular 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 the IL-13 shipped by SANOFI-AVENTIS and not
manufactured in accordance with “Good Manufacturing
Practices”).
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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.
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IDM
shall also hold SANOFI-AVENTIS harmless with regard to any harmful
consequences that might arise for SANOFI-AVENTIS from any action
brought against SANOFI-AVENTIS by a Third Party based on damage of
any kind whatsoever resulting from the circumstances indicated
above.
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IDM
warrants that it has taken out, at its sole expense, the necessary
insurance coverage on terms and conditio
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