***Text Omitted and Filed
Separately
Confidential Treatment Requested
Under 17 C.F.R. §§ 200.80(b)(4) and
240.24b-2(b)(1)
LICENSE AGREEMENT
dated December 30, 2005 by and between IDM Pharma, Inc., a
Delaware corporation (“ IDM ”), and Pharmexa,
Inc., a Delaware corporation (hereinafter “ Pharmexa
”) (each, a “ Party ” and, collectively,
the “ Parties ”).
WHEREAS, IDM and
Pharmexa have entered into an Asset Purchase Agreement dated
November 23, 2005 (the “ Asset Purchase Agreement
”);
WHEREAS, it is a
condition precedent to the consummation of the transactions
contemplated by the Asset Purchase Agreement that the Parties enter
into this Agreement;
WHEREAS, as a
result of the transactions contemplated by the Asset Purchase
Agreement, Pharmexa is the owner of the entire right and title to
EIS ®
and the Existing Library and related
Licensed Patents and Licensed Know-How (as such terms are defined
below, and subject to certain exclusions as defined herein);
and
WHEREAS, IDM
desires to obtain a license to EIS and the related Licensed Patents
and Licensed Know-How and the right to access and use the Existing
Library, and Pharmexa is willing to grant such license and right to
IDM, subject to the terms and conditions hereinafter set
forth;
NOW THEREFORE, in
consideration of the mutual covenants and agreements contained
herein, and intending to be bound, and it being understood that the
above recitals shall have the same value as the stipulations that
follow, the Parties hereby agree as follows:
ARTICLE 1
. CERTAIN DEFINITIONS .
As used in this
Agreement, each term listed below has the meaning which is given
after it:
1.1 “
Affiliate ” means, with respect to each Party, any
person, corporation or other business entity that controls, is
controlled by or is under common control with such Party, but for
only so long as such control exists. For the purpose of this
definition, “control” means the ability, directly or
indirectly, to vote or direct the vote of fifty percent (50%) or
more of the outstanding voting stock of an entity (or other form of
ownership interest with respect to an entity that is not a
corporation), or to otherwise direct or cause the direction of the
management and policies of an entity.
1.2 “
Antigen ” means any substance, including, without
limitation, proteins, toxins, viruses or bacteria, or portions of
any thereof, that is capable of stimulating the production of an
immune response.
1
1.3 “
AutoVac™ ” means Pharmexa’s therapeutic
vaccine technology for inducing a controlled therapeutic immune
response against self-Antigens that cause or are associated with
disease by introducing a modified Antigen consisting of a foreign
Epitope inserted into such a self-Antigen.
1.4 “
Cancer Field ” means the prevention or treatment of
any disease caused or characterized by an uncontrolled or abnormal
cell division or growth within any part of the body, irrespective
of cause or origin.
1.5 “
Confidential Information ” of a Party means any
confidential or proprietary information (including any technology,
know-how, Patent application, test result, research study, business
plan, budget, forecast or projection) relating directly or
indirectly to the business of such Party or any Affiliate,
predecessor or successor of such Party (whether prepared by such
Party or by any other person and whether or not in written form)
that is or has been made available to the other Party or any of its
Affiliates or representatives, including but not limited to
information related to EIS and the Existing Library.
1.6 “
Effective Date ” means the date of this Agreement
first written above.
1.7 “
EIS ® ” or “ Epitope Identification
System ” means proprietary methods of using sequence
information derived from an Antigen to identify and/or characterize
Antigen-specific Epitopes, to design vaccines, to identify Epitope
analogues, to identify optimal Epitope variants, and to design
Epitope minigene constructs, which methods are claimed or disclosed
in the Existing Patents as of the Effective Date.
1.8 “
Epitope ” means a molecular region of an Antigen,
which is involved in recognition by a particular immunoglobulin, or
in the context of T cells, by a T cell receptor and/or Major
Histocompatibility Complex (MHC) receptor.
1.9 “
Existing Library ” means the database comprising the
library of Epitopes existing as of the Effective Date, which
Epitopes are claimed or disclosed in the Existing Patents as of the
Effective Date.
1.10 “
Existing Patents ” means all Patents acquired by
Pharmexa pursuant to the Asset Purchase Agreement pertaining to
EIS, as listed on Schedule A, and any abandoned parent
applications of any Patents listed therein.
1.11 [. . . *** .
. .]” means the [. . . *** . . .] of the Effective
Date.
1.12 “
IDM Reserved Rights ” has the meaning set forth in
Section 2.1(a).
1.13 “
Infringement Notice ” has the meaning set forth in
Section 4.3(a).
1.14 “
Indemnitee ” means a Person entitled to
indemnification pursuant to Article 7.
1.15 “
Indemnitor ” means a Party required to indemnify a
Person pursuant to Article 7.
|
|
|
|
|
|
|
|
|
*
|
|
Confidential Treatment
Requested
under 17 C.F.R. §§
200.80 (b) (4)
and
240.24b-2 (b)
(1)
|
2
1.16 “
Invention ” has the meaning set forth in
Section 4.4.
1.17 “
Licensed Know-How ” mean all methods, procedures,
trade secrets, formulas, techniques, assays, protocols, procedures,
processes, systems, specifications, data, sequence information,
algorithms, computer models, results of clinical trials and
technical data owned or controlled by Pharmexa as of the Effective
Date or during the term of this Agreement, including any
Inventions, which are not included in the Licensed Patents, but
which are necessary or useful for the commercial exploitation of
the Licensed Patents and which are not generally publicly known,
including, without limitation, any such methods, procedures, trade
secrets, formulas, techniques, assays, protocols, procedures,
processes, systems, specifications, data, sequence information,
algorithms, computer models, results of clinical trials and
technical data assigned to Pharmexa by IDM under the Asset Purchase
Agreement that are necessary or useful for the commercial
exploitation of the Licensed Patents.
1.18 “
Licensed Patents ” mean (i) all Existing Patents,
and (ii) all Patents owned or controlled by Pharmexa that
claim or disclose any Invention conceived or reduced to practice by
any employee or contractor of Pharmexa.
1.19 “
Patents ” means all U.S. patents and patent
applications, including, without limitation, certificates of
invention and applications for certifications of invention,
registered designs and registered design applications, industrial
designs and industrial design applications and registrations,
reissues, reexaminations, extensions, substitutions, confirmations,
registrations, revalidations, renewals, term restorations,
additions, provisionals, continuations, continuations-in-part,
divisions, continued prosecution applications, and requests for
continued examination thereof, and any foreign equivalents of any
of the foregoing.
1.20 “
Person ” means any individual, corporation,
partnership, limited liability company, private or public
institution, group, tribunal, government authority or other
entity.
1.21 “
Pharmexa Field ” means the prevention or treatment of
any and all indications, including, but not limited to, infectious
diseases, inflammatory diseases, autoimmunity, neurologic disorders
and metabolic disorders, but excluding the Cancer Field.
1.22 “
Product ” means any product that incorporates or uses
all or any part of an Epitope identified using the Licensed Patents
or the Licensed Know-How or present in the Existing
Library.
1.23 “
Specific Product ” means any Product formulated as
(i) an AutoVac ä recombinant protein or DNA vaccine (as opposed
to peptide Epitopes) or (ii) a peptide product against one of
the following targets (or combinations thereof): [. . . *** . .
.]
1.24 “
Third Party ” means any Person other than IDM,
Pharmexa, or their respective Affiliates.
|
|
|
|
|
|
|
|
|
*
|
|
Confidential Treatment
Requested
under 17 C.F.R. §§
200.80 (b) (4)
and
240.24b-2 (b)
(1)
|
3
ARTICLE 2
. LICENSE GRANTS .
(a) Pharmexa
hereby grants to IDM (i) an exclusive (including as to
Pharmexa), perpetual, royalty-free, fully paid up, worldwide
license, with the right to grant sublicenses, under the Licensed
Patents and the Licensed Know-How to use all specific Epitopes in
the Existing Library which are contained in Products as to which
IDM has granted exclusive rights to Third Parties prior to the
Effective Date to the extent of the field(s) in which such rights
were granted or to which IDM grants exclusive rights to Third
Parties at any time on or after the Effective Date and prior to the
[. . . *** . . .] to research, develop, make, have made, use,
import, export, sell, offer for sale, promote, market, distribute,
commercialize, and have sold, distributed and commercialized
Products (other than Specific Products) in the fields within the
Cancer Field in which such rights were granted, (ii) a
non-exclusive, perpetual, royalty-free, fully paid up, worldwide
license, with the right to grant sublicenses, under the Licensed
Patents and the Licensed Know-How to use all specific Epitopes in
the Existing Library which are contained in Products as to which
IDM has granted non-exclusive rights to Third Parties prior to the
Effective Date to the extent of the field in which such rights were
granted or to which IDM grants non-exclusive rights to Third
Parties at any time on or after the Effective Date and prior to the
[. . . *** . . .] to research, develop, make, have made, use,
import, export, sell, offer for sale, promote, market, distribute,
commercialize, and have sold, distributed and commercialized
Products (other than Specific Products) in the fields within the
Cancer Field in which such rights were granted and (iii) an
exclusive (including as to Pharmexa), perpetual, royalty-free,
fully paid up, worldwide license, with the right to grant
sublicenses, under the Licensed Patents and the Licensed Know-How
to use each of the specific Epitopes in the Existing Library listed
on Schedule B-1 , individually and in combination, to
research, develop, make, have made, use, import, export, sell,
offer for sale, promote, market, distribute, commercialize, and
have sold, distributed and commercialized Products, excluding
Specific Products, in the Cancer Field (collectively, the “
IDM Reserved Rights ”). Schedule B-2 sets
forth for each Epitope in the Existing Library for which IDM has
granted rights to a Third Party: (i) the identity of the Third
Party; (ii) the specific Epitope for which rights were
granted; (iii) whether the rights granted to the Third Party
are exclusive or non-exclusive and (iv) the field in which the
Third Party may utilize the Epitope. With regard to each new final
agreement with Third Parties for Epitopes in the Existing Library
which IDM enters into after the Effective Date, IDM will provide
Pharmexa with prompt written notice of the specific Epitopes
subject to the IDM Reserved Rights setting forth the type of
information required in Schedule B-2 . IDM will
exercise the foregoing right to grant rights to Third Parties on or
after the Effective Date and prior to the [. . . *** . . .] only in
the ordinary course of IDM’s business consistent with
IDM’s past custom and practice and, in any event, only as a
grant of rights to access and use specific Epitopes in the Existing
Library. IDM will require that any Third Party to which IDM grants
rights in any specific Epitopes in the Existing Library on or after
the Effective Date and before the [. . . *** . . .] acknowledge in
writing that Pharmexa is the owner of such Epitopes and that such
Third Party will not bring any legal action against Pharmexa
arising solely from Pharmexa’s ownership of such
Epitopes.
|
|
|
|
|
|
|
|
|
*
|
|
Confidential Treatment
Requested
under 17 C.F.R. §§
200.80 (b) (4)
and
240.24b-2 (b)
(1)
|
4
(b) Pharmexa
hereby grants to IDM a non-exclusive, perpetual, royalty-free,
fully paid up, worldwide license, with no right to grant
sublicenses, under the Licensed Patents and the Licensed Know-How
to identify Epitopes using EIS and, subject to the IDM Reserved
Rights, to use Epitopes in the Existing Library for research in the
Cancer Field, excluding Specific Products.
(c) Pharmexa
hereby grants to IDM a perpetual, royalty-free, fully paid up,
worldwide license, with the right to grant sublicenses (which
sublicenses shall permit the further grant of sublicenses), under
the Licensed Patents and the Licensed Know-How to use all Epitopes
identified by or for IDM using EIS or contained in the Existing
Library to research, develop, make, have made, use, import, export,
sell, offer for sale, promote, market, distribute, commercialize,
and have sold, distributed and commercialized Products, excluding
Specific Products, in the Cancer Field, which license shall be
exclusive (including as to Pharmexa) from the Effective Date until
the [. . . *** . .
.] and shall be non-exclusive from and after the [. . . *** . . .],
in each case subject to the IDM Reserved Rights. For the purpose of
clarification, (i) the foregoing grant shall not prevent
Pharmexa from conducting any activity with respect to Specific
Products at any time and (ii) commencing on the [. . . *** . .
.], all restrictions on Pharmexa with respect to the Cancer Field
under this Section 2.1(c) shall terminate.
2.2. Rights
Retained by Pharmexa . Notwithstanding anything to the contrary
herein, Pharmexa retains all rights under the Licensed Patents and
Licensed Know-How not explicitly granted to IDM under
Section 2.1, and all rights under Licensed Patents and
Licensed Know-How with respect to any Epitopes in the Existing
Library and any Products using such Epitopes granted to
Innogenetics NV dated July 9, 2001, as amended. Prior to the
[. . . *** . . .], Pharmexa shall not grant any Third Party any
right, title or interest in the Existing Library, any of the
Epitopes contained in the Existing Library or any of the Licensed
Patents, that would conflict with the rights granted to IDM under
Section 2.1.
2.3 Reasonable
Access . Pharmexa will provide IDM with reasonable access to
appropriate personnel of Pharmexa via telephone, facsimile or
electronic mail during Pharmexa’s regular business hours in
order to discuss questions relating to the use of EIS, not to
exceed a total of [. . . *** . . .] per month.
2.4 Duplicate
Copies . IDM shall be entitled to retain a duplicate copy of
any written materials describing or containing Licensed Know-How in
existence as of the Effective Date and a duplicate copy of the
database in existence as of the Effective Date containing the
Existing Library and may update such database to include
information regarding Epitopes identified using EIS pursuant to the
licenses granted under Section 2.1, in each case for purposes
of practicing the licenses granted under
Section 2.1.
ARTICLE 3
. CONSIDERATION FOR LICENSE .
3.1
Consideration . Pharmexa acknowledges and agrees that the
sole consideration for the grant of the licenses pursuant to
Section 2.1 is the consummation by IDM of the
transactions contemplated by the Asset Purchase Agreement. No other
license fees, milestones, royalties or
|
|
|
|
|
|
|
|
|
*
|
|
Confidential Treatment
Requested
under 17 C.F.R. §§
200.80 (b) (4)
and
240.24b-2 (b)
(1)
|
5
other
consideration shall be paid or given to Pharmexa by IDM for the
rights granted under this Agreement.
4.1 No
Assignment . The grant of the licenses pursuant to
Section 2.1 shall not constitute an assignment of the
Licensed Patents or the Licensed Know-How, nor a grant to IDM of
any ownership right or title therein or any other right, other than
use of EIS and the Existing Library and practice of the Licensed
Patents and Licensed Know-How in accordance with the terms of this
Agreement. Nothing contained in this Agreement shall be construed
as conferring upon IDM by implication, estoppel or otherwise any
license or other rights under any Patent or unpatented technology
belonging to Pharmexa, except rights expressly granted hereunder to
IDM.
4.2 Patent
Filing, Prosecution and Maintenance .
(a) Pharmexa
shall be responsible for the preparation, filing, prosecution,
defense and maintenance of the Licensed Patents. Pharmexa shall
provide to IDM copies of all documents relating to such filing,
prosecution, defense and maintenance in sufficient time to permit
IDM to review such documents and comment thereon prior to filing.
Pharmexa will incorporate all reasonable written suggestions
provided by IDM to Pharmexa with respect to the content and
strategies for filing, prosecution, defense and maintenance of the
Licensed Patents.
(b) IDM
will reimburse Pharmexa for [. . . *** . . .] of all reasonable and
customary documented out-of-pocket costs, other than late filing
fees, incurred and paid by Pharmexa in connection with the
prosecution and maintenance of the Licensed Patents. Such costs
shall be paid by IDM on a [. . . *** . . .] after it receives a
written request for payment from Pharmexa accompanied by reasonable
documentary evidence confirming the expense incurred and paid by
Pharmexa during the [. . . *** . . .]. Notwithstanding the
foregoing, IDM shall not be under any obligation to reimburse
Pharmexa for costs incurred and paid by Pharmexa related to any
Patents that pertain to Epitopes identified by Pharmexa after the
Effective Date or that claim or disclose Inventions conceived or
reduced to practice by employees or contractors of Pharmexa. IDM
may terminate its rights under this Agreement with respect to any
specific Licensed Patent by giving written notice thereof to
Pharmexa, in which case, such Patent shall cease to be a Licensed
Patent and IDM will not be responsible under this Section 4.2
for any costs associated with such Patent incurred following the
date of notice of such termination by IDM to Pharmexa.
(c) Pharmexa
shall not allow a Patent included in the Licensed Patents to lapse
without providing prior written notice to IDM. In the event that
Pharmexa decides to abandon or discontinue the prosecution or
maintenance of any of the Licensed Patents, IDM shall have the
right to undertake such prosecution or maintenance in its own name
at its expense through counsel of its own choosing. If IDM exercise
such right, (i) Pharmexa shall provide such cooperation as IDM
may request, at IDM’s expense, including but not limited to
delivering to IDM all records pertaining to such Patent executing
any and all documents as may be needed to assign such Licensed
Patent to IDM, without additional consideration being payable by
IDM
|
|
|
|
|
|
|
|
|
*
|
|
Confidential Treatment
Requested
under 17 C.F.R. §§
200.80 (b) (4)
and
240.24b-2 (b)
(1)
|
6
for such
assignment other than actual costs associated with such transfer,
and (ii) upon assignment, such Patent shall cease to be a
Licensed Patent.
4.3
Infringement Actions .
(a) In
the event that a Party becomes aware of actual or threatened
material infringement by a Third Party of any of the Licensed
Patents anywhere in the world, such Party shall (i) promptly
notify the other Party in writing of the occurrence such
infringement and (ii) provide the other Party with the full
details of any such infringement to the best of its knowledge (the
“ Infringement Notice ”).
(b) If
any actual or threatened infringement by a Third Party of any of
the Licensed Patents anywhere in the world involves the research,
manufacture, sale, distribution or commercialization of products
solely within the scope of the IDM Reserved Rights in
Section 2.1(a)(i), IDM shall have the exclusive right to
commence a lawsuit to enjoin the infringing activity or take such
other action against the Third Party as it determines is
appropriate, at IDM’s expense. Pharmexa will cooperate in
such action and will have the right to participate in such action
at its own expense through counsel of its own choosing. In such
case, the entire amount, if any, recovered in such an action
against a Third Party , whether by judgment, award, decree or
settlement, shall be applied as follows: (i) first, to
reimburse IDM for its legal fees and other litigation expenses
incurred in connection with the prosecution of such action;
(ii) second, to reimburse Pharmexa for its legal fees and
other litigation expenses incurred in connection with the
prosecution of such action; and (iii) the balance shall go to
IDM.
(c) With
regard to any actual or threatened infringement by a Third Party of
any of the Licensed Patents anywhere in the world, other than as
described in Section 4.3(b) , Pharmexa shall have the
first right to commence a lawsuit to enjoin the infringing activity
or take such other action against the Third Party as it determines
is appropriate, at Pharmexa’s expense, through counsel of its
own choosing reasonably acceptable to IDM. If Pharmexa elects not
to undertake any such action or fails to do so within [. . . *** .
. .] after receipt or delivery, as applicable, of an Infringement
Notice from IDM, then IDM will have the right to commence a lawsuit
or take other action against the Third Party at its expense and
through counsel of its own choosing reasonably acceptable to
Pharmexa. Regardless of which Party initiates legal action against
the infringing Third Party, the non-initiating Party will cooperate
in such action and will have the right to participate through
counsel of its own choosing at such non-initiating Party’s
expense. The Party initiating the legal action will control all
elements of the prosecution of the legal action, including all
decisions to enter into settlements, judgments or other
arrangements; provided, however, that no settlement that affects
the rights of the non-initiating Party may be entered into without
that Party’s consent. The amount, if any, recovered in any
such action against a Third Party , whether by judgment, award,
decree or settlement, shall be applied as follows: (i) first,
to reimburse the Party conducting the prosecution of the
infringement action for its legal fees an
|