Exhibit 10.52
***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, pursuant
to the Asset Purchase Agreement, Pharmexa has acquired IDM’s
entire right and title to PADRE ® ; and
WHEREAS, IDM
desires to obtain a license to PADRE ® and the related Licensed Patents and Licensed
Know-How, 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 “
Breach ” has the meaning set forth in
Section 8.2(b).
1.3 “
Cancer ” means 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.
1.4 “
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 PADRE ® .
1.5 “
Effective Date ” means the date of this Agreement
first written above.
1.6 “
Field ” means all Cancer indications other than
(i) indications covered by exclusive rights to use
PADRE ®
for Cancer indications previously
licensed by IDM (through its predecessor, Epimmune Inc.) to
Pharmexa A/S described in Schedule A and (ii) other
exclusive rights to use PADRE ® for Cancer indications granted by IDM to Third
Parties as described on Schedule A .
1.7 “ IDM
Cancer Product ” means a pharmaceutical product directed
exclusively for the treatment of Cancer that was conceived by IDM
and for which IDM makes substantive development efforts [. . . ***
. . .] . For the purpose of clarification, an IDM Cancer Product
shall not include (i) products conceived and/or developed [. .
. *** . . .] and (ii) products conceived by IDM but for which
no substantive efforts towards development are made by
IDM.
1.8 “
Indemnitee ” means a Person entitled to
indemnification pursuant to Article 7.
1.9 “
Indemnitor ” means a Person required to indemnify
another Person pursuant to Article 7.
1.10 “
Invention ” has the meaning set forth in
Section 4.4.
1.11 “
Licensed Know-How ” means 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, in each
case 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.
1.12 “
Licensed Patents ” means all Patents owned or
controlled by Pharmexa that relate to PADRE
® , including without limitation those listed on
Schedule B, and any abandoned parent applications of any
Patents listed therein.
1.13 “
Licensed Technology ” means the Licensed Patents and
Licensed Know-How.
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Confidential Treatment
Requested
under 17 C.F.R. §§
200.80(b)(4) and
240.24b-2(b)(1)
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1.14 “
PADRE ® ” or a pan-DR epitope or pan-DR peptide
means a family of proprietary molecules that are universal helper T
cell epitopes capable of binding antigen binding sites on major
histocompatibility complex (MHC) molecules encoded by
substantially all alleles of a DR locus, including, without
limitation, peptides claimed or disclosed in United Sates Patent
Application Serial No. 08/121,101 filed September 14,
1993 or any patent applications, such as continuing applications
(including, without limitation, any continuations,
continuations-in-part or divisional thereof) or patents issuing
therefrom. Such peptides are also referred to as pan DR binding
epitopes or peptides and include, without limitation, AKXVAAWTLKAAA
(using the single letter designation for amino acids), wherein X is
cyclohexylalanine or phenylalanine, and other peptides claimed
and/or disclosed in the Patents described in this
Section 1.13.
1.15 “
Parties ” means Pharmexa and IDM,
collectively.
1.16 “
Party ” means either Pharmexa or IDM, as the context
may require.
1.17 “
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.
1.18 “
Person ” means any individual, corporation,
partnership, limited liability company, private or public
institution, group, tribunal, government authority or other
entity.
1.19 “
Third Party ” means any Person other than IDM,
Pharmexa, or their respective Affiliates.
ARTICLE 2
. LICENSE GRANT .
(a) Pharmexa
hereby grants to IDM a non-exclusive, perpetual, royalty-free,
fully paid up, worldwide license, with the right to grant
sublicenses (subject to the limitations set forth in
Schedule 2.1(b)), under the Licensed Technology to research,
develop, make, have made, use, import, export, sell, offer for
sale, promote, market, distribute, commercialize, and have sold,
distributed and commercialized IDM Cancer Products in the Field
(the “ License ”).
(b) Notwithstanding
anything to the contrary set forth in this Agreement, IDM may not
grant sublicenses to, sell, or otherwise transfer its rights to the
Licensed Technology set forth in Section 2.1(a) other than in
connection with the sublicense, sale or transfer of an IDM Cancer
Product and as permitted pursuant to Section 10.4. Each such
sublicense granted by IDM will limit the sublicensee’s use of
the Licensed Technology to the development and commercialization of
the specific IDM Cancer Product that is the subject of the
sublicense.
2.2 Rights
Retained by Pharmexa . Notwithstanding anything to the contrary
herein, Pharmexa retains all rights under the Licensed Technology
not explicitly 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 the Licensed
Technology, not to exceed a total of [. . . *** . . .] per month,
up to a maximum of [. . . *** . . .] during the first year of this
Agreement and a maximum of [. . . *** . . .] during each succeeding
year.
ARTICLE 3
. CONSIDERATION FOR LICENSE .
3.1
Consideration . Pharmexa acknowledges and agrees that the
sole consideration for the grant of the License is the consummation
by IDM of the transactions contemplated by the Asset Purchase
Agreement. No other license fees, milestones, royalties or other
consideration shall be paid or given to Pharmexa by IDM for the
rights granted under this Agreement.
4.1 No
Assignment . The License shall not constitute an assignment of
the Licensed Technology, nor a grant to IDM of any ownership right
or title therein or any other right, other than the use of
PADRE ®
and practice of the Licensed
Technology 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 and have complete discretion in connection
with the preparation, filing, prosecution, defense and maintenance
of the Licensed Patents. Pharmexa shall keep IDM informed of all
material developments pertaining to the Licensed Patents and give
consideration to IDM’s recommendations and concerns regarding
the prosecution and maintenance of the Licensed Patents.
(b) Pharmexa
will pay all costs associated with the prosecution and maintenance
of the Licensed Patents.
(c) Pharmexa
shall not allow an issued 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
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*
Confidential Treatment
Requested
under 17 C.F.R. §§
200.80(b)(4) and
240.24b-2(b)(1)
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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 for such
assignment other than actual costs associated with such transfer,
and (ii) upon assignment, such Patent shall cease to be a
Licensed Patent. In such event, IDM will grant to Pharmexa a
non-exclusive, perpetual, royalty-free, fully paid up license under
such Patent, with the right to grant sublicenses to research,
develop, make, have made, use, import, sell, offer for sale,
promote, market, distribute, commercialize and have sold
pharmaceutical products in the country in which the Patent is
granted.
4.3
Infringement Actions .
(a) In
the event that a Party becomes aware of actual or threatened
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.
(b) Pharmexa
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 Pharmexa’s expense.
IDM will cooperate with Pharmexa at Pharmexa’s request in
connection with any such action. IDM will have the right to
participate in any legal action commenced by Pharmexa against the
Third Party through counsel of its own choosing at its expense,
provided that Pharmexa will control all elements of the prosecution
of the legal action against the Third Party, including all
decisions to enter into settlements, judgments or other
arrangements. In such case, the amount, if any, recovered in an
action against a Third Party found liable for infringing the
Licensed Patents, whether by judgment, award, decree or settlement,
shall be applied as follows: (i) first, to reimburse Pharmexa
for its legal fees and other litigation expenses incurred in
connection with the prosecution of such action; (ii) second,
to reimburse IDM for its legal fees and other litigation expenses
incurred in connection with the prosecution of such action; and
(iii) the balance shall be allocated among the Parties as they
shall [. . . *** . . .].
4.4
Inventions . Each Party shall promptly notify the other
Party in writing of any and all discoveries, inventions or
improvements that specifically pertain to PADRE
® ( or any part thereof) or methods of its
use conceived or reduced to practice by any employee or contractor
of such Party during the term of this Agreement (“
Inventions ”). Inventorship of Inventions shall be
determined in accordance with the rules of inventorship under
United States patent laws. All right, title and interest to any
Inventions made by IDM will be assigned to Pharmexa and Pharmexa
shall have the first right to file, prosecute and maintain Patents
on Inventions at its expense through counsel of its own choosing.
Any Patents on Inventions become Licensed Patents upon filing. With
respect to any Invention, if Pharmexa does not take steps to
prepare and file a patent application within [. . . *** . . .]
after disclosure of such Invention by either Party, or if it files
an application but subsequently elects to abandon such application,
IDM
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Confidential Treatment
Requested
under 17 C.F.R. §§
200.80(b)(4) and
240.24b-2(b)(1)
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shall have the
option to undertake such filing and/or prosecution and Pharmexa
shall provide such cooperation as IDM may request, at IDM’s
expense, including but not limited to delivering to the IDM all
records reasonably necessary for the filing and prosecution of the
patent application claiming or disclosing such Invention and
executing any and all documents as may be needed to assign such
Invention and patent application to the IDM, without additional
consideration being payable for such assignment, and upon
assignment such Patent shall cease to be a Licensed
Patent.
4.5
Infringement of Third Party Rights . If the sale of any
product by a Party is determined or alleged to infringe, or if a
party receives notice of or is sued for infringement of, a Patent
owned or licensed by a Third Party, the Parties shall meet to
discuss what action should be taken if such infringement claim is
based on the use of PADRE ® in the development, manufacture, sale or use of
the product. Each Party shall have the first right in its sole
discretion to control at its own expense the defense of all charges
of infringement by any Third Party arising as a result of its
development, manufacture, use, sale or commercialization of its
products. The other Party shall have the right to be represented by
counsel of its own selection, at such other Party’s own
expense, in any such action that may impact its rights to
PADRE ®
, and shall cooperate fully in the
defense of such suit, including furnishing to the other Party all
relevant evidence and assistance in its control. The Party
controlling the defense of any such infringement action may not
settle the action or otherwise consent to an adverse judgment in
such action if such settlement or judgment would diminish the
rights or interest of the other Party without the prior written
consent of the other Party, which consent shall not be unreasonably
withheld or delayed.
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ARTICLE 5
. CONFIDENTIALITY .
5.1
Confidentiality . The Parties acknowledge that in connection
with the license and rights granted under this Agreement, the
Parties may exchange Confidential Information. At all times during
the term of this Agreement and for a period of [. . . *** . . .]
thereafter, each Party shall keep the other Party’s
Confidential Information secret and confidential and not use the
other Party’s Confidential Information for any purpose other
than the exercise of the rights granted under this Agreement.
Notwithstanding the foregoing, each Party may disclose Confidential
Information to its employees, agents, consultants and sublicensees
in connection with its exercise of its rights under this Agreement,
provided that the recipient Party must obtain the prior written
agreement of all such employees, agents, consultants and
sublicensees to whom it may disclose the other Party’s
Confidential Information not to use or disclose such Confidential
Information for any purpose other than those purposes permitted by
this Agreement. Each Party agrees that it will take the same
measures to protect the confidentiality of the other Party’s
Confidential Information which it takes with respect to its own
confidential and proprietary information, but not less than
reasonable care. Each Party will promptly notify the other upon
discovery of any unauthorized use or disclosure of Confidential
Information. For the purpose of clarification, all confidential and
proprietary information regarding PADRE ® in IDM’s possession or control on or prior
to the Effective Date (excluding information specific to any IDM
Cancer Product derived through the use of PADRE
® , and which is not generally applicable to
PADRE ® itself) will be deemed by virtue of the
transactions consummated pursuant to the Asset Purchase Agreement
to be Confidential Information of Pharmexa.
5.2
Exceptions . The obligations of a Party receiving
Confidential Information from the other Party shall not apply to
any information to the extent it can be established by the
receiving Party by competent written proof that such information
(a) was in the public domain as of the Effective Date;
(b) becomes part of the public domain subsequent to the
Effective Date by publication or otherwise, except by breach of
Section 5.1 by the receiving Party or its employees, agents,
consultants or sublicensees; (c) is received by the receiving
Party from a Third Party that has the legal right to disclose such
information without restriction or (d) was independently
developed by employees of the receiving Party that did not have
access to or knowledge of the information disclosed by the
disclosing Party. Notwithstanding the foregoing, information in
IDM’s possession as of the Effective Date that is being
transferred to Pharmexa pursuant to the Asset Purchase Agreement
will not fall within the exceptions provided by clauses
(a) and (d). In addition, each Party may disclose Confidential
Information belonging to the other Par
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