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Exhibit 10.19
LICENSE AGREEMENT
This License Agreement (the "AGREEMENT") is entered into and
made
effective the 31 day of January, 2005 (the "EFFECTIVE DATE")
between UNIVERSITY
OF MIAMI and its School of Medicine, whose principal place of
business is at
1600 N.W. 10th Avenue, Miami, Florida 33136 (hereinafter
referred to as
"LICENSOR") and Somaxon Pharmaceuticals, Inc., whose principal
place of business
is at 12750 High Bluff Drive, Suite 310, San Diego, California
92130
(hereinafter referred to as "LICENSEE").
WITNESSETH
WHEREAS, LICENSOR owns United States Patent Number 5,852,032
entitled "Method of Treating Nicotine Dependence"; and
WHEREAS, LICENSOR warrants that it possesses the right to
license
the subject patent and the right to market the Patent Rights;
and,
WHEREAS, LICENSEE desires to acquire an exclusive license in
the
License Territory (as defined in Section 1.7 below) for the
following use: human
treatment of nicotine dependence, with the right to sublicense,
under the Patent
Rights (as defined in Section 1.12 below) and Know-How (as
defined in Section
1.6 below) for the purposes of making, having made, using,
selling, having sold,
offering for sale, importing or otherwise commercializing
products and
practicing the invention disclosed and claimed in the Patent
Rights;
NOW THEREFORE, for these and other valuable considerations,
the
receipt of which is hereby acknowledged, the parties agree as
follows:
1. DEFINITIONS:
1.1 "AFFILIATE" shall mean any corporation or other business
entity
controlled by, controlling or under common control with LICENSOR
or LICENSEE.
For this purpose, "control" shall mean direct or indirect
beneficial ownership
of at least a fifty percent (50%) of the voting stock of, or at
least a fifty
percent (50%) interest in the income of such corporation or
other business
entity, or such other relationship as in fact, constitutes
actual control.
CERTAIN MATERIAL (INDICATED BY AN ASTERISK) HAS BEEN OMITTED
FROM THIS DOCUMENT
PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT. THE OMITTED
MATERIAL HAS BEEN
FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
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1.2 "FIELD OF USE" shall mean human treatment of nicotine
dependence, nicotine addiction and/or tobacco smoking.
1.3 "FORCE MAJEURE EVENT" shall mean events beyond the
reasonable
control of either party, including, but not limited to, war,
terrorism, riot,
strikes, boycotts, seizure, allocation, requisition, or any
further official
action by any department, bureau, board, administration, or
other
instrumentality or agency.
1.4 "GENERIC ENTRY DATE" shall mean the date of first regulatory
or
marketing approval in the Net Sales Territory of a generic
equivalent to any
Product, including, but not limited to, a product covered by an
Abbreviated New
Drug Application (ANDA) which references the initial New Drug
Application (NDA)
filed by LICENSEE or a sublicensee for such Product.
1.5 "GOVERNMENT" shall mean the United States federal
government.
1.6 "KNOW-HOW" shall mean trade secrets, inventions, data,
processes, procedures, devices, methods, formulas, protocols,
information and
other know-how, whether or not patentable, which is owned or
controlled by
LICENSOR during the License Term and is necessary or useful for
the commercial
exploitation of the Patent Rights.
1.7 "LICENSE TERRITORY" shall mean worldwide.
1.8 "METHOD" shall mean any method or process which is covered
in
whole or in part by an issued or unexpired claim contained in
the Patent Rights
or otherwise incorporating the Know-How.
1.9 "NET SALES" shall mean the sum of all amounts invoiced
on
account of sale or use of Products by LICENSEE and its
Affiliates and any
Sublicensees to non-affiliated third party purchasers or users
of Products, less
(a) [***], (b) [***], (c) [***], (d) [***] (e) [***].
1.10 "NET SALES TERRITORY" shall mean the United States of
America.
1.11 "PATENT EXPIRATION DATE" shall mean the last to expire of
the
Patent Rights.
1.12 "PATENT RIGHTS" shall mean United States Patent Number
5,852,032 of Mason issued December 22, 1998 entitled "Method of
Treating
Nicotine Dependence" and all divisions, renewals,
continuations,
continuations-in-part, reissues, extensions and substitutions
thereof and, to
the extent applicable, all foreign counterparts.
*** Certain information on this page has been omitted and filed
separately with
the Commission. Confidential treatment has been requested with
respect to the
omitted portions.
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1.13 "PRODUCT" shall mean any product or part thereof:
(a) the manufacture, use or sale or other commercialization
of
which is covered in whole or in part by an issued or
unexpired
claim contained in the Patent Rights or otherwise
incorporating the Know-How; or
(b) which is administered by using a Method.
1.14 "SUBLICENSEE" shall mean any third party to whom LICENSEE
has
granted a sublicense of LICENSEE's rights hereunder, provided
said third party
has agreed in writing with LICENSEE to accept the conditions and
restrictions
agreed to by LICENSEE in this Agreement.
2. GRANT:
2.1 In consideration for payment of royalties, LICENSOR
hereby
grants to LICENSEE an exclusive (even as to LICENSOR except as
specified in
Secantion 2.2 below) license, subject to any rights of the
Government, in the
License Territory, for the Field of Use, with the right to
sublicense, under the
Patent Rights and Know-How, to make, have made, use, sell, have
sold, offer for
sale, import or otherwise commercialize the Product and to
practice the Method.
2.2 LICENSOR retains the right to practice such invention for
its
own internal non-commercial, educational and research use.
3. TERM:
The license granted in this Agreement shall be Exclusive in the
Field of
Use until the later of (i) the Patent Expiration Date or (ii)
the date described
in Section 8.1(c)(ii) (the "LICENSE TERM"), unless terminated
earlier as
provided herein, and commencing as of the Effective Date of this
Agreement.
4. UNITED STATES LAWS:
4.1 LICENSEE understands that the Patent Rights may have
been
developed under a funding agreement with the Government and, if
so, that the
Government may have certain rights relative thereto. This
Agreement is
explicitly made subject to the Government's rights under any
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agreement and any applicable law or regulation. If there is a
conflict between
this Agreement and an agreement between LICENSOR and the
Government, applicable
law or regulation, the terms of the agreement between LICENSOR
and the
Government, applicable law or regulation, respectively, shall
prevail.
Specifically, this Agreement is subject to all of the terms and
conditions of
Title 35 United States Code sections 200 through 204, including
an obligation
that Product sold or produced in the United States be
"manufactured
substantially in the United States," and LICENSEE agrees to take
all reasonable
action necessary on its part as licensee to enable LICENSOR to
satisfy its
obligation thereunder, relating to the Patent Rights.
4.2 It is understood that LICENSOR is subject to United States
laws
and regulations controlling the export of technical data,
computer software,
laboratory prototypes and other commodities (including the Arms
Export Control
Act, as amended and the Export Administration Act of 1979), and
that its
obligations hereunder are contingent on compliance by LICENSEE
with applicable
United States export laws and regulations. The transfer of
certain technical
data and commodities may require a license from the cognizant
agency of the
United States Government and/or written assurances by LICENSEE
that LICENSEE
shall not export data or commodities to certain foreign
countries without prior
approval of such agency. LICENSOR neither represents that a
license from an
agency of the Government shall not be required nor that, if
required, it shall
be issued.
5. PATENT PROTECTION AND INFRINGEMENT:
5.1 LICENSOR, during the License Term, is responsible for
the
maintenance of all Patent Rights. LICENSEE shall reimburse
LICENSOR for all
payments made by LICENSOR in respect of the Patent Rights within
thirty (30)
days of LICENSEE's receipt of the applicable invoice.
5.2 LICENSEE shall promptly notify LICENSOR in writing of any
claim
of Patent Rights infringement which, to LICENSEE's knowledge, is
asserted
against LICENSEE or LICENSOR, its Affiliates and any
sublicensees because of the
manufacture, use, promotion and sale of Products.
5.3 Upon learning of any infringement of Patent Rights by
third
parties in any country, LICENSEE and LICENSOR will promptly
inform each other,
as the case may be, in writing
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of that fact and will supply the other with any available
evidence pertaining to
the infringement. LICENSEE, at its own expense, shall have the
option to take
whatever steps are necessary to stop the infringement at its
expense and recover
damages therefore, and will be entitled to retain all damages so
recovered. In
the event that LICENSOR and LICENSEE mutually agree to bring
suit, costs and
expenses shall be shared equally and any recovery in excess of
expenses shall be
shared equally. Each of the parties shall assist and cooperate
with the other
party in connection with any such suit or other action relating
to infringement.
In any event, no settlement, consent, judgment or other
voluntary final
disposition of the suit may be entered into without the consent
of LICENSOR,
which shall not be unreasonably withheld. In the event LICENSEE
does not take
steps to stop the infringement within ninety days after notice
from LICENSOR
specifically requesting such action and referring to this
Section 5.3, LICENSOR
shall have the right to terminate the License Agreement. In
connection with any
such termination, all Patent Rights and Know-How will revert to
LICENSOR.
6. INDEMNIFICATION:
6.1 LICENSEE agrees to release, indemnify, defend and hold
harmless
the LICENSOR and its Trustees, officers, faculty, employees and
students against
any and all losses, expenses, claims, actions, lawsuits and
judgments thereon
(including attorney's fees through the appellate levels)
("DAMAGES") which may
be brought against LICENSOR, its Trustees, officers, faculty,
employees or
students as a result of or arising out of (a) any negligent act
or omission of
LICENSEE or its agents or employees, (b) the use, production,
manufacture, sale,
lease, consumption or advertisement by LICENSEE, its Affiliates
or their
sublicensees or any third party with whom LICENSEE has or enters
into an
agreement of any Patent Rights, Methods, Know-How, Product,
invention or
technology licensed under this Agreement, (c) the use of
LICENSEE's own
trademarks and tradenames relating to the Products, or (d) any
and all third
party claims of Patent Rights infringement which may be asserted
against
LICENSOR, and Affiliates because of the manufacture, use,
promotion and sale of
Products; provided, however, that such indemnification right
shall not apply to
any judgments and Damages to the extent directly attributable to
the negligence,
reckless misconduct, or intentional misconduct of a party
seeking
indemnification under this Section 6.1.
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6.2 LICENSOR agrees to release, indemnify, defend and hold
harmless
the LICENSEE and its officers, employees and Affiliates against
any and all
Damages which may be brought against LICENSEE or its officers,
employees or
Affiliates as a result of or arising out of any negligent act or
omission of
LICENSOR or its Trustees, officers, faculty, agents, employees
or other
Affiliates, provided, however, that such indemnification right
shall not apply
to any judgments and Damages to the extent directly attributable
to the
negligence, reckless misconduct, or intentional misconduct of a
party seeking
indemnification under this Section 6.2.
6.3 Promptly after receipt by a party seeking indemnification
under
this Section 6 (an "INDEMNITEE") of notice of any pending or
threatened claim
against it (an "ACTION"), such Indemnitee shall give written
notice to the party
to whom the Indemnitee is entitled to look for indemnification
pursuant to this
Section 6 (the "INDEMNIFYING PARTY") of the commencement
thereof, provided that
the failure so to notify the Indemnifying Party shall not
relieve it of any
liability that it may have to any Indemnitee hereunder. In case
any Action that
is subject to indemnification under this Section 6 shall be
brought against an
Indemnitee and it shall give written notice to the Indemnifying
Party of the
commencement thereof, the Indemnifying Party shall be entitled
to participate
therein and, if it so desires, to assume the defense thereof
with counsel
reasonably satisfactory to such Indemnitee and, after notice
from the
Indemnifying Party to the Indemnitee of its election to assume
the defense
thereof, the Indemnifying Party shall not be liable to such
Indemnitee under
this Section 6 for any fees of other counsel or any other
expenses, in each case
subsequently incurred by such Indemnitee in connection with the
defense thereof,
other than reasonable costs of investigation. Notwithstanding an
Indemnifying
Party's election to assume the defense of any such Action that
is subject to
indemnification under this Section 6, the Indemnitee shall have
the right to
employ separate counsel and to participate in the defense of
such Action. If an
Indemnifying Party assumes the defense of such Action, no
compromise or
settlement thereof may be effected by the Indemnifying Party
without the
Indemnitee's written consent, which consent shall not be
unreasonably withheld
or delayed, unless (A) there is no finding or admission of any
violation of law
or any violation of the rights of any Person and no effect on
any other claims
that may be made against the Indemnitee and (B) the sole relief
provided is
monetary damages that are paid in full by the Indemnifying
Party.
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6.4 This Agreement to reimburse and indemnify under the
circumstances set forth above shall continue after the
termination of this
Agreement.
7. REPRESENTATIONS AND WARRANTIES:
7.1 Mutual Representations and Warranties.
(a) Each party represents and warrants that it is duly
authorized
to execute and deliver this Agreement and to perform its
obligations hereunder.
(b) Each party represents and warrants that this Agreement is
a
legal and valid obligation binding upon it and enforceable
in
accordance with its terms Each party represents that to the
best of its knowledge the execution, delivery and
performance
of this Agreement does not conflict with any agreement,
instrument or understanding, oral or written, to which it is
a
party or by which it may be bound, nor violate any law or
regulation of any court, governmental body or administrative
or other agency having jurisdiction over it.
7.2 REPRESENTATIONS AND WARRANTIES OF LICENSOR.
(a) LICENSOR represents and warrants that, subject to any
interest
of the Government, LICENSOR owns the Patent Rights and
Know-How and has sufficient rights and power to grant the
licenses to LICENSEE which LICENSOR purports to grant
herein.
(b) LICENSOR represents that, to the best of its knowledge,
except
as set forth in Section 4 above, there are no outstanding
liens, encumbrances, agreements or understandings of any
kind,
either written, oral or implied, regarding the Patent Rights
or Know-How which are inconsistent or in conflict with any
provision of this Agreement.
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(c) LICENSOR represents and warrants that it has no knowledge
of
any outstanding and unresolved claim or accusation that the
practice of the Patent Rights or Know-How infringes or may
infringe any third-party patent right(s).
(d) LICENSOR represents that, to the best of its knowledge,
no
patent application or patent within the Patent Rights or
Know-How is the subject of any interference, opposition,
cancellation or other protest proceeding.
7.3 Disclaimer of Other Warranties. Except as set forth in
Sections
7.1 and 7.2 above, LICENSOR MAKES NO WARRANTIES, EXPRESS OR
IMPLIED, AND HEREBY
DISCLAIMS ALL SUCH WARRANTIES, AS TO ANY MATTER WHATSOEVER,
INCLUDING, WITHOUT
LIMITATION, THE CONDITION OF ANY
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