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EXHIBIT 10.14
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.
LICENSE AGREEMENT
THIS AGREEMENT made and entered
into this 3rd day of January, 2005 (" EFFECTIVE DATE "), by
and between OREXIGEN THERAPEUTICS, INC., a Delaware corporation ("
OREXIGEN "), and CYPRESS BIOSCIENCE, INC., a Delaware
corporation (" CYPRESS ").
WHEREAS, OREXIGEN has certain
intellectual property rights relating to technology which enhances
human weight loss; and
WHEREAS, CYPRESS desires to
acquire certain rights to such OREXIGEN technology to reduce weight
gain associated with the use of certain therapeutics; and
NOW THEREFORE, in consideration of
the premises and the mutual covenants contained herein, the parties
hereto agree as follows:
ARTICLE 1 – DEFINITIONS
For the purposes of this
AGREEMENT, and solely for that purpose, the terms and phrases set
forth below and elsewhere in this AGREEMENT in capital letters
shall be defined as follows:
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1.01
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" AFFILIATE " means any corporation or
non-corporate entity which controls, is controlled by or is under
the common control with a party hereto. A corporation or a
non-corporate entity, as applicable, shall be regarded as in
control of another corporation if it owns or directly or indirectly
controls at least fifty percent (50%) of the voting stock of the
other corporation, or in the absence of ownership of at least fifty
percent (50%) of the voting stock of a corporation, or in the case
of a non corporate entity, if it possesses directly or indirectly,
the power to direct or cause the direction of the management and
policies of such corporation or non-corporate entity, as
applicable.
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1.02
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" AGENT " means any employee, consultant,
agent or individual or entity that has either assigned or licensed
INTELLECTUAL PROPERTY to a party hereto.
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1.03
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" ARBITRATION ISSUES " shall have the
meaning given in Section 20.04(a).
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1.04
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" ARBITRATION PANEL " shall have the
meaning given in Section 20.03.
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1.05
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" CLAIMANT " shall have the meaning given
in Section 20.04(a).
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1.06
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" CLAIMANT’S PROPOSAL " shall have
the meaning given in Section 20.04(b) .
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1.07
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" CLAIMS " shall have the meaning given in
Section 14.01 .
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1.08
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" CLINICAL STRATEGY ASSISTANCE " shall
have the meaning given in Section 4.03 .
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1.09
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" COLLABORATION CYPRESS INTELLECTUAL
PROPERTY " means all INTELLECTUAL PROPERTY during the term of
this AGREEMENT:
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(a)
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conceived solely by one or more AGENTS of CYPRESS
in the course of work performed pursuant to this AGREEMENT;
and/or
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(b)
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that is an IMPROVEMENT to any PRE-COLLABORATION
CYPRESS INTELLECTUAL PROPERTY or COLLABORATION CYPRESS INTELLECTUAL
PROPERTY:
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(i)
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conceived solely by AGENTS of OREXIGEN in the
course of the COLLABORATIVE WORK; or
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(ii)
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conceived jointly by one or more AGENTS of
CYPRESS and one or more AGENTS of OREXIGEN in the course of the
COLLABORATIVE WORK.
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1.10
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" COLLABORATION INTELLECTUAL PROPERTY "
means the COLLABORATION CYPRESS INTELLECTUAL PROPERTY",
COLLABORATION JOINT INTELLECTUAL PROPERTY and/or COLLABORATION
OREXIGEN INTELLECTUAL PROPERTY.
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1.11
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" COLLABORATION JOINT INTELLECTUAL
PROPERTY " means all INTELLECTUAL PROPERTY conceived jointly by
one or more AGENTS of CYPRESS and one or more AGENTS of OREXIGEN in
the course of the COLLABORATIVE WORK, but excluding any such
INTELLECTUAL PROPERTY which is an IMPROVEMENT to any
PRE-COLLABORATION CYPRESS INTELLECTUAL PROPERTY or COLLABORATION
CYPRESS INTELLECTUAL PROPERTY or to any PRE-COLLABORATION OREXIGEN
INTELLECTUAL PROPERTY or COLLABORATION OREXIGEN INTELLECTUAL
PROPERTY.
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1.12
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" COLLABORATION OREXIGEN INTELLECTUAL
PROPERTY " means all INTELLECTUAL PROPERTY conceived during the
term of this AGREEMENT:
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(a)
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solely by one or more AGENTS of OREXIGEN in the
course of work performed pursuant to this AGREEMENT;
and/or
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(b)
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that is an IMPROVEMENT to any PRE-COLLABORATION
OREXIGEN INTELLECTUAL PROPERTY or COLLABORATION OREXIGEN
INTELLECTUAL PROPERTY:
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(i)
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conceived solely by AGENTS of CYPRESS in the
course of the COLLABORATIVE WORK; or
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(ii)
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conceived jointly by one or more AGENTS of
CYPRESS and one or more AGENTS of OREXIGEN in the course of the
COLLABORATIVE WORK.
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1.13
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" COLLABORATIVE WORK " shall have the
meaning given in Section 4.01 .
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1.14
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" COLLABORATIVE WORK PLAN " shall have the
meaning given in Section 4.01 .
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1.15
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" CYPRESS INDEMNITEES " shall have the
meaning given in Section 14.02 .
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1.16
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" CYPRESS MATERIALS " means any
proprietary materials provided by CYPRESS to OREXIGEN as part of
the COLLABORATIVE WORK.
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1.17
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" DISPUTE " shall have the meaning given
in Section 20.02 .
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1.18
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" DUKE AGREEMENT " means that certain
License Agreement dated March 31, 2004, by and between Duke
University and OREXIGEN, as amended by Amendment No. 1
thereto, dated as of even date herewith.
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1.19
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" DUKE PATENT RIGHTS " means the patents
and patent applications listed on APPENDIX A, together with all
divisions, continuations, continuations-in-part (but only to the
extent that the subject matter of each such continuation-in-part
application is described in and enabled by the disclosure of such
patent applications listed on APPENDIX A), re-examinations,
reissues, substitutions, or extensions thereof and patents issuing
therefrom in the United States and non-U.S. jurisdictions, which
are licensed to OREXIGEN under the DUKE AGREEMENT.
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1.20
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" DUKE SUBLICENSE " means the sublicense
under the DUKE AGREEMENT to practice under the DUKE PATENT RIGHTS,
which is included in the LICENSE.
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1.21
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" ELAN PARTIES " shall have the meaning
given in Section 14.02.
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1.22
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" FIELD " means all human
indications.
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1.23
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" FINAL DECISION " shall have the meaning
given in Section 20.04(c).
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1.24
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" IMPROVEMENT " means any invention that
is an improvement to, or modification, of an existing invention
claimed in any patent application or patent within the INTELLECTUAL
PROPERTY of a party.
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1.25
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" INTELLECTUAL PROPERTY " means all
intellectual property rights worldwide arising under statutory or
common law, and whether or not perfected, including, without
limitation, all (A) patents and patent applications now
existing or hereafter filed, issued or acquired, together with all
divisions, continuations, continuations-in-part (but only to the
extent that the subject matter of each such
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continuation-in-part application is described in
and enabled by the disclosure of any such patent application),
re-examinations, reissues, substitutions, or extensions thereof and
patents issuing therefrom in the United States and non-U.S.
jurisdictions; (B) rights associated with works of authorship
including copyrights, copyright applications and copyright
registrations; and (C) rights relating to the protection of
trade secrets, know-how and CONFIDENTIAL INFORMATION.
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1.26
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" LICENSE " means the exclusive, worldwide
license rights granted pursuant to Section 2.01, including,
but not limited to, the DUKE SUBLICENSE .
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1.27
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" LICENSED PROCESS " means any process
which is covered in whole or in part by a VALID CLAIM contained in
the OREXIGEN PATENT RIGHTS and is used, performed or practiced with
respect to any LICENSED PRODUCT.
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1.28
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" LICENSED PRODUCT " means any product or
part thereof containing mirtazapine or setiptiline in any form,
(including, without limitation, any and all enantiomers, analogs,
derivatives and salts thereof) used in combination with one or more
active ingredients, which:
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(a)
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is covered in whole or in part by any VALID CLAIM
contained in the OREXIGEN PATENT RIGHTS in the country in which any
such product or part thereof is made, used or sold;
and/or
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(b)
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is manufactured by using a process or is employed
to practice a process which is covered in whole or in part by a
VALID CLAIM contained in the OREXIGEN PATENT RIGHTS in the country
in which any LICENSED PROCESS is used or in which such product or
part thereof is used or sold; and/or
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(c)
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in its intended use, practices, incorporates, or
otherwise utilizes, in whole, or in part, a VALID CLAIM contained
in the OREXIGEN PATENT RIGHTS in the country in which any such
product or part thereof is made, used, or sold.
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"LICENSED PRODUCTS" shall also mean, unless the
context otherwise clearly requires, the following terms,
collectively: LICENSED PRODUCTS, LICENSED PROCESSES, and LICENSED
SERVICES, and a LICENSED PROCESS and LICENSED SERVICE shall be
included within such term notwithstanding such process or service
is not literally a physical "product".
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1.29
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" LICENSED SERVICE " means any service
provided by CYPRESS (and/or SUBLICENSEES, as the case may be) to a
THIRD PARTY which utilizes LICENSED PRODUCTS and/or LICENSED
PROCESSES.
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1.30
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" NET SALES " means:
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(a)
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in the case of LICENSED PRODUCTS, CYPRESS’s
(and/or those of SUBLICENSEES, as the case may be) revenues
received from sale and/or lease of the subject LICENSED PRODUCTS;
and
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(b)
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in the case of LICENSED PROCESSES,
CYPRESS’s (and/or those of SUBLICENSEES, as the case may be)
revenues received from sale and/or lease of the subject LICENSED
PROCESSES; and
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(c)
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in the case of LICENSED SERVICES, revenue
received by CYPRESS (and/or SUBLICENSEES, as the case may be) for
provision of the subject LICENSED SERVICE to a THIRD
PARTY
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and each of (a), (b) and (c), above shall be
less the sum of the following:
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(w)
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discounts allowed in amounts customary in the
trade;
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(x)
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sales, tariff duties and/or use taxes directly
imposed and with reference to particular sales;
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(y)
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outbound transportation prepaid or allowed;
and
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(z)
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amounts allowed or credited on
returns.
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No deductions to NET SALES shall be made for
commissions paid to individuals whether they are associated with
independent sales agencies or regularly employed by CYPRESS (and/or
SUBLICENSEES, as the case may be) and on its payroll, or for cost
of collections. LICENSED PRODUCTS shall be considered "sold" when
the consideration for provision thereof is received by CYPRESS
(and/or SUBLICENSEES, as the case may be). LICENSED PRODUCTS and
LICENSED SERVICES used by CYPRESS (and/or SUBLICENSEES, as the case
may be) for clinical field trials, provided as free-of-charge
samples for distribution to customers or end users, or for
CYPRESS’s own internal non-commercial research (and/or
SUBLICENSEES, as the case may be) shall not be included in NET
SALES.
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Except as provided below, if a LICENSED PRODUCT
is sold in combination with another active component or components
not otherwise claimed in the OREXIGEN PATENT RIGHTS and CYPRESS
does not pay a royalty for such component that will result in a
reduced RUNNING ROYALTY pursuant to Section 3.01(b) ,
then the NET SALES, for purposes of determining royalties on the
combination, will be calculated by multiplying the NET SALES of the
combination by the fraction A/(A+B), where A is the invoice price
of the LICENSED PRODUCT, LICENSED PROCESS or LICENSED SERVICE if
sold separately and B is the total invoice price of any other
active component or components in the combination if sold
separately. If the LICENSED PRODUCT, LICENSED PROCESS or LICENSED
SERVICE and the other active component
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or components in the combination are not sold
separately, the NET SALES, for purposes of determining royalties on
the combination, will be calculated by multiplying the NET SALES of
the combination by the fraction determined by mutual agreement of
the parties, that reflects the relative contribution in value that
the LICENSED PRODUCT contained in the combination makes to the
total value of such combination to the end user.
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1.31
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" NOTICE OF ARBITRATION " shall have the
meaning given in Section 20.04(a) .
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1.32
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" OPTION EXERCISE DEADLINE " means the
[***] of the EFFECTIVE DATE, which may be extended as provided in
Section 4.02 .
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1.33
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" OPTION TERM " means the period
commencing with the EFFECTIVE DATE and expiring on the OPTION
EXERCISE DEADLINE. The OPTION TERM may be extended for not more
than [***]([***]) days as provided in Section 4.02
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1.34
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" OREXIGEN INTELLECTUAL PROPERTY RIGHTS "
means any and all OREXIGEN PATENT RIGHTS, PRE-COLLABORATION
OREXIGEN INTELLECTUAL PROPERTY, COLLABORATION OREXIGEN INTELLECTUAL
PROPERTY, and OREXIGEN rights in or to COLLABORATION JOINT
INTELLECTUAL PROPERTY.
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1.35
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" OREXIGEN MATERIALS " means any
proprietary materials provided by OREXIGEN to CYPRESS.
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1.36
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" OREXIGEN PATENT RIGHTS "
means:
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(a)
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the DUKE PATENT RIGHTS; and
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(b)
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any and all patents, patent applications and
rights to file any patent applications with respect to any
COLLABORATION OREXIGEN INTELLECTUAL PROPERTY, together with all
divisions, continuations, continuations-in-part (but only to the
extent that the subject matter of each such continuation-in-part
application is described in and enabled by the disclosure of any
such patent applications), re-examinations, reissues,
substitutions, or extensions thereof and patents issuing from any
such patent applications in the United States and non-U.S.
jurisdictions; and or
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(c)
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OREXIGEN rights in or to all patents, patent
applications and rights to file any patent applications with
respect to any COLLABORATION JOINT INTELLECTUAL PROPERTY, together
with all divisions, continuations, continuations-in-part (but only
to the extent that the subject matter of each such
continuation-in-part application is described in and enabled by the
disclosure of any such patent applications), re-examinations,
reissues, substitutions, or extensions thereof and patents issuing
from any such patent applications in the United States and non-U.S.
jurisdictions.
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***
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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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1.37
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" PAYMENT TRANSFER FEES " shall have the
meaning given in Section 3.05 .
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1.38
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" PRE-CLINICAL STUDIES " shall have the
meaning given in Section 4.02 .
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1.39
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" PRE-COLLABORATION CYPRESS INTELLECTUAL
PROPERTY " means all INTELLECTUAL PROPERTY owned by, either
partially or wholly, or licensed to, or otherwise controlled by,
CYPRESS, as of the EFFECTIVE DATE.
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1.40
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" PRE-COLLABORATION INTELLECTUAL PROPERTY
" means the PRE-COLLABORATION CYPRESS INTELLECTUAL PROPERTY and/or
PRE-COLLABORATION OREXIGEN INTELLECTUAL PROPERTY.
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1.41
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" PRE-COLLABORATION OREXIGEN INTELLECTUAL
PROPERTY " means all OREXIGEN PATENT RIGHTS as of the EFFECTIVE
DATE and all other INTELLECTUAL PROPERTY owned by, either partially
or wholly, or licensed to, or otherwise controlled by, OREXIGEN as
of the EFFECTIVE DATE necessary to practice the OREXIGEN PATENT
RIGHTS and all INTELLECTUAL PROPERTY, excluding those defined in
subsection 1.25(A) of this AGREEMENT, owned by, either partially or
wholly, or licensed to, or otherwise controlled by, OREXIGEN as of
the EFFECTIVE DATE useful to practice the OREXIGEN PATENT
RIGHTS.
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1.42
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" RESPONDENT " shall have the meaning
given in Section 20.04(a) .
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1.43
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" RESPONDENT’S PROPOSAL " shall have
the meaning given in Section 20.04(b) .
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1.44
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" REPONSE " shall have the meaning given
in Section 20.04(a) .
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1.45
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" RUNNING ROYALTY " shall have the meaning
given in Section 3.01(b) .
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1.46
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" SUBLICENSE " and " SUBLICENSE
AGREEMENT " means any relationship/agreement in which a THIRD
PARTY gains any rights, temporary or otherwise, to any of the
rights granted by OREXIGEN to CYPRESS under this AGREEMENT
(including, but not limited to, CYPRESS AFFILIATES, assignee(s),
licensee(s), sublicensee(s), marketing partner(s) and the like,
hereinafter, such THIRD PARTIES referred as "SUBLICENSEES"),
including, but not limited to those granted via options, rights of
first refusal, material transfer agreements, sublicenses (implied
or expressed), and the like, but excluding any THIRD PARTY that
purchases LICENSED PRODUCTS as the end user thereof.
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1.47
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" TERRITORY " means the world.
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1.48
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" THIRD PARTY " means any individual or
other entity other than OREXIGEN and/or CYPRESS.
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1.49
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" VALID CLAIM " means (i) an issued
and unexpired claim within the OREXIGEN PATENT RIGHTS that has not
been permanently revoked or held
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invalid or unenforceable by a decision of a court
or other governmental agency of competent jurisdiction and that has
not been dedicated to the public or admitted to be invalid or
unenforceable through reissue, disclaimer or otherwise, or
(ii) a claim of a pending patent application within the
OREXIGEN PATENT RIGHTS that was filed in good faith, has not been
pending for more than [***]([***]) years, and which has not been
abandoned or finally disallowed without the possibility of appeal
or refiling of such application contained in the OREXIGEN PATENT
RIGHTS in the country in which any such product or part thereof is
made, used or sold.
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1.50
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Where appropriate, words denoting a singular
number only shall include the plural and vice versa.
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1.51
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Certain other defined terms shall have the
meanings given them elsewhere in this AGREEMENT.
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ARTICLE 2 –
OPTION/LICENSE/SUBLICENSES
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2.01
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LICENSE . OREXIGEN hereby grants to
CYPRESS and CYPRESS hereby accepts from OREXIGEN, subject to the
terms, conditions and restrictions of this AGREEMENT, the
exclusive, worldwide right and sublicenseable license (or, in the
case of the DUKE PATENT RIGHTS, sublicense) under the OREXIGEN
INTELLECTUAL PROPERTY RIGHTS, until the end of the term for which
the OREXIGEN PATENT RIGHTS are granted, unless this AGREEMENT shall
be sooner terminated according to the terms hereinafter provided
to:
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(a)
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develop, make, have made, import, use, lease,
offer for sale, sell, and distribute LICENSED PRODUCTS;
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(b)
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develop, make, have made, import, use, lease,
offer for sale, sell, and distribute LICENSED PROCESSES;
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(c)
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develop, make, have made, perform, provide,
import, use, lease, offer for sale, sell, and distribute LICENSED
SERVICES; and/or
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(d)
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practice and use the OREXIGEN INTELLECTUAL
PROPERTY RIGHTS, other than OREXIGEN PATENT RIGHTS, and to use the
OREXIGEN MATERIALS, insofar as such practice and use is required to
carry out the activities under subsections (a)-(c)
above.
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2.02
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LICENSE RESTRICTIONS .
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(a)
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The LICENSE shall be limited to the FIELD and the
TERRITORY.
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(b)
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CYPRESS agrees not to develop, market or sell,
directly or indirectly, a LICENSED PRODUCT under the OREXIGEN
INTELLECTUAL PROPERTY RIGHTS that is a combination of
[***].
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***
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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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(c)
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CYPRESS agrees not to develop, market or sell,
directly or indirectly, a LICENSED PRODUCT under the OREXIGEN
INTELLECTUAL PROPERTY RIGHTS for an indication for weight loss
and/or the treatment of obesity but CYPRESS may develop a LICENSED
PRODUCT under the OREXIGEN INTELLECTUAL PROPERTY RIGHTS for an
indication for which the label discusses the prevention of weight
gain associated with mirtazapine or setiptiline.
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2.03
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OPTION/EFFECTIVENESS OF LICENSE . The
LICENSE granted by OREXIGEN to CYPRESS under Section 2.01
shall not become effective unless and until CYPRESS exercises its
option (the " OPTION "), in accordance with the terms and
conditions of this Section 2.03 , that the LICENSE
shall become effective. The OPTION shall be exercisable only during
the OPTION TERM. Exercise of the OPTION must be in writing and
clearly establish the unconditional intention of CYPRESS to make
the LICENSE effective. If CYPRESS has not exercised the OPTION and
timely delivered the payments required by
Section 3.01(b) during the OPTION TERM, then the OPTION
shall expire and irrevocably terminate.
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2.04
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SUBLICENSES . CYPRESS shall have the
right to grant SUBLICENSES. All SUBLICENSES shall be subject to the
terms and conditions of this AGREEMENT, shall be no less favorable
to or protective of OREXIGEN than this AGREEMENT except as
expressly stated in this AGREEMENT and CYPRESS shall remain
responsible for the performance of its THIRD PARTY sublicensees.
All SUBLICENSES will be assigned to OREXIGEN in the event the
AGREEMENT is terminated by OREXIGEN pursuant to
Sections 10.04 , 10.05 , or 10.06 , subject to
OREXIGEN’s approval, such approval not to be unreasonable
withheld or delayed. CYPRESS shall use commercially reasonable
efforts to enforce the terms of the SUBLICENSE agreements. CYPRESS
further agrees to provide OREXIGEN with a copy of all SUBLICENSES
within thirty (30) days of execution of each subject
SUBLICENSE. No SUBLICENSES (whether or not conditional or subject
to effectiveness of the LICENSE) may be granted by CYPRESS,
however, prior to exercise of the OPTION by CYPRESS.
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2.05
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NO OTHER RIGHTS GRANTED . The LICENSE
granted under this AGREEMENT will not be construed to confer any
rights upon CYPRESS by implication, estoppel or otherwise as to any
intellectual property data, technology or other property rights
held by OREXIGEN (solely or jointly) not specifically set forth
herein, regardless of whether such property rights are dominant or
subordinate to any of the OREXIGEN PATENT RIGHTS.
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2.06
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DUKE AGREEMENT . OREXIGEN agrees that
it will not enter into any amendment of the DUKE AGREEMENT which
diminishes the rights and/or interests of CYPRESS under this
AGREEMENT, without the prior written consent of CYPRESS, which
shall not be unreasonably withheld.
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ARTICLE 3 – LICENSE FEE, ROYALTIES AND
OTHER FEES
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3.01
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COMPENSATION TO OREXIGEN . In
consideration of the right granted to CYPRESS pursuant to this
AGREEMENT by OREXIGEN, and the performance of the services by
OREXIGEN as specified in Section 4.02 , and further
subject to the terms and conditions of this AGREEMENT, CYPRESS
agrees to pay OREXIGEN as follows:
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(a)
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Upfront Payments . CYPRESS shall make
payments to OREXIGEN as follows:
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(i)
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the sum of One Million Dollars ($1,000,000) at
the time of execution of this AGREEMENT, which shall include
support for activities of OREXIGEN under the COLLABORATIVE WORK
PLAN; and
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(ii)
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the sum of Five Hundred Thousand Dollars
($500,000) on the earlier of February 1, 2005 or the OPTION
EXERCISE DATE.
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(b)
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Royalty on NET SALES of LICENSED
PRODUCTS . At the times and in the manner set forth
hereinafter, CYPRESS shall pay to OREXIGEN a non-refundable running
royalty on NET SALES of LICENSED PRODUCTS (hereinafter such running
royalty referred to as the " RUNNING ROYALTY "), based on the
level of NET SALES during any calendar year, as follows:
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Royalty
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Rate
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Annual NET SALES
Levels
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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[***]
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The applicable RUNNING ROYALTY rate for a
particular NET SALES level shall apply only to such NET SALES
level. Therefore, as an example, if NET SALES for a particular
calendar year were $400 million, [***].
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***
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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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Notwithstanding the foregoing, if
(a) CYPRESS (and/or appertaining SUBLICENSEES, as the case may
be) obtains from any THIRD PARTY any licenses and/or sublicenses
for patent rights in order to practice OREXIGEN PATENT RIGHTS in
the FIELD or in order to develop, make, have made, use, import,
offer for sale, sell, import, export or provide LICENSED PRODUCTS
(including, without limitation, as a result of any claim referred
to in subsection (b)), or (b) any claim is made against
CYPRESS (and/or appertaining SUBLICENSEES, as the case may be)
alleging that the practice of the OREXIGEN PATENT RIGHTS in the
FIELD infringes any THIRD PARTY patent, then CYPRESS (and/or
appertaining SUBLICENSEES, as the case may be) shall be entitled to
credit, in the case of subsection (a), any payment by CYPRESS
(and/or appertaining SUBLICENSEES, as the case may be) of
additional running royalties to such THIRD PARTY(ies), if any, on
LICENSED PRODUCTS, and, in the case of subsection (b), fifty
percent (50%) of any reasonable costs and expenses (including,
without limitation, attorneys’ fees, but excluding any
judgments or any settlements in connection with such claims)
incurred by CYPRESS (and/or appertaining SUBLICENSEES, as the case
may be) in connection with any such infringement claim against the
RUNNING ROYALTY for the subject LICENSED PRODUCTS, in the
appertaining country(ies) during the appertaining time period,
provided that in no event shall the amount otherwise payable to
OREXIGEN as RUNNING ROYALTY be reduced to less than [***] percent
([***]%) of NET SALES for the subject LICENSED PRODUCTS in the
appertaining country(ies) during the appertaining time period;
provided further that, in the case of subsection (b), any amounts
that would have been credited in any period, but are not credited
due to the [***] percent ([***]%) limitation, shall be carried
forward to the following periods until all such amounts have been
credited against the RUNNING ROYALTY for the subject LICENSED
PRODUCTS.
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Without limiting the credit available above, in
the case of RUNNING ROYALTIES payable by CYPRESS for NET SALES by
any SUBLICENSEE, the RUNNING ROYALTY payable by CYPRESS shall not
exceed [***] percent ([***]%) of royalties received by CYPRESS from
such SUBLICENSEE (net of any payment on such royalties that CYPRESS
is obligated to pay to THIRD PARTIES with respect to LICENSED
PRODUCTS) but in no event will be lower than [***] percent ([***]%)
of such NET SALES by such SUBLICENSEE.
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The RUNNING ROYALTIES shall be payable on a
LICENSED PRODUCT by LICENSED PRODUCT and country by country basis
from the date of first commercial sale of a given, LICENSED PRODUCT
in a given country until, the expiration of the last to expire of
the OREXIGEN PATENT RIGHTS containing a VALID CLAIM that, absent
assignment or license, would be infringed by the manufacture, use
or sale of such LICENSED PRODUCT in such country.
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(c)
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Milestone Payments . CYPRESS (and/or
appertaining SUBLICENSEES, as the case may be) shall pay OREXIGEN
the following one-time, noncreditable, non-refundable payments
within [***]([***]) days of the first
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***
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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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occurrence of each of the following milestones
achieved by CYPRESS (and/or any SUBLICENSEES, as the case may be)
as relates to a LICENSED PRODUCT:
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[***]
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3.02
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TAXES . OREXIGEN shall pay any and all
taxes levied on account of any payments made to it under this
AGREEMENT. If any such taxes are required to be withheld by CYPRESS
(and/or appertaining SUBLICENSEES, as the case may be), CYPRESS
(and/or appertaining SUBLICENSEES, as the case may be) will
(a) deduct such taxes from the payment made to OREXIGEN,
(b) timely pay the taxes to the proper taxing authority, and
(c) send proof of payment to OREXIGEN and certify its receipt
by the taxing authority within forty-five (45) calendar days
following such payment.
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3.03
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LATE PAYMENTS . All payments due from
CYPRESS (and/or appertaining SUBLICENSEES, as the case may be)
pursuant to this AGREEMENT shall be due and payable in accordance
with the terms and conditions of this AGREEMENT, and if a payment
due pursuant to this AGREEMENT is not paid within [***] ([***])
days of the payment due date, then a late payment fee equal to
[***] percent ([***]%) of such payment shall, be added to the
payment due; provided, however, in addition to the late fee
described above, all past due payments shall bear interest at the
[***]
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***
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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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[***] from the due date of such payment until paid. The payment
of such interest and late fees shall not foreclose OREXIGEN from
exercising any other rights it may have as a consequence of the
lateness of any payment.
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3.04
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NO MULTIPLE ROYALTIES . No multiple
royalties on NET SALES shall be payable to OREXIGEN on a single
LICENSED PRODUCT because its manufacture; use, lease, sale or
practice are or shall be covered by more than one of the OREXIGEN
PATENT RIGHTS. In addition, no royalty on NET SALES shall be
payable to OREXIGEN with respect to any LICENSED PROCESS or
LICENSED SERVICE to the extent a royalty on NET SALES is paid to
OREXIGEN with respect to a LICENSED PRODUCT used in or resulting
from such LICENSED PRODESS or LICENSED SERVICE.
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3.05
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METHOD OF PAYMENT . All payments due to
OREXIGEN under this AGREEMENT shall be paid in United States
Dollars in Princeton, New Jersey, or at such place as OREXIGEN may
reasonably designate consistent with the laws and regulations
controlling in any foreign country. If any currency conversion
shall be required in connection with such payments due hereunder,
such conversion shall be made by using the exchange rate prevailing
at Bank of America (N.A.) (or its successor, as the case may be) on
the last business day of the reporting period to which such
payments relate. If payments are made by wire, electronic or other
transfer form for which a fee is charged (" PAYMENT TRANSFER
FEES "), CYPRESS (and/or appertaining SUBLICENSEES, as the case may
be) shall be responsible for the full amount of such fees and shall
promptly reimburse OREXIGEN for OREXIGEN’s payment of such
reasonable PAYMENT TRANSFER FEES within thirty (30) days of
invoice of the same from OREXIGEN. OREXIGEN shall be responsible
for making all payments required of OREXIGEN under the DUKE
AGREEMENT.
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ARTICLE 4 – COLLABORATIVE WORK/DUE
DILIGENCE REQUIREMENTS
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4.01
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COLLABORATIVE WORK . CYPRESS and
OREXIGEN shall collaborate in the development of LICENSED PRODUCTS
through assistance to be provided by OREXIGEN as outlined on
APPENDIX B and referred to herein as the " COLLABORATIVE WORK
PLAN ", which shall include the PRE-CLINICAL STUDIES and CLINICAL
STRATEGY ASSISTANCE (the " COLLABORATIVE WORK "). The
COLLABORATIVE WORK PLAN shall be updated by mutual agreement of
OREXIGEN and CYPRESS within thirty (30) days of the date of
this AGREEMENT. CYPRESS shall have final decision-making authority
with regard to development and commercialization of LICENSED
PRODUCTS, including, without limitation, whether to develop any
LICENSED PRODUCTS for depression. OREXIGEN shall make all
PRE-COLLABORATION OREXIGEN INTELLECTUAL PROPERTY and COLLABORATION
OREXIGEN INTELLECTUAL PROPERTY available for review by CYPRESS.
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***
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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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4.02
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PRE-CLINICAL STUDIES . Under the
COLLABORATIVE WORK PLAN, OREXIGEN, through [***] (a consultant of
OREXIGEN), shall conduct pre-clinical studies (the "
PRE-CLINICAL STUDIES ") at [***]. The PRE-CLINICAL STUDIES shall
include:
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(a)
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[***] ; and
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(b)
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[***] .
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The parties recognize that, taking into account
the uncertainties of drug development, it may be necessary, from
time to time, to amend the objectives of the COLLABORATIVE WORK
PLAN and/or extend the delivery date of the data from PRE-CLINICAL
STUDIES. CYPRESS hereby agrees to accept any reasonable proposals
to amend the scope of the COLLABORATIVE WORK PLAN in light of
OREXIGEN’S experience in conducting the PRE-CLINICAL STUDIES,
provided that such amendments, in the aggregate, shall not result
in an extension of completion of the PRE-CLINICAL STUDIES by more
than [***]([***]) days. The PRE-CLINICAL STUDIES shall be deemed
completed when OREXIGEN delivers to CYPRESS data which satisfies
all requirements and objectives established in the COLLABORATIVE
WORK PLAN. Any extension of the completion of the PRE-CLINICAL
STUDIES beyond [***]([***]) days shall extend the OPTION EXERCISE
DEADLINE by the extent to which such extension exceeds
[***]([***])[***].
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4.03
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CLINICAL STRATEGY ASSISTANCE . OREXIGEN
shall assist CYPRESS in its strategy with, respect to the planned
proof of concept trials (the " CLINICAL STRATEGY ASSISTANCE "),
as described in the COLLABORATIVE WORK PLAN. CYPRESS will have
responsibility and sole decision making authority with respect to
all clinical trials for LICENSED PRODUCTS, including, without
limitation, the planned proof of concept trials, and all regulatory
and other matters relating to the LICENSED PRODUCTS.
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4.04
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OWNERSHIP OF INTELLECTUAL PROPERTY
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(a)
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PRE-COLLABORATION CYPRESS INTELLECTUAL
PROPERTY and COLLABORATION CYPRESS INTELLECTUAL PROPERTY .
All rights and title to PRE-COLLABORATION CYPRESS INTELLECTUAL
PROPERTY will belong to CYPRESS, and all rights and title to
COLLABORATION CYPRESS INTELLECTUAL PROPERTY, whether patentable or
copyrightable or not, will belong to CYPRESS.
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(b)
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PRE-COLLABORATION OREXIGEN INTELLECTUAL
PROPERTY and COLLABORATION OREXIGEN INTELLECTUAL PROPERTY
.
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***
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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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All rights and title to PRE-COLLABORATION
OREXIGEN INTELLECTUAL PROPERTY will belong to OREXIGEN and all
rights and title to COLLABORATION OREXIGEN INTELLECTUAL PROPERTY,
whether patentable or copyrightable or not, will belong to
OREXIGEN, subject to the LICENSE to be granted
hereunder.
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(c)
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COLLABORATION JOINT INTELLECTUAL
PROPERTY . All rights and title to COLLABORATION JOINT
INTELLECTUAL PROPERTY, whether patentable or copyrightable or not,
will belong jointly to CYPRESS and OREXIGEN and will be subject to
the terms and conditions of this AGREEMENT. Each party will have
the right to independently practice and to license such
COLLABORATION JOINT INTELLECTUAL PROPERTY, without accounting to
the other party, subject to the LICENSE during the term of this
AGREEMENT, and only to the extent that the practice of such
COLLABORATION JOINT INTELLECTUAL PROPERTY by CYPRESS or any
sublicensee does not require rights under PRE-COLLABORATION
OREXIGEN INTELLECTUAL PROPERTY, COLLABORATION OREXIGEN INTELLECTUAL
PROPERTY, or any other INTELLECTUAL PROPERTY owned by, either
partially or wholly, or licensed to OREXIGEN, and that the practice
of such COLLABORATION JOINT INTELLECTUAL PROPERTY by OREXIGEN or
any sublicensee does not require rights under PRE-COLLABORATION
CYPRESS INTELLECTUAL PROPERTY, COLLABORATION CYPRESS INTELLECTUAL
PROPERTY, or any other INTELLECTUAL PROPERTY owned by, either
partially or wholly, or licensed to CYPRESS. If such COLLABORATION
JOINT INTELLECTUAL PROPERTY contains any PRE-COLLABORATION
INTELLECTUAL PROPERTY, COLLABORATION INTELLECTUAL PROPERTY or other
INTELLECTUAL PROPERTY owned by, either partially or wholly, or
licensed to, the other party, the inventing party will only have
the rights to practice and license the COLLABORATION JOINT
INTELLECTUAL PROPERTY as negotiated with such other party pursuant
to a license agreement or other agreed-upon arrangement.
Notwithstanding the foregoing, OREXIGEN shall not have the right to
practice or to license (other than to CYPRESS) any COLLABORATION
JOINT INTELLECTUAL PROPERTY, to the extent of the LICENSE granted
to CYPRESS, so long as the LICENSE is in effect. Additionally,
subject to the provisions of Section 8.02 , so long as the
LICENSE is in effect, each party will have the right but not the
obligation to bring, at its own expense, an infringement action
against any third party under its interest in COLLABORATION JOINT
INTELLECTUAL PROPERTY, subject to the same limitations as set forth
above with respect to the practice of such COLLABORATION JOINT
INTELLECTUAL PROPERTY by CYPRESS or OREXIGEN. The parties will
assist one another and cooperate in any such litigation, at the
other’s reasonable request, and, if a party is necessary in
order to institute and maintain an infringement suite
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by the other party as defined by law, that party
agrees to be joined in such suit.
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(d)
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Reporting Inventions . The parties
agree to use reasonable efforts to report inventions conceived
and/or reduced to prac
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