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.
THIS AGREEMENT
made and entered into this 1st day of June, 2004 (“EFFECTIVE
DATE”), by and between LEE G. DANTE, an individual having his
principal office at [***] (“DANTE”), and OREXIGEN
THERAPEUTICS, INC., a corporation organized under the laws of
Delaware (“OREXIGEN”), with its corporate headquarters
and principal office at One Palmer Square, Suite 515,
Princeton, NJ 08540.
WHEREAS, DANTE
owns certain PATENT RIGHTS (as hereinafter defined);
WHEREAS, DANTE has
the right to grant licenses under said PATENT RIGHTS;
and
WHEREAS, DANTE
desires to have the PATENT RIGHTS developed and commercialized to
benefit the public and is willing to grant licenses to each
hereunder; and
WHEREAS, OREXIGEN
desires to obtain licenses under PATENT RIGHTS and upon the terms
and conditions hereinafter set forth; and
NOW THEREFORE, in
consideration of the premises and the mutual covenants contained
herein, the parties hereto agree as follows:
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” shall mean
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-cooperate entity, as applicable.
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1.02
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“CONSULTING AGREEMENT”
shall have the meaning given in Section 3.01(f).
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1.03
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“FIELD OF USE” shall
mean any and all uses.
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1.04
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“FULLY DILUTED BASIS”
means the total number of issued and outstanding shares of the
OREXIGEN’s common stock, $.001 par value (“OREXIGEN
COMMON STOCK”), calculated to include (i) conversion of
all issued and
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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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outstanding securities then
convertible into OREXIGEN COMMON STOCK, (ii) the exercise of
all then outstanding options and warrants to purchase shares of
OREXIGEN COMMON STOCK, whether or not then exercisable (other than
options covered under the following clause (iii)), and
(iii) the issuance or grant of all securities reserved for
issuance pursuant to any stock or stock option plan of OREXIGEN in
effect on the date of the calculation.
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1.05
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“LICENSED PROCESS” shall
mean any process which is covered in whole or in part by a VALID
CLAIM contained in the PATENT RIGHTS.
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1.06
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“LICENSED PRODUCT” shall
mean any product or part thereof which:
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(a)
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is
covered in whole or in part by any VALID CLAIM contained in the
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 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 PATENT RIGHTS
in the country in which any such product or part thereof is made,
used, or sold.
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1.07
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“LICENSED SERVICE” shall
mean any service provided by OREXIGEN (and/or SUBLICENSEES, as the
case may be) to a THIRD PARTY which utilizes LICENSED PRODUCTS
and/or LICENSED PROCESSES.
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1.08
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“NET SALES” shall
mean:
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(a)
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in
the case of LICENSED PRODUCTS, OREXIGEN’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, OREXIGEN’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 OREXIGEN (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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- 2 -
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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 OREXIGEN (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 OREXIGEN (and/or
SUBLICENSEES, as the case may be). LICENSED PRODUCTS, LICENSED
SERVICES, and LICENSED SERVICES used by OREXIGEN (and/or
SUBLICENSEES, as the case may be) for its own use in the FIELD (and
not in connection with the sale to THIRD PARTIES) shall be
considered to be “NET SALES” for purposes of computing
royalty obligations, except to the extent that such LICENSED
PRODUCTS and/or LICENSED SERVICES are used for clinical field
trials or for OREXIGEN’s own internal non-commercial research
(and/or SUBLICENSEES, as the case may be).
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Except as provided below, if a
LICENSED PRODUCT, LICENSED PROCESS or LICENSED SERVICE is sold in
combination with another active component or components, the NET
SALES PRICE, for purposes of determining royalties on the
combination, will be calculated by multiplying the NET SALES PRICE
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 or components in the
combination are not sold separately, the NET SALES PRICE, for
purposes of determining royalties on the combination, will be
calculated by multiplying the NET SALES PRICE of the combination by
the fraction C/(C+D), where C is the actual manufacturing cost of
the LICENSED PRODUCT, LICENSED PROCESS or LICENSED SERVICE and D is
the total actual manufacturing cost any other active component(s)
included in the combination. Cost of manufacturing or provision of
services for the purposes of this paragraph will be determined in
accordance with generally accepted accounting
principles.
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1.09
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“NON-OBESITY NET SALES”
shall mean NET SALES from any NON-OBESITY PRODUCT.
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1.10
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“NON-OBESITY PRODUCTS”
shall mean any LICENSED PRODUCT, LICENSED PROCESS or LICENSED
SERVICE used for the treatment of any indication other than
obesity.
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1.11
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“OBESITY NET SALES”
shall mean NET SALES from any LICENSED PRODUCT, LICENSED PROCESS or
LICENSED SERVICE for the treatment of obesity.
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1.12
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“OBESITY PRODUCTS” shall
mean any LICENSED PRODUCT, LICENSED PROCESS or LICENSED SERVICE
used for the treatment of obesity.
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1.13
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“PATENT RIGHTS” shall
mean the patents, patent applications listed in APPENDIX A (such
patents hereinafter collectively referred to as
“PATENTS”), 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 said PATENTS), re-examinations,
reissues, substitutions, or extensions thereof and patents issuing
therefrom in the United States and non-U.S. jurisdictions.
Notwithstanding the foregoing or anything else to the contrary in
this AGREEMENT, PATENT RIGHTS shall not include those patents
and/or patent applications which, during the term of this
AGREEMENT, cease to be PATENT RIGHTS pursuant to Section 6.01 or
Section 6.02. The term “PATENT RIGHTS” shall also
include any “Improvements”, as such term is defined in
the CONSULTING AGREEMENT.
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1.14
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“PATENT RIGHTS EXPENSES”
shall mean all patent-related expenses (including, but not limited
to, filing fees, maintenance fees, and reasonable fees and expenses
of patent counsel) incurred in connection with the PATENT
RIGHTS.
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1.15
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“STOCK OPTION AGREEMENT”
shall have the meaning given in Section 3.01(a).
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1.16
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“SUBLICENSE” and
“SUBLICENSE AGREEMENT” shall mean, and include without
limitation, any relationship/agreement in which a THIRD PARTY gains
any rights—temporary or otherwise—to any of the rights
granted by DANTE to OREXIGEN under this AGREEMENT (including, but
not limited to, OREXIGEN 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.
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1.17
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“SUBLICENSE REVENUES”
shall mean any and all initial upfront fees, license fees, option
fees, milestone payments, and other amounts (other than running
royalties on NET SALES of LICENSED PRODUCTS) payable to OREXIGEN
(and/or any of SUBLICENSEES, as the case may be) under a SUBLICENSE
to any of the licenses granted by DANTE to OREXIGEN under this
AGREEMENT, but excluding any payments that are (a) reimbursements
of documented research and development costs and expenses; (b)
reimbursement of cost of goods directly relating to LICENSED
PRODUCTS supplied by OREXIGEN to such SUBLICENSEE; (c) loans
granted to OREXIGEN by such SUBLICENSEE; (d)
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reimbursement
of documented costs directly related to pursuit of patent
protection and/or maintenance of patents for PATENT RIGHTS and/or
OREXIGEN PATENT RIGHTS; or (e) an equity investment by a
commercial THIRD PARTY (but solely to the extent that such
investment is at a price equal to or less than one hundred percent
(100%) of the fair market value of stock sold or otherwise
transferred in such investment). It is agreed that [***] shall not
receive from [***] for any SUBLICENSE under this AGREEMENT, without
the express prior written permission of DANTE, such approval not to
be unreasonably withheld.
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1.18
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“TERRITORY” shall mean
the world.
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1.19
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“THIRD PARTY” means any
individual or other entity other than DANTE and/or
OREXIGEN.
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1.20
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“VALID CLAIM” shall mean
(i) an issued and unexpired claim within the PATENT RIGHTS
that has not been permanently revoked or held 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 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 refilling
of such application contained in the PATENT RIGHTS in the country
in which any such product or part thereof is made, used or
sold.
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1.21
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Where appropriate, words denoting a
singular number only shall include the plural and vice
versa.
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1.22
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Certain other defined terms shall
have the meanings given them elsewhere in this
AGREEMENT.
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2.01
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DANTE hereby grants to OREXIGEN and
OREXIGEN hereby accepts from DANTE, subject to the terms and
conditions of this AGREEMENT, the exclusive right and
sublicenseable license for the FIELD OF USE in the TERRITORY to
practice under the PATENT RIGHTS to develop, make, have made,
import, use, lease, offer for sale, sell, and distribute LICENSED
PRODUCTS for the FIELD OF USE in the TERRITORY only, to develop,
make, have made, import, use, lease, offer for sale, sell, and
distribute LICENSED PROCESSES in/for the FIELD OF USE in the
TERRITORY, and/or to develop, make, have made, perform, provide,
import, use, lease, offer for sale, sell, and distribute LICENSED
SERVICES in the FIELD OF USE in the TERRITORY only until the end of
the term for which the PATENT RIGHTS are granted unless this
AGREEMENT shall be sooner terminated according to the terms
hereinafter provided.
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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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- 5 -
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2.02
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All
SUBLICENSES shall be subject to the terms and conditions of this
AGREEMENT, shall be no less favorable to or protective of DANTE
than this AGREEMENT except as expressly stated in this AGREEMENT,
and shall not be further sublicenseable without the express written
approval of DANTE, such approval not to be unreasonably withheld.
All SUBLICENSES will be assigned to DANTE in the event the
AGREEMENT is terminated, subject to DANTE’s approval, such
approval not to be unreasonable withheld or delayed. OREXIGEN shall
use commercially reasonable efforts to enforce the terms of the
SUBLICENSE agreements. OREXIGEN further agrees to provide DANTE
with a copy of all SUBLICENSES within thirty (30) days of
execution of each subject SUBLICENSE.
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ARTICLE 3
– LICENSE FEE, ROYALTIES AND OTHER FEES
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3.01
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In
consideration of the rights granted to OREXIGEN pursuant to this
AGREEMENT and subject to the terms and conditions of this
AGREEMENT, OREXIGEN agrees to pay or otherwise compensate DANTE as
follows:
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(a)
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Equity Consideration
. OREXIGEN shall grant
to DANTE stock options to purchase one hundred forty-six thousand
eight hundred ninety-seven (146,897) shares of OREXIGEN COMMON
STOCK as represent, on a FULLY DILUTED BASIS, an amount not less
than [***] percent ([***]%) of OREXIGEN COMMON STOCK outstanding at
the time of execution of this AGREEMENT (hereinafter referred to as
the “DANTE OPTIONS”). OREXIGEN shall issue and deliver
the DANTE OPTIONS to DANTE within thirty (30) days of the
EFFECTIVE DATE, DANTE and OREXIGEN shall enter into the Stock
Option Agreement, the form of which is attached as Appendix B
(the “STOCK OPTION AGREEMENT”).
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(b)
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Upfront Royalty
. OREXIGEN shall pay
DANTE a one-time, noncreditable, non-refundable payment of one
hundred thousand dollars ($100,000), payable as follows:
(i) upon execution of this AGREEMENT, OREXIGEN shall pay DANTE
the sum of twenty-five thousand dollars ($25,000); and (ii) upon
execution of this AGREEMENT, OREXIGEN shall deliver the sum of
seventy-five thousand dollars ($75,000) into an OREXIGEN escrow
account, which sum shall be released to DANTE upon OREXIGEN’S
receipt of confirmation that John S. Nagle has filed an assignment
of the PATENT RIGHTS with the Patent and Trademark
Office.
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(c)
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Royalty on NET SALES of LICENSED
PRODUCTS, LICENSED PROCESSES, and LICENSED SERVICES
. At the times and in
the manner set forth hereinafter, OREXIGEN (and/or appertaining
SUBLICENSEES, as the case may be) shall pay to DANTE non-refundable
running royalties (hereinafter such running royalty referred to
collectively as the “RUNNING ROYALTY”) of: (i) [***]
percent
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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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- 6 -
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([***]%) on
OBESITY NET SALES, and (ii) [***] percent ([***]%) on NON-OBESITY
NET SALES. Notwithstanding the foregoing, if OREXIGEN (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 PATENT RIGHTS in the FIELD OF USE or in order to
develop, make, have made, use, import, offer for sale, sell,
import, export or provide NON-OBESITY PRODUCTS, then OREXIGEN
(and/or appertaining SUBLICENSEES, as the case may be) shall be
entitled to credit its/their payment of additional running
royalties to such THIRD PARTY(ies), if any, on NON-OBESITY NET
SALES against the RUNNING ROYALTY for the subject NON-OBESITY
PRODUCTS in the appertaining country(ies) during the appertaining
time period, provided that in no event shall the amount otherwise
payable to DANTE as RUNNING ROYALTY on NON-OBESITY NET SALES be
reduced to less than [***] percent ([***]%) for the subject
NON-OBESITY PRODUCTS in the appertaining country(ies) during the
appertaining time period. The RUNNING ROYALTY on OBESITY NET SALES
shall [***] under this Section 3.01(c).
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(d)
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Milestone Payments
. OREXIGEN (and/or
appertaining SUBLICENSEES, as the case may be) shall pay DANTE a
one-time, noncreditable, non-refundable payment of one million
dollars ($1,000,000) within [***].
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(e)
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Royalty on SUBLICENSE
REVENUES .
OREXIGEN (and/or appertaining SUBLICENSEES, as the case may be)
shall pay to DANTE a royalty of [***] percent ([***]%) on
SUBLICENSING REVENUES.
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(f)
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Consulting Agreement
. Concurrently with the
execution of this AGREEMENT, OREXIGEN and DANTE shall enter into a
Consulting Agreement, the form of which is attached hereto as
Appendix C (the “CONSULTING
AGREEMENT”).
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3.02
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All
payments due from OREXIGEN (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. All past due payments shall bear interest at the annual
rate of [***] percent ([***]%) legal from the due date of such
payment until paid. The payment of such interest and late fees
shall not foreclose DANTE from exercising any other rights he may
have as a consequence of the lateness of any payment.
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3.03
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No
multiple royalties on NET SALES shall be payable to DANTE on a
single LICENSED PRODUCT because its manufacture, use, lease, sale
or practice are or shall be covered by more than one of the PATENT
RIGHTS.
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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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- 7 -
ARTICLE 4
– DUE DILIGENCE REQUIREMENTS
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4.01
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No
multiple royalties on NET SALES shall be payable to DANTE on a
single LICENSED PRODUCT because its manufacture, use, lease, sale
or practice are or shall be covered by more than one of the PATENT
RIGHTS and/or OREXIGEN PATENT RIGHTS.
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4.02
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OREXIGEN shall use commercially
reasonable efforts to bring LICENSED PRODUCTS to market through a
thorough, vigorous and diligent program for exploitation of the
PATENT RIGHTS and OREXIGEN PATENT RIGHTS, and to continue active,
diligent marketing efforts for LICENSED PRODUCTS throughout the
life of this AGREEMENT.
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4.03
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During the term of this AGREEMENT,
OREXIGEN will submit [***] progress reports to DANTE as set forth
in Section 5.02. DANTE shall have the right to request [***]
([***]) [***] to discuss such information with representatives of
OREXIGEN at OREXIGEN’S offices. As part of exercising such
commercially reasonable efforts, OREXIGEN will consider filing an
NDA for LICENSED PRODUCTS, provided that such a filing is
appropriate, given the medical effectiveness of the particular
LICENSED PRODUCT, the market opportunity therefor, competitive
conditions, time to approval, cost of conducting reasonably
anticipatory clinical trials and other commercially reasonable
factors.
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ARTICLE 5
– REPORTS AND RECORDS
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5.01
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OREXIGEN shall keep full, true and
accurate books of accounts and other records containing all
particulars which may be necessary to properly ascertain and verify
the amounts payable to DANTE hereunder and shall require
SUBLICENSEES, as the case may be, to do the same. Said books of
account shall be kept at OREXIGEN’s (and/or
SUBLICENSEES’) principal place of business or the principal
place of business of the appropriate division of OREXIGEN (and/or
SUBLICENSEE) to which this AGREEMENT relates. Said books and the
supporting data shall be open at all reasonable times for [***]
([***]) years following the end of the calendar year to which they
pertain, to the inspection of DANTE or its agents for the purpose
of verifying the OREXIGEN’s (and/or SUBLICENSEE’s)
royalty statement or compliance in other respects with this
AGREEMENT. Should such inspection lead to the discovery of a
greater than [***] percent ([***]%) discrepancy in reporting,
OREXIGEN agrees to pay the full cost of such inspection in addition
to any amounts due to DANTE.
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5.02
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OREXIGEN shall report the status of
development of each LICENSED PRODUCT [***] to DANTE by [***]. Such
report shall include descriptions of OREXIGEN’s (and/or
SUBLICENSEES’s plans and commercially reasonable estimated
timeframes for testing, development, governmental approvals and
marketing/sale of each LICENSED PRODUCT.
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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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- 8 -
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5.03
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After the first commercial sale of a
LICENSED PRODUCT, and in addition to the reports required under
Section 5.02, OREXIGEN shall render to DANTE prior to [***] a
written account of the NET SALES of LICENSED PRODUCTS made during
the prior [***] period ending [***], respectively, and shall
simultaneously pay to DANTE the royalties due on such NET SALES in
United States dollars. Reports tendered shall include the
calculation of royalties by product by country. Further, OREXIGEN
shall render to DANTE prior to [***] a written account of royalties
on SUBLICENSE REVENUES due to DANTE for the prior [***] period
ending [***], respectively, and shall simultaneously pay to DANTE
the royalties due on such NET SALES in United States
dollars.
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(a)
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DANTE shall use his reasonable best
efforts to have the prosecution of the PATENT RIGHTS transferred to
OREXIGEN’S patent firm (Knobbe Martens Olson & Bear LLP,
attn: Ned A. Israelsen, 550 West C Street, Suite 1200, San
Diego, CA 92101, (619) 235-8550 (voice), (619) 235-0176
(fax), email nisraelsen@kmob.com) within [***] ([***]) days of the
EFFECTIVE DATE so that OREXIGEN may assume primary responsibility
for all activities associated with the prosecution and maintenance
of the PATENT RIGHTS. OREXIGEN will use reasonable commercial
efforts to file, prosecute and maintain the PATENT RIGHTS during
the term of this AGREEMENT. OREXIGEN will keep DANTE advised as to
all developments with respect to any applicable divisional,
continuation, continuation-in-part and reissue application(s)
within the scope of the PATENT RIGHTS. OREXIGEN shall keep DANTE
advised as to the status of the PATENT RIGHTS and OREXIGEN’s
designated patent attorneys will provide DANTE, in a timely manner,
with copies of all official documents and correspondence relating
to the prosecution, maintenance, and validity of the PATENT RIGHTS.
OREXIGEN shall consult with DANTE in such prosecution and
maintenance, shall diligently seek advice of DANTE on all matters
pertaining to the PATENT RIGHTS, shall diligently seek strong and
broad claims under the PATENT RIGHTS, and shall not abandon
prosecution of any PATENT RIGHTS or any of the claims of the PATENT
RIGHTS without first notifying DANTE in a timely manner of
OREXIGEN’s intention and reason therefore, and providing
DANTE with reasonable opportunity to assume responsibility for
prosecution and maintenance of the appertaining PATENT RIGHTS
(which thereafter shall be subject to the provisions of
Section 6.02(b) as regards status as PATENT RIGHTS and
LICENSED PRODUCTS, LICENSED PROCESSES, and LICENSED SERVICES and
OREXIGEN’s rights therein). All decisions with respect to the
prosecution of the PATENT RIGHTS by OREXIGEN pursuant to
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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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this
Section 6.01(a) shall be made by OREXIGEN, subject to the
approval of DANTE which approval shall not be unreasonably withheld
or delayed. OREXIGEN’s obligations under this
Section 6.01(a) shall include, without limitation, an
obligation to inform DANTE in a timely manner (no less than [***]
([***]) days prior to the appertaining filing deadlines) that
OREXIGEN will not pursue patents in any non-US country so that
DANTE may pursue such patents if it so desires in which case from
the date of such filing of such patent applications by DANTE shall
not be considered PATENT RIGHTS and OREXIGEN shall be deemed to
have forfeited all rights under this AGREEMENT to such patent
applications and resulting patents. (APPENDIX A shall be deemed to
be so amended.) For avoidance of doubt, it is understood that
OREXIGEN shall assume direct and full responsibility for payment of
expenses it incurs as a result of his assumption of responsibility
for prosecution of PATENT RIGHTS under this
Section 6.01(a).
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(a)
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During the term of this AGREEMENT,
payment of all PATENT RIGHTS EXPENSES shall be the responsibility
of OREXIGEN, whether such fees and costs were incurred before or
after the EFFECTIVE DATE of this AGREEMENT. Notwithstanding
anything to the contrary in this AGREEMENT, except as OREXIGEN
declines interest in non-US patent pursuit, OREXIGEN shall be
responsible for all PATENT RIGHTS EXPENSES associated with the
preparation and filing of the PCT application(s) contained within
the PATENT RIGHTS as well as all PATENT RIGHTS EXPENSES associated
with pursuit and maintenance of the PATENT RIGHTS. Within thirty
(30) days of the EFFECTIVE DATE of this AGREEMENT, OREXIGEN
agrees to reimburse DANTE for PATENT RIGHTS EXPENSES (not to exceed
forty thousand dollars ($40,000)) which were incurred by DANTE, and
for which attorney invoices were received and processed by DANTE,
before the EFFECTIVE DATE.
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(b)
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If
OREXIGEN decides to discontinue the financial support of the
prosecution or maintenance of a subject PATENT APPLICATION or
patent falling within the scope of PATENT RIGHTS, OREXIGEN will
give DANTE timely written notice at least two (2) months in
advance of the effective date of OREXIGEN’s decision and
DANTE will be free to continue prosecution or maintain any such
application(s)/patents, and to maintain any protection issuing
thereon in the U.S. and in any foreign country at DANTE’s
sole expense. In such instances, from the date of DANTE’s
receipt of such written notice from OREXIGEN, such patent and/or
DANTE PATENT APPLICATION shall no longer be considered to fall
within the definition of PATENT RIGHTS (APPENDIX A shall be deemed
to be so amended) and OREXIGEN shall forfeit all rights under this
AGREEMENT to the subject issued patent(s) and/or subject
DANTE
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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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PATENT
APPLICATION and patent(s) arising from such PATENT APPLICATION.
Accordingly, DANTE shall be free, at his sole discretion to license
said patent(s) and patent application(s) to any THIRD PARTY or
otherwise dispose of such patent(s) and patent applications(s) as
it deems appropriate.
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6.03
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OREXIGEN agrees to mark the LICENSED
PRODUCTS (as the case may be), and/or their containers, labels,
and/or other packaging, in such a manner as to conform to the
patent laws and practices of the country of manufacture or sale, as
appropriate.
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ARTICLE 7
– INFRINGEMENT OF THIRD-PARTY RIGHTS
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7.01
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In
the event that DANTE or OREXIGEN is charged with infringement of a
patent by a THIRD PARTY or is made a party in a civil action as a
result of the activity of OREXIGEN and/or a SUBLICENSEE (and not
from the activity of DANTE or his AFFILIATES other than the
granting of this license to OREXIGEN) as a result (directly or
indirectly) of the licenses granted hereunder to OREXIGEN,
OREXIGEN:
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(a)
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must defend and/or settle any such
claim of infringement or civil action;
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(b)
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must assume all costs, expenses,
damages, and other obligations, for payments incurred as a
consequence of such charges of infringement and/or civil
action;
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(c)
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must indemnify and hold DANTE
harmless from any and all damages, losses, liability, and costs
resulting from a charge of infringement or civil action which shall
be brought against DANTE and attributable to technology added to,
incorporated into or sold with a LICENSED PRODUCT by OREXIGEN,
and/or SUBLICENSEE (as the case may be) or to manufacturing
processes utilized by OREXIGEN or SUBLICENSEE (as the case may be);
and
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(d)
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may, if such claim of infringement
or civil action shall be based on patent claims contained in any
pending or issued patent included in the PATENT RIGHTS, terminate
this AGREEMENT effective immediately upon DANTE’s receipt of
written notice of termination.
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7.02
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DANTE will give OREXIGEN reasonable
assistance, at OREXIGEN’s expense, in the defense of any such
infringement charge or lawsuit, as may be reasonably required.
OREXIGEN shall reimburse DANTE for such expenses within [***]
([***]) days of receiving an invoice for the same.
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ARTICLE 8
– INFRINGEMENT OF PATENT RIGHTS BY THIRD
PARTIES
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8.01
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Each party to this AGREEMENT is
obligated to inform the other promptly in writing of any alleged
infringement of which it becomes aware and of any
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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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available
evidence of infringement by a THIRD PARTY of any patents within the
PATENT RIGHTS.
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8.02
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If
during the term of this AGREEMENT, OREXIGEN becomes aware of any
alleged infringement by a THIRD PARTY, OREXIGEN shall have the
right, but not the obligation, to either:
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(a)
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settle the infringement suit by
sub-licensing the alleged infringer or by other means;
or
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(b)
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prosecute at its own expense any
infringement of the PATENT RIGHTS. In the event OREXIGEN prosecutes
such infringement of PATENT RIGHTS, OREXIGEN may, for such
purposes, request to use the name of DANTE as party plaintiff.
DANTE, at his sole discretion, may agree to become a party
plaintiff, and all costs associated therewith shall be borne by
OREXIGEN.
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8.03
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In
the event that OREXIGEN undertakes the enforcement and/or defense
of the PATENT RIGHTS by litigation, including any declaratory
judgment action, the total cost of any such action commenced or
defended solely by OREXIGEN shall be borne by OREXIGEN. Any
recovery of damages by OREXIGEN as a result of such action shall be
applied first in satisfaction of any unreimbursed expenses and
attorneys’ fees of OREXIGEN relating to the action, and
second in satisfaction of unreimbursed legal expenses and
attorneys’ fees of DANTE, if any, relating to the action. If
applicable, OREXIGEN shall receive an amount equal to its lost
profits, a reasonable royalty on sales of the infringer, or other
measure of damages the court shall have applied, less a reasonable
approximation of the royalties that OREXIGEN would have owed to
DANTE on NET SALES that may have been made by OREXIGEN but,
instead, were lost to the infringer, which amount shall be promptly
paid by OREXIGEN to DANTE. Any balance remaining from such recovery
shall be distributed between OREXIGEN and DANTE, with OREXIGEN
receiving [***] percent ([***]%) and DANTE receiving [***] percent
([***]%).
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8.04
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In
the event OREXIGEN does not undertake action to prevent the
infringing activity within [***] ([***]) months of having been made
aware and notified thereof, DANTE shall have the right, but not the
obligation, to prosecute at his own expense any such infringements
of the PATENT RIGHTS and, in furtherance of such right, DANTE may
use the name of OREXIGEN as a party plaintiff in any such suit
without expense to OREXIGEN. The total cost of any such
infringement action commenced or defended solely by DANTE shall be
borne by DANTE. Any recovery of damages by DANTE for any
infringement shall be applied first in satisfaction of any
unreimbursed expenses and attorneys’ fees of DANTE relating
to the suit, and second toward reimbursement of OREXIGEN’s
reasonable expenses, including reasonable attorneys’ fees,
relating to the suit. Any balance remaining from such recovery
shall be distributed between
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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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OREXIGEN and
DANTE, with DANTE receiving [***] percent ([***]%) and OREXIGEN
receiving [***] percent ([***]%).
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8.05
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In
any infringement suit instituted by either party to enforce the
PATENT RIGHTS, the other party hereto shall, at the request and
expense of the party initiating such suit, reasonably cooperate in
all respects and, to the extent reasonably possible, have its
employees testify when requested and make available relevant
records, papers, information, samples, specimens, and the
like.
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8.06
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OREXIGEN has the sole right in
accordance with the terms and conditions herein to sublicense any
LICENSED PRODUCT to an alleged infringer under the PATENT RIGHTS in
the TERRITORY in order to avoid infringement in the
future.
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8.07
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Any
of the foregoing notwithstanding, if at any time during the term of
this AGREEMENT any of the PATENT RIGHTS are held invalid or
unenforceable in a decision which is not appealable or is not
appealed within the time allowed, OREXIGEN shall have no further
obligations to DANTE with respect to its future use or sale of any
LICENSED PRODUCT, LICENSED PROCESS, and/or LICENSED SERVICE covered
solely by such PATENT RIGHTS, including the obligation of paying
royalties. For avoidance of doubt it is understood and agreed that
in such event, OREXIGEN shall not have any damage claim or any
claim for refund or reimbursement against DANTE for any amounts
previously paid to DANTE under this AGREEMENT, including, but not
limited to, the payment of DANTE STOCK.
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ARTICLE 9
– GOVERNMENT CLEARANCE, PUBLICATION
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9.01
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Insofar as such clearance is
required, OREXIGEN agrees to use its best efforts to have the
LICENSED PRODUCTS cleared for marketing in those countries in which
OREXIGEN intends to sell LICENSED PRODUCTS by the responsible
government agencies requiring such clearance. To accomplish said
clearances at the earliest possible date, OREXIGEN agrees to file
or have filed any necessary data with said government agencies as
quickly as commercially reasonable. Should this AGREEMENT terminate
in accordance with Section 10.02, 10.03, or 10.04, LICENSEE
shall, within [***] ([***]) days following such termination and at
its own expense, assign to DANTE its full interest and title in and
full documentation of (i) all market clearance applications
(including all data relating thereto) which relate to LICENSED
PRODUCTS, LICENSED PROCESSES, and/or LICENSED SERVICES and
(ii) all data that could relate to market clearance
applications for LICENSED PRODUCTS, LICENSED PROCESSES, and/or
LICENSED SERVICES, including, but not limited to, all in
vitro and in vivo pre-clinical data, pharmacology data,
toxicology data, human data and the like. Notwithstanding anything
to the contrary in this AGREEMENT, effective upon receipt of such
information, data, etc. by DANTE, such information shall not
be considered the confidential information of OREXIGEN under
Article 11 but instead shall henceforth be considered the
confidential information of DANTE
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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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and subject to
the provisions of restricted use and non-disclosure set forth in
Article 11.
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9.02
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It
is understood and agreed that the right of publication/presentation
of the PATENT RIGHTS shall reside with DANTE, but OREXIGEN shall
also have the right to publish and/or co-author any
publication/presentation on the PATENT RIGHTS in accordance with
academic custom. In the event that either DANTE or OREXIGEN desires
to so publish/present, the party desiring publication shall notify
the other party of its desire to publish/present at least thirty
(30) days in advance of each subject publication/presentation
and shall furnish to the non-publishing party a written description
of the subject matter of the publication/presentation in order to
permit the non-publishing party to review and comment thereon, such
obligation of notification of the publishing/presenting party and
associated right of the non-publishing/presenting party to review
and comment thereon to expire upon the [***] ([***]) anniversary of
the Effective Date.
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ARTICLE 10
– DURATION AND TERMINATION
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10.01
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This AGREEMENT shall become
effective upon the EFFECTIVE DATE, and unless sooner terminated in
accordance with any of the provisions herein, shall remain in full
force and effect for the life of the last-to-expire of the patents
included in the PATENT RIGHTS.
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10.02
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Either party may immediately
terminate this AGREEMENT for fraud, willful misconduct, or illegal
conduct of the other party, in all such cases with respect to the
subject matter of this AGREEMENT, upon written notice of same to
that other party.
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10.03
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OREXIGEN may terminate this
AGREEMENT by giving DANTE written notice at least three
(3) months prior to the effective date of such termination. It
is understood that OREXIGEN shall remain responsible for the timely
payment of all amounts due DANTE under this AGREEMENT through the
effective date of the termination.
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10.04
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If
either party fails to fulfill any of its material obligations under
this AGREEMENT, the non-breaching party may terminate this
AGREEMENT, upon written notice to the breaching party, as provided
below. Such notice must contain a full description of the event or
occurrence constituting a breach of the AGREEMENT. The party
receiving notice of the breach will have the opportunity to cure
that breach within thirty (30) days of receipt of notice. If
the breach is not cured within that time, the termination will be
effective as of the thirty-first (31st) day after receipt of
notice. A party’s ability to cure a breach will apply only to
the first [***] ([***]) breaches properly noticed under the terms
of this AGREEMENT, regardless of the nature of those breaches. Any
subsequent breach by that party will entitle the other party to
terminate this AGREEMENT upon receipt of notice by the breaching
party, where such notice must contain a
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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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full
description of the event or occurrence constituting a breach of
this AGREEMENT.
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10.05
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If
during the term of this AGREEMENT, OREXIGEN shall become bankrupt
or insolvent or if the business of OREXIGEN shall be placed in the
hands of a receiver or trustee, whether by the voluntary act of
OREXIGEN or otherwise, or if OREXIGEN shall cease to exist as an
active business, this AGREEMENT shall immediately terminate and all
PATENT RIGHTS and any rights granted hereunder by DANTE to OREXIGEN
shall immediately be returned and transferred to DANTE.
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10.06
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Notwithstanding anything to the
contrary in this AGREEMENT, neither expiration nor any termination
of this AGREEMENT shall remove any financial obligations to DANTE
which OREXIGEN incurred under this AGREEMENT prior to and as of the
effective date of any expiration or termination.
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10.07
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On
or before the effective date of any expiration or termination of
this AGREEMENT, OREXIGEN shall cease the manufacture, use,
practice, lease, and sale, offering, distribution, and other
commercialization of LICENSED PRODUCTS, LICENSED PROCESSES, and
LICENSED SERVICES.
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10.08
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Within thirty (30) days of any
expiration or termination of this AGREEMENT, OREXIGEN shall
(i) return to DANTE or destroy, as directed by DANTE, all
information, data, and any relevant materials provided to OREXIGEN
during the term of this AGREEMENT and (ii) destroy all
LICENSED PRODUCTS in a safe and legal manner. Further, OREXIGEN
shall provide DANTE with a written statement signed by an
authorized representative of OREXIGEN certifying the destruction of
all LICENSED PRODUCTS in a safe and legal manner, as well as the
destruction of said information data, and relevant materials if
such instructions for destruction are given by DANTE.
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ARTICLE 11
– CONFIDENTIALITY
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11.01
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DANTE and OREXIGEN each agree to
treat any confidential information disclosed to it by the other
party under this AGREEMENT with reasonable care and to avoid
disclosure of such information to any other person, firm or
corporation, except AFFILIATES bound by the obligations of
confidentiality and restricted use set forth in this
Article 11, and either party shall be liable for unauthorized
disclosure or failure to exercise such reasonable care. Further,
the receiving party will not use the disclosing party’s
confidential information other than for the benefit of the parties
hereto and relating to this AGREEMENT. These obligations of
non-disclosure and restricted use shall remain effect for each
subject disclosure of confidential information for a period of time
of [***] ([***]) years from such disclosure, however, neither party
shall have an obligation, with respect to confidential information
disclosed to it, or any part thereof, which:
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(a)
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is
already known to the party at the time of the
disclosure;
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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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(b)
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becomes publicly known without the
wrongful act or breach of this AGREEMENT by the party;
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(c)
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is
rightfully received by the party from a THIRD PARTY on a
non-confidential basis;
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(d)
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is
subsequently and independently developed by employees of the party
who had no knowledge of the information, as verified by written
records;
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(e)
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is
approved for release by prior written authorization of the party
disclosing the information; or
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(f)
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is
disclosed pursuant to any judicial or government request,
requirement or order, provided that the party so disclosing takes
reasonable steps to provide the other party sufficient prior notice
in order to contest such request, requirement or order and provided
and provided that such disclosed confidential information otherwise
remains subject to the obligations of confidentiality set forth in
this Article 11.
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11.02
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DANTE and OREXIGEN agree that any
information to be treated as confidential information under this
Article 11 must be disclosed in writing or other tangible
medium and must be clearly marked “CONFIDENTIAL”.
Confidential information disclosed orally must be summarized and
reduced to writing
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