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EXHIBIT 10.7
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
BETWEEN
Oregon Health & Science University
AND
Orexigen
Table of Contents
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1.
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Background
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2.
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Definitions
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3.
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Grant of Rights
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4.
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Sublicensing
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5.
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Reserved Government Rights
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6.
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Royalties and Reimbursements
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7.
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Record Keeping
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8.
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Reports on Progress, Sales, and
Payments
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9.
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Performance
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10.
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Patent Filing, Prosecution, and
Maintenance
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11.
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Infringement and Patent Enforcement
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12.
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Negation of Warranties and
Indemnification
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13.
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Term, Termination, and Modification of
Rights
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Signature Page with Addresses
Exhibit A: Milestones
Exhibit B: Common Stock Purchase Agreement
This License Agreement is
made and entered into on this 27 th day of June, 2003 (hereinafter "
Effective Date ") by and between Oregon Health & Science
University (hereinafter " OHSU "), having offices at 2525 SW
1 st Ave,
Portland, Oregon 97201, and Orexigen Therapeutics, Inc.
(hereinafter " LICENSEE "), a Delaware corporation having
offices at 28202 Cabot Road, Suite 200, Laguna Niguel, CA
92677.
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1.
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BACKGROUND
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1.01
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In the course of fundamental research programs at
OHSU inventions were conceived which relate to:
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1.01.1 [***]
(hereinafter: Screening Patent )
1.01.2 [***] and [***]
(hereinafter: Mouse Patent )
1.01.3 [***] (hereinafter:
Therapeutic Patent )
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The intellectual property rights resulting from
these inventions and covered under this Agreement may be
subject to the conditions set forth in 37 CFR
Part 401.
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1.02
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OHSU is owner of certain right, title
and interest in inventions related to the Screening Patent ,
Mouse Patent , and claims an interest in the Therapeutic
Patent , and OHSU desires to license the Screening
Patent and Mouse Patent to LICENSEE and assign
ownership of the Therapeutic Patent to LICENSEE .
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1.03
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LICENSEE desires to obtain the licenses
to and assignment of the patent rights for public use and benefit
by using said patent rights,
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1.04
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OHSU desires to grant license and
assignment under those rights to LICENSEE to develop and use
products and/or processes or sell products for public use and
benefit that utilize the inventions.
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2.
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DEFINITIONS
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2.01
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" First Commercial Sale " means the
initial transfer by or on behalf of LICENSEE or its
sublicensee of Licensed Products or Screening
Products in exchange for cash or some equivalent to which value
can be assigned for the purpose of determining Net Sales
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2.02
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" Government " means the government of the
United States of America.
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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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2.03
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" Licensed Mouse Patent Field of Use "
shall mean the breeding and use of MICE for LICENSEE
’s own internal research purposes for drug development and
characterization to develop therapeutic agents, compositions,
and/or formulations to control hunger and/or feeding behavior. The
Licensed Mouse Patent Field of Use specifically includes
brain tissue, and more specifically brain slices including the
arcuate nucleus, for analysis of the effects of potential
therapeutic materials, compositions and formulations upon the
defined neuronal circuits affecting feeding behavior and/or
feelings of hunger or satiety. The Licensed Mouse Patent Field
of Use specifically excludes DNA extracted from MICE ,
or the development or use of any cells, cell lines or subcellular
fractions of MICE , particularly as a product for sale or
distribution.
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2.04
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" Licensed Mouse Patent Rights " shall
mean [***].
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2.05
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" Licensed Mouse Patent Territory " shall
mean facilities operated by or on behalf of LICENSEE in the
United States.
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2.06
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" Licensed Screening Patent Field of Use "
shall mean screening for drug development and characterization to
develop therapeutic agents, compositions, and/or formulations to
control hunger and/or feeding behavior for LICENSEE ’s
own internal research purposes.
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2.07
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" Licensed Screening Patent Rights " shall
mean:
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2.07.1 [***], all divisions which claim priority
to this application, and all patents issuing from such
applications, divisions, and continuations, and in any reissues,
reexaminations, and extensions of all such patents;
2.07.2 to the extent that the following contain one or more
claims fully supported in 2.07.1 above: said claims (i) in
continuations-in-part of 2.07.1 above; (ii) in all divisions
and continuations of these continuations-in-part; (iii) in all
patents issuing from such continuations-in-part, divisions, and
continuations; and (iv) in any reissues, reexaminations, and
extensions of all such patents; and
2.07.3 to the extent that the following contain one or more
claims fully supported in 2.07.1 above: said claims in all
counterpart foreign applications and patents to 2.07.1 and 2.07.2
above.
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Licensed Screening Patent Rights
shall not include (2.07.2) or (2.07.3) above to the extent that
they contain one or more claims directed to new matter that is not
fully supported in (2.07.1) above. Nor shall Licensed Screening
Patent Rights include any claims to a composition of
matter.
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2.08
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"Licensed Screening Patent Territory"
shall mean worldwide.
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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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2.09
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"Therapeutic Patent Field of Use" means
discovering and developing therapeutic agents, compositions, and/or
formulations to control hunger and/or feeding behavior.
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2.10
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"Assigned Therapeutic Patent
Rights"
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2.10.1 The inventions disclosed in [***], all
regular utility applications, continuations, and divisions which
claim priority to this application, and all patents issuing from
such applications, divisions, and continuations, and in any
reissues, reexaminations, and extensions of all such patents, it
being understood that the referenced provisional application has no
claims at the current time and that the specification of the
provisional application will likely be supplemented and modified in
the expected regular utility application claiming priority
therefrom;
2.10.2 to the extent that the following contain one or more
claims fully supported in (2.10.1) above: said claims (i) in
continuations-in-part of (2.10.1) above; (ii) in all divisions and
continuations of these continuations-in-part; (iii) in all
patents issuing from such continuations-in-part, divisions, and
continuations; and (iv) in any reissues, reexaminations, and
extensions of all such patents; and
2.10.3 to the extent that the following contain one or more
claims fully supported in (2.10.1) above: said claims in all
counterpart foreign applications and patents to (2.10.1) and
(2.10.2) above.
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Assigned Therapeutic Patent Rights
shall not include (2.10.2) or (2.10.3) above to the extent that
they contain one or more claims directed to new matter that is not
fully supported in (2.10.1) above.
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2.11
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"Therapeutic Patent Territory" shall
mean worldwide.
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2.12
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" Patent Rights " means Licensed
Screening Patent Rights , Licensed Mouse Patent Rights ,
and Assigned Therapeutic Patent Rights .
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2.13
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" Licensed Product(s) " means tangible
materials which, in the course of manufacture, use, or sale would,
in the hands of an unlicensed third party, infringe one or more
Valid Claims of the Assigned Therapeutic Patent
Rights .
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2.14
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" Licensed Process(es) " means methods
which, in the course of being practiced would, in the absence of
this Agreement , infringe one or more pending or issued
claims of the Patent Rights that have not been held invalid
or unenforceable by an unappealed or unappealable judgment of a
court of competent jurisdiction.
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2.15
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" Mouse " or " Mice " shall mean
[***] mice and the derived brain slice preparation for
electrophysiological measurements was described in [***]
.[***]
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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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2.16
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" Net Sales " means the total gross
receipts for sales of Licensed Products or Screening
Products by or on behalf of LICENSEE or its
sublicensees, whether invoiced or not, less returns and allowances
actually granted, packing costs, insurance costs, freight out,
taxes or excise duties imposed on the transaction (if separately
invoiced), and wholesaler and cash discounts in amounts customary
in the trade.
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2.17
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" Screening Product(s) " means products
demonstrated to have an activity using the Licensed Screening
Patent Rights or the Licensed Mouse Patent Rights that
is used to support regulatory approval.
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2.18
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" Valid Claim " means: (i) a claim of
any issued patent in the Patent Rights , which has not been
disclaimed, revoked or held unpatentable, invalid or unenforceable
by a final decision of a court or other governmental agency of
competent jurisdiction, which decisions is unappealable or
unappealed within the time allowed for appeal, and which claim is
otherwise enforceable, or (ii) a claim of a patent application
in the Patent Rights that is pending in good faith and has
not been on file in a substantially comparable form in a given
country with the applicable patent office for more than [***]
([***]) years from the earliest date from which the patent
application was filed or claims priority in such
country.
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3.
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GRANT OF RIGHTS
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3.01
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OHSU hereby grants and LICENSEE
accepts, subject to the terms and conditions of this
Agreement :
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3.01.1 A non-exclusive license under the
Licensed Mouse Patent Rights to use or have used MICE
in the Licensed Mouse Patent Field of Use in the Licensed
Mouse Patent Territory . Under a Sponsored Research Agreement
between OHSU and LICENSEE , OHSU shall provide
MICE in order for OHSU investigators to conduct
research under the scope of work with payment for the MICE
upkeep to be covered under the Sponsored Research Agreement.
LICENSEE has the option to request additional MICE to
use outside of OHSU . If LICENSEE requests additional
MICE , OHSU shall provide LICENSEE with one
breeding pair of MICE consisting of one homozygous male and
two homozygous females; if the pair of MICE does not
successfully breed (an "Unsuccessful Breeding Pair") OHSU
shall provide LICENSEE with a replacement breeding pair of
MICE .
3.01.2 co-exclusive license under the Licensed Screening
Patent Rights in the Licensed Screening Patent Territory
to use or have used the Licensed Screening Patent Rights in
the Licensed Screening Patent Field of Use .
3.01.2.1 LICENSEE is not
granted the right to provide screening services on a
fee-for-service basis to third parties, unless the screening is
covered under Section 4.01.
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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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3.01.2.2 Each co-licensee will have rights and restrictions
related to the Licensed Screening Patent Rights consistent
with the terms of this Agreement , including all Sections of
3.01.2.1, 4.01, 4.01.1-4.01.3.
3.01.3 An assignment of all of OHSU ’s claim of
right, title, and interest to the Therapeutic Patent
(including the regular utility application) by OHSU to
LICENSEE .
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3.02
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This Agreement confers no license or
rights by implication, estoppel, or otherwise under any patent
applications or patents of OHSU other than the Patent
Rights regardless of whether such patents are dominant or
subordinate to the patent rights granted.
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3.03
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OHSU retains the right to use the
Patent Rights for educational and research purposes, and permit
other academic and nonprofit organizations to use the Licensed
Mouse Patent Rights and Licensed Screening Patent Rights
for educational and non-commercial research purposes. In addition,
for the Licensed Mouse Patent Rights , and Licensed
Screening Patent Rights , a license is reserved on behalf of
the Government , subject to Section 5.01 below.
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3.04
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LICENSEE agrees with the
following:
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3.04.1 LICENSEE shall not initiate
breeding activities with MICE , other than between the
pair(s) provided and direct descendants thereof, without advance
written permission of OHSU .
3.04.2 LICENSEE shall use MICE only for animal
(non-food) experimentation, and shall handle MICE humanely
and in compliance with all applicable laws and regulations,
including animal welfare regulations.
3.04.3 LICENSEE shall not transfer MICE to any
other party, and will limit access to MICE to its
researchers who are bound by the obligations of this
Agreement .
3.04.4 LICENSEE assumes all responsibility for the safe
use and handling of MICE , and will defend, indemnify and
hold harmless OHSU , and its Directors, Trustees, employees,
officers, fellows, students and agents against any and all claims
of LICENSEE and third parties arising from its acceptance,
use, storage, handling, or disposal of MICE .
3.04.5 This Agreement is a bailment of MICE from
OHSU to LICENSEE , and ownership of MICE is
not transferred to LICENSEE .
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4.
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SUBLICENSING
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4.01
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Upon written approval by OHSU , which
approval will not be unreasonably withheld, LICENSEE may
enter into sublicensing agreements for the Licensed Screening
Patent Rights for the sole purpose of collaborating with the
sublicensee in the discovery and
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development of Licensed Products or
Screening Products in the Licensed Screening Patent Field
of Use , provided that
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4.01.1 each sublicense has a grant that is
consistent with the terms of Paragraph 3.01.2 herein;
4.01.2 the earned royalty rates on Net Sales in each
sublicense shall be the same or greater than as set forth in
Paragraph 6.03 herein; and
4.01.3 LICENSEE shall be responsible for payment of
earned royalties to OHSU on Net Sales by sublicensees
(i) as if such Net Sales were made by LICENSEE
directly, and (ii) pursuant to the terms and conditions of
this Agreement .
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4.02
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LICENSEE agrees that any sublicenses
granted by it shall provide that the obligations to OHSU of
Paragraphs 5.01-5.02, 7.01, 9.01, 9.03, 12.05, and 13.05-13.07 of
this Agreement shall be binding upon the sublicensee as if
it were a party to this Agreement . LICENSEE further
agrees to attach copies of these Paragraphs to all sublicense
agreements.
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4.03
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Any sublicenses granted by LICENSEE shall
provide for the termination of the sublicense, or the conversion to
a license directly between such sublicensees and OHSU , at
the option of the sublicensee, upon termination of this
Agreement under Article 13. Such conversion is subject
to OHSU approval and contingent upon acceptance by the
sublicensee of the remaining provisions of this Agreement
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4.04
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LICENSEE agrees to forward to OHSU
a copy of each fully executed sublicense agreement postmarked
within sixty (60) days of the execution of such agreement.
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5.
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RESERVED GOVERNMENT RIGHTS
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5.01
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OHSU reserves on behalf of the
Government an irrevocable, nonexclusive, nontransferable,
royalty-free license for the practice of all inventions licensed
under the Licensed Mouse Patent Rights and Licensed
Screening Patent Rights throughout the world by or on behalf of
the Government and on behalf of any foreign government or
international organization pursuant to any existing or future
treaty or agreement to which the Government is a
signatory.
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5.02
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LICENSEE agrees that products used or
sold in the United States embodying Licensed Products or
Screening Products should be manufactured substantially in
the United States, unless a written waiver is obtained in advance
from the Government .
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6.
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ROYALTIES AND REIMBURSEMENT
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6.01
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LICENSEE agrees to pay to OHSU an
upfront, non-creditable, non-refundable license royalty fee of
Sixty-Five Thousand U. S. Dollars (US $65,000) within thirty
(30) days from the Effective Date .
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6.02
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LICENSEE shall pay to OHSU an
additional license royalty in the amount of Twenty Thousand U.S.
Dollars (US $20,000) upon receipt of pair of MICE under the
option described in Paragraph 3.01.1. LICENSEE shall
pay to OHSU a further license royalty in the amount of
Twenty Thousand U.S. Dollars (US $20,000) per pair upon receipt of
any additional pair of MICE . LICENSEE shall pay all
transportation costs for shipment of any MICE from
OHSU to LICENSEE . However, no additional royalties
shall be due for a pair of MICE received as replacement for
an Unsuccessful Breeding Pair under Paragraph 3.01.1, and such
a replacement pair of MICE shall be shipped to
LICENSEE at OHSU ’s expense.
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6.03
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LICENSEE agrees to pay OHSU an
earned royalty of [***] percent ([***]%) percent on Net
Sales on Licensed Products or Screening
Products.
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6.03.1 On sales of Licensed Products or
Screening Products by LICENSEE to sublicensees or
affiliated parties or on sales made in other than an
arm’s-length transaction, the value of the Net Sales
attributed under this Article 6.03 to such a transaction shall
be that which would have been received in an arm’s-length
transaction, based on sales of like quantity and quality products
on or about the time of such transaction.
6.03.2 No multiple royalties shall be payable to OHSU
because any Licensed Products or Screening Products
are covered by more than one of the Patent Rights in this
Agreement .
6.03.3 The term of the royalties will be:
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6.03.3.1
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For Licensed Products , royalties shall be
paid based on the existence of a Valid Claim in the country
of intended use.
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6.03.3.2
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For Screening Products , royalties will be
due until the last of the following expire:
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6.03.3.2.1
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if OHSU is the assignee on some or all of
the inventorship rights on the Screening Product patent
under which the royalties are due, royalties shall be paid based on
the existence of a Valid Claim in the country of intended
use.
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6.03.3.2.2
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If OHSU is not the assignee on some or all
of the inventorship rights on the Screening Product patent
under which the royalties are due, royalties are due on the
Screening Product in all countries in which the Screening
Product patent is maintained until the last to expire of the a)
Licensed Mouse Patent Rights or b) Licensed Screening
Patent Rights .
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6.03.4 Royalties will be paid pursuant to
Article 8.02 below.
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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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6.04
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LICENSEE agrees to pay OHSU ,
within [***] ([***]) days of OHSU ’s submission of a
statement and request for payment, an amount equivalent to [***]
([***]%) of expenses previously incurred by OHSU in the
preparation, filing, prosecution, and maintenance of Licensed
Screening Patent Rights. LICENSEE further agrees to pay to
OHSU , within [***] ([***]) days of OHSU ’s
submission of a statement and request for payment to
LICENSEE , a royalty amount equivalent to [***] percent
([***]%) of all such ongoing patent expenses incurred for
Licensed Screening Patent Rights .
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6.04.1 LICENSEE may elect to surrender its
rights in any country of the Licensed Screening Patent
Territory under any Licensed Screening Patent Rights
upon [***] ([***]) days’ written notice to OHSU and
owe no payment obligation under this paragraph for s
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