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.
Oregon Health & Science
University
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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
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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 unde
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