Document:

exv10w21

 

EXHIBIT
10.21

EXECUTION COPY

RESEARCH AGREEMENT #2

This Research Agreement (this “Agreement”) is entered into between Orexigen Therapeutics,
Inc. with offices at 12481 High Bluff Drive, San Diego, CA 92130, hereinafter referred to as
“SPONSOR”, and the Oregon Health & Science University, a non-profit, public corporation of the
state of Oregon, located at 3181 SW Sam Jackson Park Road, Portland, Oregon 97239, hereinafter
referred to as “UNIVERSITY”.

WITNESSETH:

WHEREAS, SPONSOR entered into a Research Agreement with UNIVERSITY effective July 14, 2003 to have
UNIVERSITY perform the research services set forth in the scope of work (attached hereto as
Attachment A) (“Research Agreement #1”); and

WHEREAS, it is anticipated that the term of Research Agreement #1 will expire prior to completion
of the research set forth therein and the parties wish to continue the relationship to complete the
research services requested under Research Agreement #1;

WHEREAS, SPONSOR also desires to have UNIVERSITY perform additional research services which are set
forth in the scope of work (attached hereto as Attachment B);

WHEREAS, the performance of such research is consistent, compatible and beneficial to the academic
role and mission of UNIVERSITY as an institution of higher education, and, in consideration of the
mutual promises and covenants contained herein, the parties hereto agree to incorporate the terms
of Research Agreement #1 into this Agreement so that the research services set forth in
Attachment A and Attachment B may be performed pursuant to this Agreement on the
terms and conditions as follows:

ARTICLE I — SCOPE OF WORK 

UNIVERSITY agrees to use all reasonable best efforts to perform for SPONSOR the research activities
described in Attachment A and Attachment B, hereinafter, collectively, the “SCOPE
OF WORK”, under the direction and supervision of Michael Cowley, PhD, hereinafter “PRINCIPAL
INVESTIGATOR” or “PI”. UNIVERSITY agrees that during the term of this agreement the PI shall not
conduct, direct, nor assist in other corporate-funded research or services directed toward
screening, analysis, or development of therapeutic agents for the treatment of obesity.

ARTICLE II — TERM

This Agreement shall become effective as of May 1, 2006 (the “Effective Date”), and shall
be shall be effective for a period of Two and One-half (2 1/2) years unless mutually agreed upon in
writing between the parties.

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ARTICLE III — COMPENSATION

SPONSOR agrees to reimburse UNIVERSITY for services performed under this Agreement in accordance
with the budget itemized in Attachment C, with payments to be made as follows: on August 5,
2006, $273,155; on May 1, 2007, $46,892; on July 1, 2007, $235,896; and on May 1, 2008, $291,569;
provided, however, that each such payment shall be subject to receipt of the written reports from
the PI as described in the SCOPE OF WORK. Checks to UNIVERSITY shall be made payable to OREGON
HEALTH SCIENCES UNIVERSITY and mailed to:

OREGON HEALTH & SCIENCE UNIVERSITY

Sponsored Projects Administration

2525 SW 1st Avenue, Suite 220

Portland, OR 97201

Tax ID No.: 93-1176109

The UNIVERSITY represents to the best of its knowledge that no funds, equipment, personnel or
facilities will be used in the completion of the SCOPE OF WORK, which are encumbered by any
commercial third party entity in such a way that such third party can claim any intellectual
property rights in inventions or discoveries arising from the research activities under this
Agreement.

ARTICLE IV — REPORTING REQUIREMENTS 

UNIVERSITY will provide reports on the progress of the research as outlined or required in the
SCOPE OF WORK. The PI will prepare up to two (2) oral and two (2) written reports per year. The
written report shall summarize all work conducted during the previous period and shall include
copies of supporting data. Orexigen, at its expense, shall have the right to review the supporting
data and utilize such data for the purpose of regulatory submission.

ARTICLE V — CONFIDENTIALITY and PUBLICATION 

UNIVERSITY and PRINCIPAL INVESTIGATOR agree to keep confidential any SPONSOR confidential and
proprietary information supplied to it in writing (or reduced to writing within 30 days of
non-written disclosure) by SPONSOR and marked CONFIDENTIAL during the course of research performed
by UNIVERSITY (“Confidential Information”), and further agrees not to use Confidential
Information for the benefit of any third party. SPONSOR’s Confidential Information shall also
include all reports, data and other information generated pursuant to the SCOPE OF WORK. This
obligation extends for a period of five (5) years after the term of this Agreement. Such
Confidential Information will not be included in any patent application or published material
without prior written approval by SPONSOR.

The obligations of this Section shall not apply to:

	(1)	 	information which is or becomes known publicly through no fault of the UNIVERSITY or
PRINCIPAL INVESTIGATOR;
	 
	(2)	 	information learned by UNIVERSITY or PRINCIPAL INVESTIGATOR through a third party entitled to
disclose it;

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	(3)	 	information developed by UNIVERSITY or PRINCIPAL INVESTIGATOR independently of information
obtained from SPONSOR as shown by written records;

	(4)	 	information already known to UNIVERSITY or PRINCIPAL INVESTIGATOR before SPONSOR’s disclosure
as shown by witnessed prior written records; or

	(5)	 	information required to be disclosed by law, including the Oregon Public Records Law, to
comply with government regulations, subpoenas or court orders provided SPONSOR receives
adequate notice of such demand and provided UNIVERSITY or PRINCIPAL INVESTIGATOR makes any
such disclosure under an order protecting the confidential nature of proprietary information.

UNIVERSITY agrees to provide any proposed publication to SPONSOR sixty (60) days prior to
submission, for confidential review for the inclusion of SPONSOR Confidential Information, and to
determine whether patentable inventions or discoveries are disclosed therein. SPONSOR has the
right to edit or remove SPONSOR Confidential Information, prior to submission for publication.
Should the documents contain any patentable information, at SPONSOR’s request, UNIVERSITY shall
withhold submission and/or publication for an additional sixty (60) days to allow U.S. patent
filings. In addition, in the event that the document includes data, information or material
conceived or generated by SPONSOR’s scientists, and professional standards for authorship would be
consistent with including SPONSOR’s scientists as co-authors of the document, the names of
SPONSOR’s scientists will be included as co-authors.

ARTICLE VI — EQUIPMENT

All equipment purchased under the terms of this agreement becomes the property of UNIVERSITY unless
otherwise specified herein.

ARTICLE VII — INDEMNIFICATION 

Each party hereto agrees to be responsible and assume liability for its own wrongful or negligent
acts or omissions, or those of its officers, agents or employees to the full extent required by
law, including the Oregon Tort Claims Act, ORS Sections 30.260 through 30.300.

ARTICLE VIII — COMPLIANCE WITH LAWS 

UNIVERSITY and PRINCIPAL INVESTIGATOR agree to comply with all applicable federal, state and local
laws, codes, regulations, rules and orders.

ARTICLE IX — ASSIGNMENT 

Neither party shall assign or transfer any interest in this Agreement, nor assign any claims for
money due or to become due during this Agreement, without the prior written approval of the other
party, except that SPONSOR may assign this Agreement to an affiliate or to a successor in
connection with the merger, consolidation, or sale of all or substantially all of its assets or
that portion of its business to which this Agreement relates.

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ARTICLE X — PATENTS AND INVENTIONS 

	(1)	 	UNIVERSITY Inventions. Title to any new and patentable discovery or invention and all
related intellectual property rights (each, an “Invention”) conceived, made or reduced
to practice solely by UNIVERSITY or PRINCIPAL INVESTIGATOR in the performance of the research
shall vest exclusively in UNIVERSITY; provided, however, that UNIVERSITY shall
not claim any ownership of intellectual property which relates to the SCOPE OF WORK, nor claim
title to any Invention relating to an indication, use or dosage for the drug(s) (and its class
of analogs) under SCOPE OF WORK.

	(2)	 	SPONSOR Inventions. Title to any Invention and all related intellectual property
rights conceived, made or reduced to practice solely by SPONSOR in the performance of the
research shall vest exclusively in SPONSOR.

	(3)	 	Joint Inventions. Each Invention conceived, made or reduced to practice jointly by
UNIVERSITY (and/or PRINCIPAL INVESTIGATOR) and SPONSOR in the performance of the research
shall be jointly owned by UNIVERSITY and SPONSOR; provided, however, that
title to any Invention relating to an indication, use or dosage for the drug(s) (and its class
of analogs) under the SCOPE OF WORK or relates to the SCOPE OF WORK shall vest exclusively in
SPONSOR.

	(4)	 	Reporting: Patent Application, Filing and Expenses. UNIVERSITY will promptly report
to SPONSOR in writing any Invention conceived or discovered by it or any UNIVERSITY personnel
conducting the research under this Agreement. UNIVERSITY shall be responsible for preparing,
filing, prosecuting and maintaining patent applications for UNIVERSITY Inventions. SPONSOR
shall be responsible for preparing, filing, prosecuting and maintaining patent applications
for joint Inventions. Prior to filing a patent application or filing or responding to any
outstanding communication in connection with a patent application directed to a UNIVERSITY
Invention or joint Invention, the filing party will provide the other party with thirty (30)
days notice to review and provide comment thereon, unless such thirty (30) days notice is
impossible due to a governmentally-imposed deadline, in which case the filing party shall
provide the other party with the maximum time reasonably possible to review and provide
comments.

	(5)	 	No Conflict. UNIVERSITY will ensure that the PRINCIPAL INVESTIGATOR and all other
study personnel are bound or shall have agreed (i) to comply with the terms of this Agreement,
(ii) to assign all their rights and interest in any Invention made by them to UNIVERSITY, and
(iii) not to enter into agreements with third parties which would impair their ability to
perform this Agreement.

	(6)	 	SPONSOR Property. Nothing in this Agreement shall be interpreted as giving UNIVERSITY
any rights under any intellectual property rights now, or hereafter, owned by or licensed to
SPONSOR by a third party.

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ARTICLE XI — LICENSE

With respect to any Invention in which UNIVERSITY has an interest under Article X(1) and Article
X(3), UNIVERSITY hereby grants SPONSOR an exclusive option (hereafter the “Option”) to
elect to negotiate an exclusive worldwide license for such Invention. This Option extends for
ninety (90) days from disclosure of the Invention to SPONSOR.

The parties shall have one hundred fifty (150) days from the date SPONSOR elects to negotiate for
an exclusive license to conclude a license agreement. Such period may be extended by mutual
consent of the parties, or may be terminated at any time by SPONSOR by written notice. SPONSOR and
UNIVERSITY agree to negotiate diligently and in good faith to arrive at a license that is mutually
beneficial to both parties. SPONSOR shall pay all patent costs for the Inventions during the one
hundred fifty (150) day negotiation period, or any extension thereof. If at the end of such one
hundred fifty (150) day period or any extension thereof, the parties are unable to agree upon
licensing terms, SPONSOR shall have no further obligation to pay patent costs for the Invention(s)
for which negotiations have terminated. If SPONSOR terminates the negotiation in writing prior to
the end of the one hundred fifty (150) day negotiation period, SPONSOR shall have no further
obligation to pay patent costs incurred after the termination date. In the event SPONSOR does not
exercise its Option rights or SPONSOR and UNIVERSITY are unable in good faith to agree to mutually
acceptable licensing terms, UNIVERSITY has the right to license its rights to a third party;
however, nothing herein shall permit UNIVERSITY to license or grant any of SPONSOR’s intellectual
property rights to any third party, provided further, that before accepting an offer from a third
party on terms more favorable than those offered to SPONSOR to acquire any rights in Inventions to
which UNIVERSITY has an interest, UNIVERSITY will inform SPONSOR of such offer and shall allow
SPONSOR a period of thirty (30) days thereafter in which to elect whether to acquire the right to
the Invention under such terms as are offered to UNIVERSITY by the third party.

ARTICLE XII — PUBLICATION BY SPONSOR 

SPONSOR will not include the name of UNIVERSITY in any advertising, sales, promotion, or other
publicity matter without prior written approval of UNIVERSITY. UNIVERSITY will not include the
name of SPONSOR in any advertising, sales, promotion, or other publicity matter without prior
written approval of SPONSOR.

ARTICLE XIII — TERMINATION

Either party may terminate this Agreement at any time if:

	(1)	 	The other party materially breaches the terms of this Agreement, provided that the
non-breaching party shall have given the breaching party written notice of such breach and the
breaching party shall have failed to cure the same within thirty (30) days after receipt of
such notice;
	 
	(2)	 	The loss or departure of PRINCIPAL INVESTIGATOR, and a mutually acceptable replacement cannot
be found;

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	(3)	 	Performance of any part of this Agreement by a party is prevented or delayed by reason of
Force Majeure and cannot be overcome by reasonable diligence to the satisfaction of either
party;
	 
	(4)	 	The other party ceases, discontinues or indefinitely suspends its business activities related
to the services to be provided under this Agreement, or the other party voluntarily or
involuntarily files for bankruptcy; or
	 
	(5)	 	The party has given ninety (90) days written notice to the other party.

The party requesting termination will provide the other party with written notice specifying both
the reason and the effective date of termination. Upon the giving of such notice of termination by
either party, the UNIVERSITY will use its reasonable best efforts to limit or terminate any
outstanding commitments.

Upon termination, UNIVERSITY shall deliver to SPONSOR in the state they exist as of the date of
termination of all work product, and Confidential Information belonging to SPONSOR. SPONSOR shall
within thirty (30) days after termination pay UNIVERSITY all payments due as of the effective date
of termination.

The provisions of Articles V, VII, X, XI, XII, and XIV shall survive termination of this Agreement.

ARTICLE XIV – NOTICES

All notices or communications given hereunder shall be in writing and shall be delivered by hand,
or by overnight courier, by facsimile with confirmation by mail, with all delivery charges prepaid
and addressed to the parties as follows:

	 	 	 
	TO SPONSOR:

	 	Orexigen Therapeutics, Inc
	 

	 	12481 High Bluff Drive
	 

	 	San Diego, CA 92130
	 

	 	Phone: (858) 480-2420
	 

	 	Fax: (848) 480-2401
	TO UNIVERSITY:

	 	Director, Technology & Research Collaborations
	 

	 	Oregon Health & Science University, AD120
	 

	 	2525 SW First Avenue, Suite 120
	 

	 	Portland, OR 97201-4753
	 

	 	Telephone: (503) 494-8200
	 

	 	Fax: (503) 494-4729
	 
	 	 
	 

	 	with copy to
	 
	 	 
	TO PRINCIPAL INVESTIGATOR:

	 	Michael Cowley, Ph.D.

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ARTICLE XV — CHANGES AND AMENDMENTS 

THIS AGREEMENT CONSTITUTES THE ENTIRE AGREEMENT BETWEEN THE PARTIES. THERE ARE NO UNDERSTANDINGS,
AGREEMENTS, OR REPRESENTATIONS, ORAL OR WRITTEN, NOT SPECIFIED HEREIN REGARDING THIS AGREEMENT. NO
AMENDMENT, CONSENT OR WAIVER OF TERMS OF THIS AGREEMENT SHALL BIND EITHER PARTY UNLESS IN WRITING
AND SIGNED BY ALL PARTIES. ANY SUCH AMENDMENT, CONSENT, OR WAIVER SHALL BE EFFECTIVE ONLY IN THE
SPECIFIC INSTANCE AND FOR THE SPECIFIC PURPOSE GIVEN. SPONSOR, BY THE SIGNATURE BELOW OF ITS
AUTHORIZED REPRESENTATIVE, ACKNOWLEDGES HAVING READ AND UNDERSTOOD THE AGREEMENT AND SPONSOR AGREES
TO BE BOUND BY ITS TERMS AND CONDITIONS.

ARTICLE
XVI — RESEARCH AGREEMENT #1 SUPERSEDED

On the Effective Date, the terms of Research Agreement #1, including any amendment or addendum
thereto, is hereby superseded by this Agreement and such Research Agreement #1 will have no further
force and effect.

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In Witness Whereof, the parties hereto have caused this Agreement to be executed as of the date set
forth herein by their duly authorized representatives.

	 	 	 	 	 	 	 
	OREGON HEALTH & 

SCIENCE UNIVERSITY

	 	 	 	SPONSOR	 	 
	 
	 	 	 	 	 	 
	[illegible]            8/04/2006

For Arundeep Pradhan           Date

	 	 	 	/s/ Gary D. Tollefson 8/06/2006
 

Gary Tollefson, MD, PhD       Date
	 	 
	Director

	 	 	 	CEO	 	 
	Technology and Research Collaborations

	 	 	 	Orexigen Therapeutics, Inc	 	 
	 
	 	 	 	 	 	 
	Acknowledged By Principal Investigator:
	 	 	 	 	 	 
	 
	 	 	 	 	 	 
	[illegible]            8/04/2006
	 	 	 	 	 	 

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Attachment A

Scope of work

Lay summary of Orexigen Therapeutics Inc., proposed sponsored research in the Cowley Lab.

Recent work in the laboratory operated and supervised by Michael Cowley, Ph.D. (the “Cowley Lab”),
and other laboratories, has demonstrated that a neuronal circuit within the hypothalamus functions
a common pathway for many signals of energy state. Aspects of this work also demonstrated that
this hypothalamic circuitry was the target through which fenfluramine acted to cause weight loss,
and that this pathway is necessary for fenfluramine induced weight loss. Although fenfluramine is
no longer used as a weight control agent, other safer, drugs act in a similar manner to
fenfluramine. Clinical data, and detailed study of the neuronal circuitry, has suggested several
drug combinations that may act synergistically to active the hypothalamic circuits that control
body weight. In particular, it is hypothesized that blocking auto-inhibition of these circuits
will allow them to remain active, and responsive to weight control drugs. The work outlined in
this proposal will assess the effects of 3 different classes of drug combination on the activity of
hypothalamic neurons, and on body weight in mice.

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Attachment B

Scope of work

The research that SPONSOR sponsors at OHSU is to provide support for SPONSOR’s intellectual
property. The scope of clinical trials being undertaken at SPONSOR has changed and now includes
additional drugs. Thus it is necessary to change the scope of work being undertaken at the
laboratory operated and supervised by Michael Cowley, Ph.D., the (“Cowley Lab”) at ONPRC/OHSU.

“Orexigen drug combinations” refers to, among others:

Opioid receptor antagonists

Serotonin reuptake inhibitors

Dopamine reuptake inhibitors

Norepinephrine reuptake inhibitors

Anticonvulsants (Zonisamide, Topiramate)

Antipsychotic including, but not limited to, olanzapine, respiradone and

ziprasidone

Thiazolidinedione-type diabetes drugs

Cannabinoid receptor antagonists

UNIVERSITY agrees to study and/or perform the following activities in accordance with the terms of
this Agreement:

	 	•	 	Confirm Bupropion/Zonisamide synergy in rat.
	 
	 	•	 	Effects of Orexigen drug combinations on electrophysiological properties of POMC
neurons.
	 
	 	•	 	Effects of Orexigen drug combinations on “Compound A”, “Compound B”, “Compound C” or
“Compound D” induced weight gain.
	 
	 	•	 	Effects of Orexigen drug combinations on “Compound A”, “Compound B” or
	 
	 	 	 	“Compound C” induced electrophysiological changes in POMC neurons.
	 
	 	•	 	Mechanism of Zonisamide induced weight changes

	 	o	 	What parts of the rodent brain does Zonisamide activate?
	 
	 	o	 	Does Zonisamide cause a greater weight loss to fasted rats?
	 
	 	o	 	Does Zonisamide effect lipogenisis?

	 	•	 	Do Orexigen drug combinations cause changes in insulin secretion/sensitivity?
	 
	 	•	 	Do Orexigen drug combinations cause changes in Angiotensin II, endothelin, big
endothelin, cytokine markers such as p-selectin, or C-reactive protein?
	 
	 	•	 	Measure secretion of melanocortin peptides from hypothalamic pieces in response to Z, B,
O, M, Z+B, N, N+B, N+B+Z.
	 
	 	•	 	Develop a model of metabolic disease, for example the spontaneously hypertensive rat,
and determine if the Orexigen combinations exert beneficial effects in this model.

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Attachment C

Budget

	 	 	 
	NAME of Project

	 	Electrophysiological Testing of Drug Combinations
	COWLEY, Michael
	 	 
	Orexigen Contract
	 	 

Detailed Budget calcs

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Salary	 	FB	 	Total	 	 	 	 	 	 	 	 
	Cowley
	 	 	0.2	 	 	 	92,608	 	 	 	 	 	 	 	18,522	 	 	 	5,742	 	 	 	24,264	 	 	 	 	 	 	 	 	 
	Wallingford
	 	 	1.0	 	 	 	41,200	 	 	 	 	 	 	 	41,200	 	 	 	14,420	 	 	 	55,620	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	59,722	 	 	 	20,162	 	 	 	79,884	 	 	 	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Admin
	 	Yr 1	 	Yr 2	 	 	 	 	 	Yr 3	 	 	 	 	 	 	 	 	 	Total DC	 	 	 	 
	Personnel
	 	 	79,884	 	 	 	82,281	 	 	 	 	 	 	 	84,749	 	 	 	 	 	 	 	 	 	 	 	246,913	 	 	 	 	 
	Consultant
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	—	 	 	 	 	 
	Equip
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	—	 	 	 	 	 
	Supplies
	 	 	52,906	 	 	 	54,493	 	 	 	 	 	 	 	56,128	 	 	 	 	 	 	 	 	 	 	 	163,527	 	 	 	 	 
	Travel
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	—	 	 	 	 	 
	Other
	 	 	34,790	 	 	 	35,834	 	 	 	 	 	 	 	36,909	 	 	 	 	 	 	 	 	 	 	 	107,532	 	 	 	 	 
	Sub DC
	 	 	—	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	—	 	 	 	 	 
	Sub F&A
	 	 	—	 	 	 	—	 	 	 	 	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	 	 
	 
	 	 	167,580	 	 	 	172,602	 	 	 	 	 	 	 	177,786	 	 	 	—	 	 	 	—	 	 	 	517,973	 	 	 	 	 

Face Page & Check List Page Calcs Worksheet

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	5/06 - 4/07	 	 	5/07 - 6/07	 	 	7/07 - 4/08	 	 	5/08 - 4/09	 	 	5/09 - 3/10	 	 	4/10 - 3/11	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	3mos	 	 	10 mos	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Yr 1	 	 	Yr 2	 	 	 	 	 	 	 Yr 3	 	 	Yr 4	 	 	Yr 5	 	 	Total All	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Years	 	 	 	 	 
	Total DC
	 	 	167,580	 	 	 	28,768	 	 	 	143,840	 	 	 	177,786	 	 	 	—	 	 	 	—	 	 	 	517,973	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Less Equip
(Exclusion)
	 	 	—	 	 	 	—	 	 	 	 	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	 	 

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	 	 	5/06 - 4/07	 	 	5/07 - 6/07	 	 	7/07 - 4/08	 	 	5/08 - 4/09	 	 	5/09 - 3/10	 	 	4/10 - 3/11	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	3mos	 	 	10 mos	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Yr 1	 	 	Yr 2	 	 	 	 	 	 	 Yr 3	 	 	Yr 4	 	 	Yr 5	 	 	Total All	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	Years	 	 	 	 	 
	Less OHSU base
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	—	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	ONPRC Base DC
	 	 	167,580	 	 	 	28,768	 	 	 	143,840	 	 	 	177,786	 	 	 	—	 	 	 	—	 	 	 	517,973	 	 	 	 	 
	F&A rate (ONPRC)
	 	 	0.63	 	 	 	0.63	 	 	 	0.64	 	 	 	0.64	 	 	 	—	 	 	 	—	 	 	 	—	 	 	 	 	 
	F&A (ONPRC)
	 	 	105,575	 	 	 	18,124	 	 	 	92,056	 	 	 	113,783	 	 	 	—	 	 	 	—	 	 	 	329,538	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Total F&A
	 	 	105,575	 	 	 	18,124	 	 	 	92,056	 	 	 	113,783	 	 	 	—	 	 	 	—	 	 	 	329,538	 	 	 	 	 
	Total Proj Costs
	 	 	273,155	 	 	 	46,892	 	 	 	235,896	 	 	 	291,569	 	 	 	—	 	 	 	—	 	 	 	847,511	 	 	Total

 Proj 

Costsexv10w22

 

EXHIBIT 10.22

MASTER AGREEMENT FOR PHARMACEUTICAL DEVELOPMENT SERVICES

 

	 	 	 	 	 	 	 	 	 
	1.

	 	Parties:
	 	 	 	Patheon Pharmaceuticals
Inc. (“Patheon”)
	 	Orexigen Therapeutics Inc. (“Client”)
	 

	 	 	 	 	 	2110 East Galbraith Road
	 	28202 Cabot Road, Suite 200
	 

	 	 	 	 	 	Cincinnati, Ohio 45237
	 	Laguna Neguel, CA 92677

	 	 	 	 	 	 	 
	2.

	 	Projects:
	 	 	 	Patheon may agree from time to time to perform the pharmaceutical development services for the
Client described in a Project Proposal duly completed and executed by Patheon and the Client in
the form attached hereto as Schedule B.
	 
	 	 	 	 	 	 
	3.

	 	Contract:
	 	 	 	Upon execution of a Project Proposal by Patheon and the Client, this agreement together with the
Project Proposal (including the Project Scope and Budget Summary) shall be a contract binding on
the parties (“Contract”).
	 
	 	 	 	 	 	 
	4.

	 	Legal Terms:
	 	 	 	The Terms and Conditions attached hereto as Schedule A shall apply to each Project.
	 
	 	 	 	 	 	 
	5.

	 	Date of
Confidentiality
Agreement:
	 	 	 	August 24, 2005
	 
	 	 	 	 	 	 
	6.

	 	Date of
Patheon
PartnerTM
External User
Account/Account
Form
	 	 	 	•, 200•
[If applicable]
	 
	 	 	 	 	 	 
	7.

	 	Date
	 	 	 	February 16, 2007

	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Patheon Pharmaceuticals Inc.	 	 	 	Orexigen Therapeutics Inc.
	 
	By:

	 	/s/ Edward W. Huber
	 	 	 	By:
	 	/s/ Anthony McKinney	 	 	 	 	 	 
	 

	 	 
	 	 	 	 	 	 	 	 	 	 	 	 
	Name:

	 	Edward W. Huber
	 	 	 	Name:
	 	Anthony McKinney	 	 	 	 	 	 
	Title:

	 	Acting Group Director, PDS
	 	 	 	Title:	 	Chief Operating Officer	 	 	 	 	 	 

CONFIDENTIAL

 

 

Schedule A:

STANDARD TERMS AND CONDITIONS

FOR

PHARMACEUTICAL DEVELOPMENT SERVICES

(Certain capitalized terms used herein but not defined are defined in the Project Proposal)

	1.	 	Services:

	 	(a)	 	Patheon agrees to perform the pharmaceutical development services described in the
Project Scope (“Services”).
	 
	 	(b)	 	Parties must agree on changes, deletions or additions to the Services (“Changes”).
	 
	 	(c)	 	Minor Changes shall be confirmed by electronic mail, facsimile or other written
document. Significant Changes (such as a request by the Client to change the Project
Scope) shall be confirmed by a Change of Scope Agreement.

	2.	 	Payment and Deposit:

	 	A.	 	Payment

	 	(a)	 	Client shall pay Patheon for the Services as outlined in this Contract and for
any Changes which shall be invoiced separately at Patheon’s then prevailing hourly
rates.
	 
	 	(b)	 	If Client causes any delay to Patheon’s provision of Services for reason
within its control (such as a delay in responding to a Patheon inquiry or a delay in
the delivery of the active pharmaceutical ingredient (“API”)), then Patheon shall
be entitled to charge the Client for any additional reasonable costs incurred in the
provision of the Services as a result of the delay.
	 
	 	(c)	 	Patheon invoices may be issued upon completion of each milestone set out in
the Budget Summary and shall be due and payable within 30 days of the date of such
invoice. If Client anticipates not being able to meet the net 30 day terms, then Client
may request that Patheon forward each invoice to the facsimile number and/or email
address stipulated by the Client from time to time to ensure that it has the full 30
days to process payment.

	 	B.	 	Deposit (if Applicable as per the Budget Summary)

	 	(a)	 	Prior to the commencement of the Services, Client shall deliver to Patheon the
deposit (“Deposit”) set out in the Budget Summary.
	 
	 	(b)	 	Deposit shall be held by Patheon until the Services are fully completed or
until this Contract expires or is terminated in accordance with Section 4.
	 
	 	(c)	 	Deposit shall be credited towards the final invoice for the Services and any
remaining balance shall be returned to the Client.
	 
	 	(d)	 	Patheon may apply all or a portion of the Deposit against any accounts overdue
in excess of 60 days from the date of the invoice.
	 
	 	(e)	 	Patheon may, at its option, suspend all Services until such time as any
outstanding invoices have been paid in full and the original amount of the Deposit has
been replenished.

	3.	 	Supply of API and Materials:

	 	(a)	 	Client shall, at its expense, supply Patheon with sufficient quantities of the API for
Patheon’s use in performing the Services.
	 
	 	(b)	 	The costs of all third party suppliers’ fees and the purchase of project specific items
(such as raw materials, excipients, packaging, special equipment, tooling, change
parts, laboratory columns and reagents, reference standards including those under the
applicable United States Pharmacopoeia, the National Formulary, the British Pharmacopoeia,
the European Pharmacopoeia or the Japanese Pharmacopoeia) necessary for Patheon to perform
the Services shall be purchased by Patheon and charged to Client at Patheon’s cost plus an additional 15% as a handling charge. Patheon
shall obtain Client’s prior written approval for all such expenses in excess of $10,000.
	 
	 	(c)	 	If applicable, Patheon and the Client will cooperate and provide such assistance to each other as
may be reasonably necessary to permit the import of the API and other materials into the
country where the Services will be performed.

	4.	 	Termination:

	 	(a)	 	Either party may terminate this Contract if the other party is in material breach of any
provisions of this Contract and the other party fails to remedy such breach within 30 days
of the date of notice of such breach by the non-breaching party.
	 
	 	(b)	 	Client may terminate this Contract immediately for any business reason.
	 
	 	(c)	 	Any re-scheduling of any part of the Services beyond 120 days requested by Client
shall, at Patheon’s option, be deemed to be a termination of the Contract.
	 
	 	(d)	 	Upon completion or expiry of the Contract or if the Client terminates the Contract for
any business reason or if Patheon terminates the Contract because of: (i) Client’s failure
to cure any default within the 30 day notice period; or (ii) Client rescheduling any part
of the Services beyond the 120 days, then Client shall pay to Patheon:

	 	•	 	any fees and expenses due to Patheon for the Services rendered up to the date of
completion, expiry or termination;
	 
	 	•	 	all actual costs incurred by Patheon to complete activities associated with the
completion, expiry or termination and close of the Services rendered up to the date of
completion, expiry or termination including, without limitation disposal fees that may
be payable in respect of any materials and supplies owned by the Client to be disposed
of by Patheon; and
	 
	 	•	 	any additional costs incurred by Patheon in connection with the Services that are
required to fulfill applicable regulatory and contractual requirements.

	 	(e)	 	Client shall arrange for the pickup from the Patheon site of all materials and
supplies owned by Client within 5 days after the earlier of the completion, termination or
expiration of this Contract. Patheon shall charge a $30.00 per square foot per month
storage fee for all materials and supplies stored at the Patheon site after the fifth day
following the completion, termination or expiration of the Contract.

	5.	 	Intellectual Property:

	 	(a)	 	The term “Intellectual Property” includes, without limitation, rights in patents, patent
applications, formulae, trade-marks, trade-mark applications, trade-names, trade secrets,
inventions, copyright, industrial designs and know-how.
	 
	 	(b)	 	For the term of this Contract, Client hereby grants to Patheon, a non-exclusive,
paid-up, royalty-free, non-transferable license of Client’s Intellectual Property which
Patheon must use in order to perform the Services.
	 
	 	(c)	 	All Intellectual Property generated or derived by Patheon in the course of performing
the Services, to the extent it is specific to the development, manufacture, use and sale of
the Client’s Product that is the subject of the Services, shall be the exclusive property of
Client.
	 
	 	(d)	 	All Intellectual Property generated or derived by Patheon in the course of performing
the Services which are not specific

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	 	 	 	to, or dependent upon, Client’s Product and which have application to manufacturing
processes or formulation development of drug products or drug delivery systems shall be the
exclusive property of Patheon. Patheon hereby grants to Client, a non-exclusive, paid-up,
royalty-free, transferable license of such Intellectual Property which Client may use for the
manufacture of Client’s Product.

	6.	 	Indemnity:

	 	A.	 	Indemnification by Client

	 	 	Subject to Sections 6B and 6C(c), Client shall defend, indemnify and hold Patheon, its
affiliates and their respective directors, officers, employees and agents (collectively,
“Patheon Indemnitees”) harmless from and against any and all third-party actions, causes of
action, costs (including reasonable legal fees), claims, damages, liabilities and expenses
(collectively, “Losses”) relating to or arising from:

	 	•	 	the manufacture (except as may be contemplated by the Services) or distribution of the
Client’s Product or the use of the Client’s Product by patients either as part of or
outside of the scope of any clinical trials;
	 
	 	•	 	the performance of the Services in accordance with the terms of this Contract;
	 
	 	•	 	any misrepresentation, negligence or willful misconduct by Client or any of its
affiliates and their respective directors, officers, employees and agents (collectively,
“Client Indemnitees”);
	 
	 	•	 	any breach by the Client of the Client’s obligations or warranties under this Contract;
or
	 
	 	•	 	any claim of infringement or alleged infringement of any third party’s intellectual
property rights in respect of the Client’s Product.

	 	 	This indemnity shall not apply to the extent that such Losses are:

	 	•	 	determined to have
resulted from the negligence or willful misconduct of Patheon; or
	 
	 	•	 	for which Patheon is obligated to indemnify the Client
Indemnitees pursuant to Section
6B.

	 	B.	 	Indemnification by Patheon

	 	 	Subject to Sections 6A and 6C(c), Patheon shall defend, indemnify and hold the Client
Indemnitees harmless from and against any and all Losses resulting from, relating to or arising
from the breach by Patheon of any of its obligations or warranties under this Contract except
to the extent that such Losses are:

	 	•	 	determined to have resulted from the negligence or willful misconduct of Client; or
	 
	 	•	 	for which Client is obligated to indemnify the Patheon Indemnitees pursuant to
Section 6A.

	 	C.	 	Limitation of Liability
	 
	 	(a)	 	If Patheon fails to materially perform any part of the Services in accordance with the
terms of this Contract, then Client’s sole remedy, subject to subparagraph (b), shall be to
request Patheon to:

	 	•	 	repeat that part of the Service at Patheon’s costs provided that Client provides
the API; or
	 
	 	•	 	reimburse Client for the price for that part of the Service, excluding the cost
of the API.

	 	(b)	 	Under no circumstances whatsoever shall Patheon reimburse Client for the cost of the
API except as may otherwise be agreed in the event of Patheon’s gross negligence or
willful misconduct in respect of the API. Client acknowledges that the Services involve
scientific experiments that require the use of judgment and any loss of API in exercising
such judgment shall not be regarded as loss due to Patheon’s negligence or willful
misconduct.
	 
	 	(c)	 	Under no circumstances whatsoever shall either party be liable to the other in
contract, tort, negligence, breach of statutory duty or otherwise for (i) any (direct or
indirect) loss of profits, of production, of anticipated savings, of business or goodwill
or (ii) any other liability, damage, cost or expense of any kind incurred by the other
party of an indirect or consequential nature, regardless of any notice of the possibility of such
damages.

	 	D.	 	No Warranty

	 	 	PATHEON MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN
THOSE EXPRESSLY SET FORTH IN THIS CONTRACT. PATHEON MAKES NO WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY IN RESPECT OF THE
CLIENT’S PRODUCT.

	7.	 	 Regulatory Filings:

	 	(a)	 	Client shall have the sole responsibility for filing of all documents with the
applicable regulatory authority (such as the United States Food and Drug Administration
(“FDA”), the Health Products and Food Branch of Health Canada or the European Medicine
Evaluation Agency) (the “Regulatory Authority”) and to take any other actions that may be
required for the receipt of approval from the Regulatory Authority for the commercial
manufacture of the Client’s Product.
	 
	 	(b)	 	At least 21 days prior to filing any documents with the Regulatory Authority that
incorporate data generated by Patheon, Client shall provide Patheon with a copy of the
documents incorporating such data so as to give Patheon the opportunity to verify the
accuracy and regulatory validity of such documents as it relates to the Patheon-generated
data.
	 
	 	(c)	 	If Patheon is selected as the commercial site of manufacture of the Product which is
the subject of the Services under this Contract, then at least 21 days prior to filing with
the Regulatory Authority any documentation which is or is equivalent to the FDA’s
Chemistry and Manufacturing Controls (“CMC”) portion of the New Drug Application or of
the Abbreviated New Drug Application, as the case may be, Client shall provide Patheon
with a copy of the CMC portion as well as all supporting documents which have been relied
upon to prepare the CMC portion, Such disclosure shall permit Patheon to verify that
the CMC portion accurately describes the Services that Patheon has performed and the
manufacturing processes that Patheon will perform pursuant to this
Contract.

	8.	 	Shipping (if applicable):

Shipments
(if applicable) of Client’s Product shall be made EXW (as defined in INCOTERMS 2000)
Patheon’s shipping point unless otherwise mutually agreed. Risk of loss or of damage to such
Product shall transfer to the Client when the Product is loaded onto the carrier’s vehicle by
Patheon for shipment at the EXW point. The Product shall be transported in accordance with the
Client’s instructions.

	9.	 	Miscellaneous:

	 	A.	 	Assignment
	 
	 	 	 	Neither this Contract, nor any of either party’s rights hereunder, may be assigned or
otherwise transferred by either party without the prior written consent of the other party,
which consent shall not be unreasonably withheld.
	 
	 	B.	 	Force Majeure
	 
	 	 	 	Except for payment obligations, neither party will be responsible for delay or failure in
performance resulting from acts beyond the reasonable control and without the fault or
negligence of such party, including, but not limited to, strikes or other labor
disturbances, lockouts, quarantines, communicable disease outbreaks, riots, wars, acts of
terrorism, fires, floods, storms, interruption of or delay in transportation, defective
equipment, lack of or inability to obtain fuel, power or components or compliance with any
order or regulation of any government entity.
	 
	 	C.	 	Survival
	 
	 	 	 	Any termination or expiration of this Contract shall not affect any outstanding obligations
or payments due hereunder prior to such termination or expiration, nor shall it prejudice
any other remedies that the parties may have under this Contract. The Confidentiality
Agreement and sections 4, 5, 6 and 7 of

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	 	 	the Contract shall survive the expiration or termination of this
Contract.
	 
	D.	 	Independent Contractors
	 
	 	 	The parties are independent contractors and this Contract shall not
be construed to create between Patheon and the Client any other
relationship such as, by way of example only, that of employer-employee,
principal, agent, joint-venturer, co-partners or any similar relationship.
	 
	E.	 	Confidentiality
	 
	 	 	The Confidentiality Agreement entered into between the parties shall
apply to all confidential information about the parties and the Services
to be conducted under this Contract and such Confidentiality Agreement is
deemed to be incorporated herein by reference. If the Confidentiality
Agreement expires or terminates prior to the expiration or termination of
this Contract, then the terms of the Confidentiality Agreement shall
nonetheless continue to govern the parties’ obligations of
confidentiality for the term of this Contract and for 5 years thereafter.
	 
	F.	 	Patheon PartnerTM
	 
	 	 	In order to participate in the PatheonPartnerTM program, Client must
submit a completed PatheonPartnerTM External User Account/Access Form to
its Patheon project manager. If applicable, the PatheonPartnerTM External
User Account/Access Form signed by the Client shall apply to the Client’s
use of the PatheonPartnerTM website in respect of the Services.
	 
	G.	 	Other Terms
	 
	 	 	No terms, provisions or conditions of any purchase order or other
business form or written authorization used by Client or Patheon will
have any effect on the rights, duties or obligations of the parties, or
otherwise modify, this Contract, regardless of any failure of Client or
Patheon to object to such terms, provisions, or conditions unless such
document specifically refers to this Contract and is signed by both
parties.
	 
	H.	 	Insurance
	 
	 	 	Each party shall maintain during the term of this Contract general
liability and product liability insurance. Either party may request
evidence of such insurance.
	 
	I.	 	Entire Agreement
	 
	 	 	This Contract constitutes the complete agreement between the parties
with respect to this subject matter and supersedes all other prior
agreements and understandings, whether written or oral. Any
modifications, amendment or supplement to this Contract must be in
writing and signed by authorized representatives of both parties.
	 
	J.	 	Facsimile
	 
	 	 	This Contract may be signed in counterparts and by facsimile.
	 
	K.	 	Choice of Law
	 
	 	 	This Contract is governed by the laws of the State of Ohio without
regard to any conflicts-of-law principle that directs the application to
another jurisdiction’s law.

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Schedule B:

[FORM OF PROJECT PROPOSAL]

PROJECT PROPOSAL

UNDER

MASTER AGREEMENT FOR PHARMACEUTICAL DEVELOPMENT SERVICES

DATED • [insert date of master agreement]

PROPOSAL#•

 

	 	 	 	 	 
	1.

	 	 Product:
	 	• (“Product”)
	 
	 	 	 	 
	2.

	 	 Indication:
	 	•
	 
	 	 	 	 
	3.

	 	 Description of Services:
	 	See Project Scope (Part A).
	 
	 	 	 	 
	4.

	 	 Payment and Currency:
	 	See Budget Summary (Part B).
	 
	 	 	 	 
	5.

	 	 API Reimbursement

	 	[Not applicable] or
[$• per kilogram to a maximum of S.•]
	 

	 	 Amount per Clause	 	 
	 

	 	 6C(b) of Schedule A	 	 
	 

	 	 to Master Agreement:	 	 
	 
	 	 	 	 
	6.

	 	 Effective Date: 
	 	•, 200.
	 
	 	 	 	 
	7.

	 	 Term:
	 	From the Effective Date until completion by Patheon of the pharmaceutical development
services under this Project Proposal.
	 
	 	 	 	 
	8.

	 	 Date:
	 	•, 200.
	 
	 	 	 	 

	 	 	 	 	 	 	 	 	 	 	 
	Patheon Pharmaceuticals Inc.	 	 	 	Orexigen Therapeutics Inc.	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	 	 	 	 	By:	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	Name:

	 	 	 	 	 	Name:	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 
	Title:

	 	 	 	 	 	Title:	 	 	 	 
	 

	 	 

	 	 
	 	 	 	 

	 	 

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Part A: Project Scope

[project scope for Project to be inserted here]

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Part B: Budget Summary

[budget summary for Project to be inserted here]

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