Exhibit 10.1
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.
EXECUTION VERSION
LICENSE AGREEMENT
THIS LICENSE AGREEMENT (this “
Agreement ”) is entered into as of the 10th day of
June, 2009 (the “ Effective Date ”) by and
between SmithKline Beecham Corporation, doing business as
GlaxoSmithKline, a Pennsylvania corporation located at One Franklin
Plaza, Philadelphia, PA 19102 (“ SB ”), Glaxo
Group Limited, a private limited company incorporated in England
and Wales, having its registered office at Glaxo Wellcome House,
Berkeley Avenue, Greenford, Middlesex, England UB6 0NN (“
GGL ,” and together with SB, “ GSK
”) and Orexigen Therapeutics, Inc., a Delaware corporation
located at 3344 N. Torrey Pines Court, Suite 200, La Jolla,
California 92037 (“ Orexigen ”). GSK and
Orexigen are sometimes collectively referred to herein as the
“ Parties ” and separately as a “
Party .”
WHEREAS, GSK is the owner of all
right, title and interest in and to the Licensed Patents (as
hereinafter defined); and
WHEREAS, Orexigen desires to obtain
a non-exclusive license from GSK under the aforesaid Licensed
Patents to develop and commercialize Licensed Product in the Field
in the Territory (as each such term is hereinafter defined) as set
forth herein, and GSK is willing to grant Orexigen such
license.
NOW, THEREFORE, in consideration of
the mutual covenants and agreements set forth herein and other good
and valuable consideration, the receipt and legal sufficiency of
which are hereby mutually acknowledged, Orexigen and GSK hereby
agree as follows:
Article 1.
Definitions
.
Section 1.1 As used herein, the
following capitalized terms will have the meanings set forth below
when used in this Agreement, and all terms defined in the singular
will have the same meanings when used in the plural (and vice
versa), unless otherwise specified.
“ AAA ” will have
the meaning set forth in Section 10.1.
“ Affiliate(s) ”
of a Party or Person means any Person(s), whether directly or
indirectly, Controlling, Controlled by, or under common Control
with, such Party or Person, as applicable.
“ Agreement ”
will have the meaning set forth in the Preamble.
“ Applicable Law
” means all provisions of any and all federal, national,
state, provincial or local statutes, laws, rules, regulations,
administrative codes, ordinances, decrees, orders, decisions,
injunctions, awards judgments, permits and licenses of or from
governmental authorities in the Territory that apply to the use or
regulation of the Licensed Product.
“ Business Day ”
means any day other than a day that is a Saturday, a Sunday, a
federal holiday in the United States.
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“ Change of Control
” means the occurrence of any of the following
events:
(a) a merger or consolidation of
Orexigen with or into any other corporation or other entity or
person;
(b) a sale, exchange or other
transfer in one transaction or a series of related transactions of
all or substantially all of Orexigen’s assets;
(c) a liquidation or dissolution of
Orexigen; or
(d) a sale or transfer of
Orexigen’s voting securities in one transaction or a series
of related transactions that will result in the transfer of
ownership of fifty percent (50%) or more of the voting
securities of Orexigen or in one Person or an affiliated group of
Persons owning fifty percent (50%) or more of the voting
securities of Orexigen;
provided , that the following events shall not constitute
a “Change of Control”: (i) a merger, sale,
transfer or consolidation of Orexigen in which the holders of the
voting securities of Orexigen immediately prior to the merger,
sale, transfer or consolidation hold at least a majority of the
voting securities in the successor corporation immediately after
the merger or consolidation; (ii) a sale, lease, exchange or
other transaction in one transaction or a series of related
transactions of all or substantially all of Orexigen’s assets
to a wholly owned subsidiary corporation; (iii) a mere
reincorporation of Orexigen; or (iv) a transaction undertaken
for the sole purpose of creating a holding company that will be
owned in substantially the same proportion by the persons who held
Orexigen’s securities immediately before such transaction;
provided further, that in the cases of clauses (ii), (iii) and
(iv), such subsidiary, reincorporated entity or holding company
shall sign a joinder to this Agreement agreeing to be jointly and
severally responsible for all of Orexigen’s obligations and
liabilities hereunder.
“ Claim ” has the
meaning set forth in Section 10.2.
“ Confidential
Information ” means any and all information disclosed to
or obtained by the Parties pursuant to or in connection with the
negotiation, execution, delivery and performance of this Agreement
or the consummation of the transactions contemplated hereby and any
and all information regarding, related to, or associated with any
or all elements of this Agreement including the Licensed Patents;
provided, however, that Confidential Information will not include
information that: (i) at the time of disclosure is in the
public domain; (ii) after disclosure becomes part of the
public domain, except through breach of this Agreement;
(iii) a Party can demonstrate by reasonable proof was in its
possession prior to the time of disclosure by the other Party
hereunder, and was not acquired directly or indirectly from the
other Party; (iv) a Party can demonstrate by reasonable proof
was developed by or on behalf of such Party independent of and
without reference to the other Party’s Confidential
Information; or (v) becomes available to a Party from a Third
Party who did not acquire such information directly or indirectly
from the other Party and who is not otherwise prohibited from
disclosing such information.
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“ Control ” means
(i) direct or indirect ownership of more than fifty percent
(50%) of the equity (or such lesser percentage that is the
maximum allowed to be owned by a foreign corporation in a
particular jurisdiction) having the power to vote on or direct the
affairs of such Party or Person, as applicable, or (ii) the
power to direct decisions of such Party or Person, as applicable,
including, without limitation, the power to direct management and
policies of such Party or Person, as applicable, whether by reason
of ownership, by contract or otherwise (and the expressions “
Controlling ” and “ Controlled ”
shall be construed accordingly).
“ Disclosing Party
” will have the meaning set forth in
Section 5.1.
“ Dispute ” will
have the meaning set forth in Section 10.1.
“ Dispute Notice
” will have the meaning set forth in
Section 10.1.
“ Effective Date
” will have the meaning set forth in the Preamble.
“ FDA ” means the
United States Food and Drug Administration.
“ Field ” means
the treatment of obesity and disorders of weight
management.
“ GSK ” will have
the meaning set forth in the Preamble.
“ GSK Indemnitees
” will have the meaning set forth in
Section 10.2.
“ Indemnitee ”
will have the meaning set forth in Section 10.4.
“ Indemnitor ”
will have the meaning set forth in Section 10.4.
“ Licensed Patents
” means (i) [***]; any foreign equivalents of the
aforesaid patents; any patents claiming priority therefrom or
common priority therewith; and all divisions, continuations,
continuations-in-part, provisionals, reissues, reexaminations,
substitutions or extensions thereof, whether foreign or domestic,
and any patents that issue thereon, and any reissues,
reexaminations renewals or extensions (including any supplemental
protections certificate) of any such patent, including all foreign
counterparts of any of the foregoing.
“ Licensed Product
” means the prescription pharmaceutical product owned or
controlled by Orexigen with the trade name “Contrave
® ” and [***].
“ Losses ” will
have the meaning set forth in Section 10.2.
“ Major Market ”
means any of the United Kingdom, Germany, France, Italy and
Spain.
“ New Drug Application
” means a New Drug Application filed with the FDA including a
505(b)(2) application.
“ Orexigen ” will
have the meaning set forth in the Preamble.
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Certain
information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to omitted portions.
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“ Orexigen Indemnitees
” will have the meaning set forth in
Section 10.3.
“ Product Partnering
Agreement ” will have the meaning set forth in Section
3.1.
“ Party ” or
“ Parties ” will have the meaning set forth in
the Preamble.
“ Person ” means
any individual, corporation, partnership, firm, association, joint
venture, joint stock company, trust or other entity, or any
government or regulatory administrative or political subdivision or
agency, department or instrumentality thereof.
“ Receiving Party
” will have the meaning set forth in
Section 5.1.
“Regulatory Approval”
means marketing approval from the FDA or from agencies in foreign
jurisdictions that provide approval for marketing or distributing
drugs in those jurisdictions.
“ Royalty(ies) ”
will have the meaning set forth in Section 3.1.
“ Sublicense ”
means the sublicense agreement with any Sublicensee.
“ Sublicensee ”
will have the meaning set forth in Section 2.2.
“ Term ” will
have the meaning set forth in Section 8.1.
“ Territory ”
means all countries and territories in the world.
“ Third Party ”
means any Person other than the Parties.
“ Trade Dress ”
means any and all designs, colors, graphics and Trademarks of
Licensed Product packaging, these elements either separately or
together in combination thereof.
“ Trademark ”
means any and all trademarks, service marks, words, phrases,
slogans, designs, logos and combinations thereof used as an
indication of source of Licensed Product or associated services or
products.
“ United States ”
or “ U.S. ” means the fifty (50) states of
the United States of America, its territories and the District of
Columbia.
Section 1.2 The word “
including ” or any variation thereof means
“including without limitation” and will not be
construed to limit any general statement that it follows to the
specific or similar items or matters immediately following
it.
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Article 2. Patent License Grant; Covenant Not to
Sue.
Section 2.1 Non-Exclusive
Patent License Grant .
(i) Subject to the terms and
conditions of this Agreement, including, without limitation,
Section 11.3(vi), GSK, on behalf of itself and its Affiliates,
hereby grants to Orexigen a non-exclusive license, with the right
to grant sublicenses solely for the purposes as set forth in
Section 2.2, under the Licensed Patents, to make, have made,
use, sell, offer for sale and import and to file for and obtain
Regulatory Approval for Licensed Product in the Field in the
Territory.
(ii) Without prejudice to the
provisions of Section 2.5, Orexigen expressly acknowledges and
agrees that except as set forth in Section 2.1(i), neither GSK
nor any of its Affiliates is in any way granting to Orexigen or any
of its Affiliates or Sublicensees any rights under any patents or
patent applications other than the Licensed Patents that are or may
become owned by GSK or any of its Affiliates, or to which GSK or
any of its Affiliates otherwise has, now or in the future the right
to grant licenses and license rights or sublicenses and sublicense
rights. Further, Orexigen expressly acknowledges and agrees that
(a) the non-exclusive license under the Licensed Patents
granted by GSK to Orexigen as provided in Section 2.1(i) is
solely with respect to the making, having made, using, selling,
offering for sale and importing of and filing for and obtaining
Regulatory Approval of Licensed Product in the Field in the
Territory; and (b) the non-exclusive license under the
Licensed Patents granted by GSK to Orexigen as provided in
Section 2.1(i) is in no way deemed directly or impliedly to be
a license under, and Orexigen disclaims all direct or implied
rights under, the Licensed Patents or any other patents that, in
each case, are or may become owned by GSK or any of its Affiliates,
or to which GSK or any of its Affiliates otherwise has, now or in
the future, that are related to, regarding or associated in any way
with the making, having made, using, selling, offering for sale or
importing of any pharmaceutical product or formulation within and
without the Field and within and without the Territory, other than
the Licensed Product.
Section 2.2 Sublicense of
Rights . Subject to the terms and conditions of this Agreement,
the Parties agree that Orexigen may (without the consent of GSK)
sublicense, without the right to further sublicense, any or all of
its rights under this Agreement (including but not limited to those
set forth in Section 2.1) to a Third Party solely (i) in
connection with Regulatory Approval for the Licensed Product for
Orexigen or (ii) in connection with a Product Partnering
Agreement (any such party, a “ Sublicensee ”).
Orexigen acknowledges and agrees that in no event will the
Sublicense to any Sublicensee of any or all of its rights under
this Agreement be deemed to relieve Orexigen of its liabilities or
obligations to GSK under this Agreement. Orexigen expressly
acknowledges and agrees that it will remain fully and
unconditionally obligated and responsible for the full and complete
performance of all of its obligations under the terms and
conditions of this Agreement. In the event that Orexigen elects to
sublicense as provided in this Section 2.2(ii), it will
provide GSK with written notice thereof, which notice will include
the identity and address of any Sublicensee, prior to the execution
of any such Sublicense by Orexigen. Orexigen represents and
warrants that the terms of any such Sublicense will refer to this
Agreement and Orexigen shall ensure that none of the terms of such
Sublicense shall conflict with the terms of this Agreement. In the
event of a conflict between the terms of this Agreement and the
terms of such Sublicense, as between Orexigen and GSK, and/or as to
any rights and/or obligations under this Agreement that are
sublicensed to any Sublicensee as provided herein, the terms of
this Agreement will prevail.
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Section 2.3 Affiliates .
Either Party may contract or agree with one or more of its
Affiliates to have such Affiliate perform any of such Party’s
obligations herein. In no event will such use of an Affiliate be
deemed to relieve a Party of its liabilities or obligations to the
other Party under this Agreement. Each Party expressly acknowledges
and agrees that it will remain fully and unconditionally obligated
and responsible for the full and complete performance of all of its
obligations under the terms and conditions of this Agreement,
whether or not such performance is carried out by such Party or any
of its Affiliates.
Section 2.4 Covenant Not to
Sue of Orexigen . During the term of this Agreement (and as
further provided in Section 8.4), Orexigen represents and
warrants that neither it nor any of its Affiliates will initiate or
bring, nor will it or any of its Affiliates assist in any way any
Person in pursuing, a lawsuit, proceeding, interference or any
other action of any kind whatsoever that either (i) seeks a
judicial determination that the Licensed Product does not infringe
on any of the Licensed Patents, or (ii) challenges the
validity, enforceability or scope of any of the Licensed Patents,
provided , that this Section 2.4 shall not apply in the
event that GSK or any of its Affiliates breaches the covenant not
to sue in Section 2.5.
Section 2.5 Covenant Not to
Sue of GSK . During the term of this Agreement, GSK represents
and warrants that neither it nor any of its Affiliates will, under
the Licensed Patents, initiate or bring a lawsuit, proceeding or
other action of any kind whatsoever that claims that the making,
having made, using, selling, offering for sale or importing, or
seeking, obtaining or maintaining Regulatory Approval of, Licensed
Product in the Field in the Territory by Orexigen, any of its
Affiliates or any permitted Sublicensee is infringing the Licensed
Patents, provided , that this Section 2.5 shall not
apply in the event that Orexigen or any of its Affiliates breaches
the covenant not to sue in Section 2.4.
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Article 3. Royalty Payments to GSK .
Section 3.1 Royalties .
In consideration for the non-exclusive license under the Licensed
Patents granted to Orexigen by GSK pursuant to Section 2.1,
Orexigen will make the following royalty payments (the “
Royalties ”) to GSK in the amounts and in the manner
specified below, within [***] ([***]) days after the milestones
specified below:
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Milestones
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Royalty
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(1) Effective Date
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U.S.
$[***]
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(2) The earliest to occur of:
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U.S. $[***]
(the “ Second Royalty Payment ”)
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(a) [***];
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(b) [***];
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(c) [***]; or
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(d) [***]
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Section 3.2 Royalty Payment
Provisions .
(i) All Royalties are
non-refundable.
(ii) All Royalties shall be paid by
Orexigen, in U.S. Dollars, by wire transfer of immediately
available funds to GSK’s account listed on Exhibit A ,
or to such other account as GSK designates in writing to Orexigen.
Orexigen shall send written confirmation of such payments of
Royalties at the time they are made to the addresses set forth in
Section 11.1.
(iii) In no event shall Orexigen
have any right to reclaim any Royalties already paid to
GSK.
(iv) The Royalties shall be
internally allocated by GSK as follows: [***]% to SB and [***]% to
GGL.
Article 4.
Product Development and
Commercialization . As of the Effective Date and during the Term,
Orexigen will have full control, authority and responsibility over
research, development, registration, manufacture,
commercialization, marketing and sale of all Licensed Product in
each country in the Field in the Territory, and all such activity
will be undertaken at Orexigen’s sole expense and
discretion.
Article 5.
Confidential Information
.
Section 5.1 Confidential
Information . During the Term, and for a period of five
(5) years after the effective date of the expiration or
earlier termination of this Agreement for any permitted reason
contained herein, the Parties agree that:
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information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has
been requested with respect to omitted portions.
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(i) The Parties will not disclose,
directly or indirectly, in any manner whatsoever to any Third
Parties any Confidential Information received from the other Party
(the “ Disclosing Party ”) without first
obtaining the written consent of the Disclosing Party which such
consent shall not be unreasonably withheld, conditioned or delayed,
and the Parties will keep confidential, all of the Disclosing
Party’s Confidential Information that is disclosed to such
Party (the “ Receiving Party ”), provided that a
Party may disclose the specific terms of this Agreement (a) to
attorneys, accountants, advisors, lenders, investors and bona fide
prospective lenders and investors who are bound by obligations of
confidentiality no less restrictive than those set forth herein or
who are otherwise bound by ethical or other similar obligations, or
(b) pursuant to business discussions wherein a letter of
intent or binding agreement has been executed or a term sheet has
been completed relating to a sale of substantially all the assets
of Orexigen, an equity investment in Orexigen, a merger, a
sublicense permitted hereunder, or a Change of Control, so long as
such discussions are subject to a nondisclosure agreement. The
Receiving Party agrees to use the same level of care in
safeguarding the Disclosing Party’s Confidential Information
that the Receiving Party uses with its own confidential information
of a similar nature, but in no event less than reasonable care. The
Receiving Party will restrict disclosure of the Disclosing
Party’s Confidential Information solely to those of its (or
its Affiliates’ or any Sublicensee’s) employees or
representatives having a need to know such Confidential Information
in order to accomplish the purposes of this Agreement. The
Receiving Party represents that its employees and representatives
who will have access to the Disclosing Party’s Confidential
Information are bound by an obligation to maintain such
Confidential In