Exhibit 10.4
CERTAIN CONFIDENTIAL PORTIONS OF
THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A
COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE
SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN
APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE
SECURITIES ACT OF 1933.
PATENT AND TECHNOLOGY LICENSE
AGREEMENT
This AGREEMENT
(“AGREEMENT”) is made on this 14th day of December,
2010, by and between THE BOARD OF REGENTS (“BOARD”) of
THE UNIVERSITY OF TEXAS SYSTEM (“SYSTEM”), an agency of
the State of Texas, whose address is 201 West 7th Street, Austin,
Texas 78701, on behalf of THE UNIVERSITY OF TEXAS M. D. ANDERSON
CANCER CENTER (“UTMDACC”), a member institution of
SYSTEM, and ARROWHEAD RESEARCH CORPORATION a Delaware corporation
having a principal place of business located at 201 South Lake
Avenue, Suite 703, Pasadena, CA 91101
(“LICENSEE”).
RECITALS
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A.
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BOARD owns
certain PATENT RIGHTS and TECHNOLOGY RIGHTS related to LICENSED
SUBJECT MATTER developed at UTMDACC.
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B.
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BOARD, through
UTMDACC, desires to have the LICENSED SUBJECT MATTER developed in
the LICENSED FIELD and used for the benefit of LICENSEE, BOARD,
SYSTEM, UTMDACC, the inventor(s), and the public as outlined in
BOARD’s Intellectual Property Policy.
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C.
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LICENSEE wishes
to obtain a license from BOARD to practice LICENSED SUBJECT
MATTER.
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NOW, THEREFORE, in consideration of
the mutual covenants and promises herein contained, the parties
agree as follows:
I. EFFECTIVE DATE
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1.1
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This AGREEMENT
is effective as of the date written above (“EFFECTIVE
DATE”) which is the date fully executed by all
parties.
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1
II. DEFINITIONS
As used in this AGREEMENT, the
following terms have the meanings indicated:
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2.1
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AFFILIATE means any business entity more than fifty
percent (50%) owned by LICENSEE, any business entity which
owns more than fifty percent (50%) of LICENSEE, or any
business entity that is more than fifty percent (50%) owned by
a business entity that owns more than fifty percent (50%) of
LICENSEE.
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2.2
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IMPROVEMENT (s) means BOARD’s rights in any invention
that is an improvement or modification to the PATENT RIGHTS in the
LICENSED FIELD, that cannot be practiced without infringing a claim
of any issued patent or pending application under the PATENT
RIGHTS, and that:
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(1)
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is conceived
and reduced to practice solely by Wadih Arap, M.D., Ph.D. and/or
Renata Pasqualini, Ph.D., and/or any UTMDACC lab personnel working
solely under the supervision of either of them, while both are
employed solely by UTMDACC, and is conceived and reduced to
practice solely at UTMDACC-owned facilities; and
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(2)
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is conceived
and reduced to practice within five (5) years of the EFFECTIVE
DATE; and
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(3)
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is not
obligated, in whole or in part, to a third party in any field of
use and is owned solely by the BOARD; and
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(4)
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is disclosed to
UTMDACC’s Office of Technology Commercialization
“OTC”) in accordance with UTMDACC’s Intellectual
Property Policy or is otherwise disclosed to OTC.
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2
Notwithstanding the foregoing,
IMPROVEMENTS shall not include any improvement or modification
involving or related to the EXCLUDED PEPTIDES/FRAGMENTS.
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2.3
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IND means the application submitted to the United
States Food and Drug Administration (“FDA”) for
approval to conduct a clinical investigation with an
investigational new drug, as more specifically defined by 21 C.F.R.
§312 et seq., or any future revisions or substitutes thereof,
or an equivalent application filed with any equivalent regulatory
agency or governmental authority in any jurisdiction other than the
United States.
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2.4
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LICENSED FIELD
means the fields of:
(A) therapeutics, diagnostics and research products and
services that satisfy both of the following criteria: (1) the
products and services incorporate peptides that specifically target
receptors on adipose tissue or vasculature associated with adipose
tissue; and (2) the products and services are used to treat,
diagnose or research solely the following: (a) obesity and
overweight; and/or (b) metabolic conditions related to, caused
by, and/or associated with obesity and overweight; and
(B) cancer therapeutics, cancer diagnostics and cancer
research products and services, involving the direct or indirect
use of any of the *** peptide, any functional fragments thereof, or
any derivatives or functional analogs of any such peptides or
fragments. Notwithstanding the foregoing, the LICENSED FIELD shall
not include any field that involves the direct or indirect use of
any of the following peptides, any functional fragments thereof, or
any derivatives, or analogs of any such peptides or fragments
(including any compositions, products, processes,
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methods, or services comprising
or incorporating any of the foregoing peptides, fragments,
derivatives or analogs (collectively, the ***): (1) the ***;
(2) the ***; (3) the ***; (4) the ***; (5) the
***; and (6) the ***.
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2.5
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LICENSED
PRODUCTS means any
product or service sold by LICENSEE or its AFFILIATES or their
sublicensees comprising LICENSED SUBJECT MATTER pursuant to this
AGREEMENT.
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2.6
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LICENSED
SUBJECT MATTER means
inventions and discoveries covered by PATENT RIGHTS or TECHNOLOGY
RIGHTS within LICENSED FIELD.
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2.7
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LICENSED
TERRITORY means
worldwide.
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2.8
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MARKETING APPROVAL means the approval required by
the United States Food and Drug Administration (“FDA”)
in the United States, or an equivalent regulatory agency or
governmental authority in any jurisdiction other than the United
States, to market and sell a LICENSED PRODUCT in such
jurisdiction.
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2.9
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NDA means a New Drug Application or Biologics
License Application filed with the FDA in connection with obtaining
MARKETING APPROVAL, or an equivalent application filed with any
equivalent regulatory agency or governmental authority in any
jurisdiction other than the United States.
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2.10
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NET SALES
means the gross revenues received by
LICENSEE or its AFFILIATES or their sublicensees from a SALE less
sales discounts actually granted, sales and/or use taxes actually
paid, import and/or export duties actually
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paid, outbound transportation
actually prepaid or allowed, and amounts actually allowed or
credited due to returns (not exceeding the original billing or
invoice amount), all as recorded by LICENSEE or its AFFILIATES or
their sublicensees in their official books and records in
accordance with generally accepted accounting practices and
consistent with their published financial statements and/or
regulatory filings with the United States Securities and Exchange
Commission.
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2.11
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PATENT
RIGHTS means
BOARD’s rights in the information or discoveries described in
invention disclosures, or claimed in any patents and/or patent
applications, whether domestic or foreign, as identified in Exhibit
I attached hereto, and all divisionals, continuations,
continuations-in-part (to the extent the claims of such
continuations-in-part are entitled to claim priority to the
aforesaid patents and/or patent applications identified in Exhibit
I), reissues, reexaminations or extensions of the patents and/or
patent applications identified in Exhibit I, and any letters
patent, domestic or foreign, that issue thereon.
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2.12
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PHASE I
CLINICAL STUDY means:
(a) that portion of the FDA submission and approval process
which provides for the first introduction into humans of a product
with the purpose of determining human toxicity, metabolism,
absorption, elimination and other pharmacological action, as more
fully defined by the rules and regulations of the FDA, including 21
C.F.R. § 312.21(a) or any future revisions or substitutes
therefor; or (b) a similar clinical study in any jurisdiction
other than the United States.
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2.13
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PHASE II
CLINICAL STUDY means:
(a) that portion of the FDA submission and approval process
which provides for early controlled clinical studies conducted to
obtain preliminary data on the effectiveness of a product for a
particular indication, as more specifically defined by the rules
and regulations of the FDA, including 21 C.F.R. § 312.21(b) or
any future revisions or substitutes therefor; or (b) a similar
clinical study in any jurisdiction other than the United
States.
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2.14
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PHASE III
CLINICAL STUDY means:
(a) that portion of the FDA submission and approval process in
which expanded clinical trials are conducted to gather the
additional information about effectiveness and safety that is
needed to evaluate the overall benefit-risk relationship of a
product, as more specifically defined by the rules and regulations
of the FDA, including 21 C.F.R. § 312.21(c) or any future
revisions or substitutes therefor; or (b) a similar clinical
study in any jurisdiction other than the United States.
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2.15
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SALE or SOLD means the transfer or disposition
of a LICENSED PRODUCT for value to a party other than LICENSEE, an
AFFILIATE or a ROYALTY-FREE PRACTITIONER. As used herein,
“ROYALTY-FREE PRACTITIONER” means UTMDACC and the
following individuals: Wadih Arap, M.D., Ph.D. and Amado
Zurita-Saavedra, M.D. (“PHYSICIAN INVENTORS”), and any
partner or associate who practices medicine with one or more of the
PHYSICIAN INVENTORS, but with respect to such partner or associate,
only for such time as he/she is engaged in a bona fide medical
practice with one or more of the PHYSICIAN INVENTORS.
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2.16
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TECHNOLOGY
RIGHTS means
BOARD’s rights in any technical information, know-how,
processes, procedures, compositions, devices, methods, formulae,
protocols, techniques, software, designs, drawings or data created
by the inventor(s) listed in Exhibit I at UTMDACC before the
EFFECTIVE DATE, which are not claimed in PATENT RIGHTS but that are
necessary for practicing PATENT RIGHTS.
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2.17
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VALID
CLAIM means: (a) a
claim of any issued, unexpired patent that has not been revoked or
held unenforceable or invalid by a decision of a court or
governmental agency of competent jurisdiction from which no appeal
can be taken, or with respect to which an appeal is not taken
within the time allowed for appeal, and that has not been
disclaimed or admitted to be invalid or unenforceable through
reissue, disclaimer or otherwise; or (b) a claim of any
pending or published patent application that that has not been
cancelled, withdrawn or abandoned and that has not been pending for
more than five (5) years from the filing date of the earliest
patent application from which the pending or published application
containing such claim claims priority. For purposes of
clarification, if a claim in an application has been pending for
more than five (5) years from its priority date, and a patent
subsequently issues containing such claim, then upon issuance of
the patent, the claim shall thereafter be considered a VALID
CLAIM.
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III. LICENSE
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3.1
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BOARD, through
UTMDACC, hereby grants to LICENSEE a royalty-bearing, exclusive
license under LICENSED SUBJECT MATTER to manufacture, have
manufactured, use, import, offer to sell and/or sell LICENSED
PRODUCTS within LICENSED TERRITORY for use within LICENSED FIELD.
This grant is subject to Sections 14.1, 14.2 and 14.3 hereinbelow,
the payment by LICENSEE to UTMDACC of all consideration as provided
herein, the timely payment of all amounts due hereunder, and is
further subject to the following rights retained by BOARD and
UTMDACC to:
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(a)
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Publish the
general scientific findings from research related to LICENSED
SUBJECT MATTER, subject to the terms of ARTICLE
XI–Confidential Information and Publication; and
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(b)
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Use LICENSED
SUBJECT MATTER for: (1) commercial and non-commercial
research; and (2) teaching, patient care, and other
academically-related purposes; provided however, that BOARD and
UTMDACC shall not engage in commercial research that is
specifically directed to the use of PATENT RIGHTS and/or TECHNOLOGY
RIGHTS in the LICENSED FIELD. BOARD and UTMDACC may engage in
general commercial research with respect to PATENT RIGHTS and
TECHNOLOGY RIGHTS and in commercial research in fields of use other
than the LICENSED FIELD.
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3.2
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LICENSEE may
extend the license granted herein to any AFFILIATE provided that
the AFFILIATE consents in writing to be bound by this AGREEMENT to
the same extent as LICENSEE. LICENSEE agrees to deliver such
contract to UTMDACC within thirty (30) calendar days following
execution thereof.
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3.3
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LICENSEE may
grant sublicenses under LICENSED SUBJECT MATTER consistent with the
terms of this AGREEMENT provided that LICENSEE is responsible for
its sublicensees relevant to this AGREEMENT, and for diligently
collecting all amounts due LICENSEE from sublicensees. If a
sublicensee pursuant hereto becomes bankrupt, insolvent or is
placed in the hands of a receiver or trustee, LICENSEE, to the
extent allowed under applicable law and in a timely manner, agrees
to use its best commercially reasonable efforts to collect all
consideration owed to LICENSEE and to have the sublicense agreement
confirmed or rejected by a court of proper jurisdiction.
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3.4
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LICENSEE must
deliver to UTMDACC a true and correct copy of each sublicense
granted by LICENSEE, and any modification or termination thereof,
within sixty (60) calendar days after execution, modification,
or termination.
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3.5
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If this
AGREEMENT is terminated pursuant to ARTICLE XIII-Term and
Termination, BOARD and UTMDACC agree to accept as successors to
LICENSEE, existing sublicensees in good standing at the date of
termination provided that each such sublicensee consents in writing
to be bound by all of the terms and conditions of this
AGREEMENT.
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3.6
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UTMDACC shall
promptly disclose any IMPROVEMENTS to LICENSEE. LICENSEE shall have
ninety (90) days from the date of such disclosure to notify
UTMDACC in writing whether LICENSEE desires to include such
IMPROVEMENTS under this AGREEMENT. If LICENSEE desires to include a
disclosed IMPROVEMENT in this AGREEMENT, the parties shall enter
into an amendment to this AGREEMENT adding BOARD’s rights in
such IMPROVEMENT to Exhibit I, giving LICENSEE a license to such
IMPROVEMENT in the LICENSED FIELD. LICENSEE will reimburse UTMDACC
for all documented legal and filing fees incurred by UTMDACC
relating to any IMPROVEMENT added to this AGREEMENT. If LICENSEE
does not send written notice to UTMDACC of its desire to add the
IMPROVEMENT to the AGREEMENT prior to expiration of the ninety
(90) day period, then thereafter UTMDACC shall have the right
to freely license the IMPROVEMENT to third parties, with no further
obligation or consideration due to LICENSEE. In the event an
IMPROVEMENT is added to the AGREEMENT pursuant to this
Section 3.6, the term “EFFECTIVE DATE” as used in
Section 2.16 for purposes of defining the TECHNOLOGY RIGHTS
related to such IMPROVEMENT shall be deemed to be the effective
date of the amendment adding such IMPROVEMENT to this
AGREEMENT.
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IV. CONSIDERATION, PAYMENTS AND
REPORTS
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4.1
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In
consideration of rights granted by BOARD to LICENSEE under this
AGREEMENT, LICENSEE agrees to pay UTMDACC the following:
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(a)
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All documented legal and filing
fees incurred by UTMDACC after the EFFECTIVE DATE in filing,
prosecuting, and maintaining PATENT RIGHTS, and all such future
expenses incurred by UTMDACC, for so long as, and in such countries
as this AGREEMENT remains in effect (“PATENT
EXPENSES”). Notwithstanding the foregoing, in the event that
there are other entities with licenses to both of the technologies
listed on Exhibit I in other fields of use (“ADDITIONAL
LICENSEES”), then LICENSEE shall be obligated to pay only a
pro rata share of the PATENT EXPENSES as follows. LICENSEE’s
pro rata share shall be
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