Exhibit 10.16
[********] Certain confidential information
contained in this document, marked by brackets, has been omitted
and filed separately with the Securities and Exchange Commission
pursuant to Rule 406 of the Securities Act of 1933, as
amended.
TARGACEPT CONTRACT NO. 03-060-0147
AMENDED AND
RESTATED
LICENSE AGREEMENT
This Amended and Restated License
Agreement (this “ Agreement ”) is made and
entered into to be effective the 9th day of March 2004, by and
between the UNIVERSITY OF SOUTH FLORIDA RESEARCH FOUNDATION, INC.,
a corporation not for profit under Chapter 617 of the Florida
Statutes and a direct support organization of the University of
South Florida (“ University ”) pursuant to
Section 1004.28 of the Florida Statutes, having its principal
office at 4202 East Fowler Avenue, Tampa, Florida 33620, U.S.A.
(hereinafter referred to as “ RESEARCH FOUNDATION
”), and Targacept, Inc., a Delaware Corporation, having its
principal office at 200 East First Street, Suite 300,
Winston-Salem, North Carolina 27101-4165 (hereinafter referred to
as “ LICENSEE ”) and amends and restates in its
entirety the License Agreement dated October 13, 1997, as amended,
between RESEARCH FOUNDATION and LICENSEE, as assignee of Layton
Bioscience, Inc. (the “ Original Agreement
”).
WITNESSETH
WHEREAS, RESEARCH FOUNDATION is the
exclusive licensee of certain “Patent Rights” (as later
defined herein) relating to the use of mecamylamine to treat
neuropsychiatric disorders and has the right to grant licenses
under said Patent Rights;
WHEREAS, RESEARCH FOUNDATION desires
to have the Patent Rights utilized in the public interest and is
willing to grant a license thereunder; and
WHEREAS, LICENSEE intends to
develop, produce, manufacture, market and/or sell “Licensed
Product(s)” (as later defined herein) and is willing to
commit itself to a diligent program of exploiting the Patent Rights
so that public utilization shall result therefrom; and
WHEREAS, LICENSEE desires to obtain
a license under the Patent Rights upon the terms and conditions
hereinafter set forth.
NOW, THEREFORE, in consideration of
the premises and the mutual covenants contained herein, the parties
hereto agree as follows:
ARTICLE I.
DEFINITIONS
For the purposes of this Agreement,
the following words and phrases shall have the following
meanings:
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1.1
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“Annual
License Fee” shall mean [********] , and “Annual
Rights Fee” means [********] .
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1.2
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“Competition” shall, with respect to
any Licensed Product, be deemed to exist in a particular country
for and after the first calendar quarter in which [********]
.
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1.3
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“Competitive Product” shall mean,
with respect to any Licensed Product, any pharmaceutical product
containing an active ingredient that is the same compound as a
Named Compound contained in or comprising such Licensed Product, or
any analog, salt, solvate, prodrug form, inclusion complex or
metabolite thereof, that [********] .
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1.4
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“Confidential Information” shall
mean, subject to Paragraph 15.3, information that is confidential,
proprietary or otherwise not generally available to the
public.
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1.5
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“Effective Date” shall mean the date
so identified above in the preamble to this Agreement.
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1.6
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“Improvement” shall mean, with
respect to any Licensed Product, technology that [********]
.
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1.7
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“Licensed
Process” shall mean any process that relates to a Named
Compound and infringes or would infringe, in whole or in part, a
Valid Claim contained in the Patent Rights.
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1.8
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“Licensed
Product” shall mean any product or part thereof containing or
comprising a Named Compound that:
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(a)
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infringes or
would infringe, in whole or in part, a Valid Claim contained in the
Patent Rights in the country in which such product or part thereof
is made, used, leased or sold; or
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(b)
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is made by a
process that is a Licensed Process in the country in which such
product is made, used or sold.
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1.9
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“LICENSEE” shall include, in
addition to Targacept, Inc.: a related company of Targacept, Inc.,
the voting stock of which is, directly or indirectly, at least
fifty percent (50%) owned or controlled by Targacept, Inc.; an
organization which directly or indirectly controls more than fifty
percent (50%) of the voting stock of Targacept, Inc.; and an
organization, the majority ownership of which is, directly or
indirectly, common to the ownership of Targacept, Inc.. References
in this Paragraph 1.9 to “voting stock” shall mean
capital stock entitled to vote in the election of the board of
directors or the analogous body of a noncorporate
entity.
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1.10
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“Losses” shall mean all claims and
expenses, including reasonable attorneys’ fees, actually
incurred.
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1.11
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“Milestones” shall mean events
defined in Appendix B .
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1.12
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“Named
Compounds” shall mean [********] .
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1.13
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“NDA
Filing Date” shall mean the date on which LICENSEE (or its
sublicensee or collaborative partner) files its first New Drug
Application (or its equivalent) with the United States Food and
Drug Administration or any comparable foreign regulatory authority
for the use of a Licensed Product to treat attention deficit
hyperactivity disorder and/or any other neuropsychiatric disease or
disorder in any country.
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1.14
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“Net
Sales” shall mean [********] .
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1.15
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“Option
Invention” shall mean any discovery, compound, improvement,
invention, idea, process or technique, whether or not patentable,
that (i) is made, conceived or first reduced to practice by
RESEARCH FOUNDATION and (ii) without regard to any rights reserved
under Paragraph 2.2, cannot reasonably be practiced without
infringing the Patent Rights licensed to LICENSEE
hereunder.
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1.16
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“Patent
Rights” shall mean, collectively, (i) the patents and patent
applications listed on Appendix A , (ii) all patents that
issue from patent applications listed on Appendix A and all
reexaminations, reissues, revisions, substitutes, renewals or
extensions thereof, and (iii) all other United States and foreign
patents that issue from applications that claim priority to patents
and patent applications listed on Appendix A , including,
without limitation, continuation applications, continuation-in-part
applications, divisional applications, substitute applications,
reissue applications or requests for examination and foreign
applications of any of the foregoing.
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1.17
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“Special
Issue Dispute” shall mean a dispute between the parties as to
whether (i) LICENSEE is meeting its diligence obligation hereunder
or (ii) a condition that would give rise to a royalty reduction
under Paragraph 4.1(b)(i) or 4.1(c) has occurred or been
met.
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1.18
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“Sublicense Fees” shall mean any
fees (including the fair market value of any consideration paid
other than in cash) received by LICENSEE for a sublicense of Patent
Rights, excluding (i) running royalties on the sale or lease of
Licensed Products, (ii) payments specifically allocated to research
and development for, or to the manufacture or supply of, a Licensed
Product or Licensed Process, (iii) amounts received by LICENSEE
that it is required to repay (e.g., a loan) and (iv) payments
received in exchange for securities of LICENSEE.
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1.19
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“Substantial LICENSEE IP Rights”
shall mean any issued patent or pending patent application owned or
licensed by LICENSEE that claims an Improvement, but excluding
Improvements for which both LICENSEE and RESEARCH FOUNDATION
provided independent inventive contribution.
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1.20
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“Territory” shall mean the
world.
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1.21
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“Valid
Claim” shall mean: (i) any claim of an issued patent that has
not expired and that has not been held invalid or unenforceable by
decision of a court or other governmental agency of competent
jurisdiction or been admitted to be invalid through reissue,
disclaimer or otherwise; or (ii) any claim of a pending patent
application that has not expired or become canceled, abandoned or
otherwise disallowed.
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ARTICLE II.
GRANT
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2.1
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(a) RESEARCH
FOUNDATION hereby grants to LICENSEE the perpetual, exclusive right
and license under the Patent Rights to research, develop, make,
have made, use, market, distribute, lease, sell, import and export
Licensed Products and Licensed Processes for any and all
indications in the Territory, with the right to practice all or any
portion of the foregoing right and license through subcontractors
which, unless specifically sublicensed hereunder, shall not be
considered sublicensees hereunder.
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(b) In the event that RESEARCH
FOUNDATION receives a bona fide third party offer whereby
such third party would obtain a right or license under any of the
Patent Rights for any purpose not exclusively licensed to LICENSEE
hereunder (the “ Subject Rights ”), (i) RESEARCH
FOUNDATION shall notify LICENSEE of all material terms of such
offer in writing (the “ Subject Notice ”) within
ten (10) business days after its receipt by RESEARCH FOUNDATION,
which notice shall certify as to the receipt of such offer from a
bona fide third party, and (ii) LICENSEE shall thereupon
have a right of refusal to license the Subject Rights on the same
terms set forth in the Subject Notice. LICENSEE may exercise its
right of first refusal at any time within [********] after
its receipt of the Subject Notice by written notice to RESEARCH
FOUNDATION, and, in such event, the parties shall work diligently
towards execution of a definitive license agreement reflecting the
terms in the Subject Notice and, to the extent not inconsistent,
the terms hereof; provided that, if mutually acceptable, the
parties may elect instead to amend and restate this agreement to
incorporate the Subject Rights and associated terms. If
LICENSEE’s right of refusal expires unexercised, RESEARCH
FOUNDATION shall have the right to license the Subject Rights to
such third party on the terms set forth in the Subject Notice;
provided that, in the event of any substantive change in such
terms, RESEARCH FOUNDATION shall again provide the Subject Notice
to LICENSEE and LICENSEE shall again have a right of first refusal
as provided herein. LICENSEE shall, notwithstanding the periods
provided in this Paragraph 2.1(b), use good faith efforts to
respond to the Subject Notice (whether the initial Subject Notice
or a subsequent Subject Notice following a substantive change in
terms) as promptly as reasonably practicable within the applicable
period.
(c) RESEARCH FOUNDATION: (i) shall,
within thirty (30) days of the identification of each Option
Invention, report such Option Invention to LICENSEE, together with
any patent disclosures and any supporting technical
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data or other information it
possesses that may be relevant to understanding the value or
commercial significance of such Option Invention; and (ii) hereby
grants to LICENSEE a first option to negotiate an exclusive,
worldwide, royalty-bearing commercially reasonable license (with
the right to sublicense) to RESEARCH FOUNDATION’s rights in
each Option Invention for any purpose. LICENSEE may exercise any
such option by providing written notice to RESEARCH FOUNDATION
within sixty (60) days of its receipt of the notice of the
applicable Option Invention. Upon exercise of the Option, the
parties shall negotiate in good faith the terms of such license
based on [********] .
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2.2
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RESEARCH
FOUNDATION reserves to the University the right to practice under
the Patent Rights solely for the University’s internal
research and education purposes; provided that the foregoing rights
shall be expressly subject to RESEARCH FOUNDATION’s
obligations pursuant to Paragraph 15.
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2.3
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Notwithstanding
anything herein to the contrary, in no event shall either RESEARCH
FOUNDATION or University perform research sponsored by, or for the
benefit of, a third party for-profit entity where such research, if
performed by such third party for-profit entity, would infringe or
would be reasonably likely to infringe the Patent Rights licensed
to LICENSEE hereunder.
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2.4
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The license
granted hereunder shall not be construed to confer any rights upon
LICENSEE by implication, estoppel or otherwise as to any technology
except as specifically set forth herein.
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2.5
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LICENSEE may
grant exclusive or nonexclusive sublicenses to third-party
sublicensees with respect to all or any portion of the license
granted to LICENSEE hereunder only with the approval of RESEARCH
FOUNDATION, which shall: (i) be given unless RESEARCH FOUNDATION
reasonably believes in good faith that the proposed sublicense will
result in LICENSEE’s inability to fulfill its obligations
hereunder; (ii) otherwise not be unreasonably withheld or delayed;
and (iii) be deemed given unless written notice to the contrary is
received by LICENSEE within thirty (30) days after written notice
requesting approval is received by RESEARCH FOUNDATION. RESEARCH
FOUNDATION shall, notwithstanding the period provided in this
Paragraph 2.4, use good faith efforts to respond to
LICENSEE’S written notice as promptly as reasonably
practicable within such period.
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2.6
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LICENSEE agrees
to forward to RESEARCH FOUNDATION a copy of any and all fully
executed sublicense agreements contemplated by Paragraph 2.4. At
the request of RESEARCH FOUNDATION, LICENSEE shall also provide
copies of all distribution agreements and other such agreements
relative to the Licensed Products or involving rights granted to
LICENSEE under the agreement.
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2.7
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Termination of the license
granted to LICENSEE in this Agreement shall terminate all
sublicenses which may have been granted by LICENSEE; provided that
any sublicensee may elect to continue its sublicense by advising
RESEARCH
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FOUNDATION in writing, within
(60) sixty days of the sublicensee’s receipt of written
notice of such termination from RESEARCH FOUNDATION, of its
election and its agreement to assume all of the obligations to
RESEARCH FOUNDATION (including obligations for payment) contained
in this Agreement. Any sublicense granted by LICENSEE shall contain
provisions corresponding to those of this paragraph respecting
termination and the conditions of continuance of
sublicenses.
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2.8
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Except as
otherwise provided in a research or other written agreement between
the parties, each invention, discovery, proprietary development,
data and information, in any medium or manifestation, including any
method, process, composition of matter, apparatus, device, system,
product, article of manufacture or appliance made or developed
after the Effective Date, and all intellectual property rights
relating thereto, shall be owned exclusively by the party making or
developing it, without any accounting, compensation or other
obligation hereunder to the other party.
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ARTICLE III. DUE
DILIGENCE
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3.1
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LICENSEE shall
use commercially reasonable efforts (either alone or through
research collaborations or alliances with research organizations,
pharmaceutical companies or other third parties) to market and
sell, or to develop, one or more Licensed Products or Licensed
Processes through a diligent program for exploitation of the Patent
Rights, and LICENSEE’s failure to use such efforts shall be
grounds for RESEARCH FOUNDATION to terminate this Agreement
pursuant to Paragraph 13.3. Without limiting the generality of the
foregoing, until the NDA Filing Date, LICENSEE shall: (i) spend a
minimum of [********] to conduct research and development of
one or more Licensed Products; provided that, for the avoidance of
doubt, any or all of such amount may [********] ; and (ii)
deliver to RESEARCH FOUNDATION, at least annually, a brief report
summarizing its research and development activities completed since
the last report, research and development activities currently in
process, planned future research and development activities and
research and development work being performed by third parties. If
RESEARCH FOUNDATION believes LICENSEE is failing to comply with its
obligations under this Paragraph 3.1, RESEARCH FOUNDATION may send
notice to the LICENSEE asserting such belief and the basis
therefor. LICENSEE shall have sixty (60) days from its receipt of
such notice either to (i) commence compliance with its obligations
under this Paragraph 3.1 to RESEARCH FOUNDATION’s reasonable
satisfaction or (ii) send notice to RESEARCH FOUNDATION requesting
that such issue be resolved in accordance with Article XII, in
which case the procedures set forth in Article XII shall be
followed.
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3.2
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LICENSEE will use commercially
reasonable efforts to effect the NDA Filing Date on or before
December 31, 2012; provided that the parties acknowledge that (i)
the foregoing target is expressly subject to significant
scientific, clinical and
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regulatory uncertainties and (ii)
failure to meet such target shall not constitute a breach of this
Agreement or entitle RESEARCH FOUNDATION to terminate this
Agreement if SPONSOR is in compliance with Paragraph 3.1, but shall
entitle RESEARCH FOUNDATION, upon sixty (60) days written notice to
LICENSEE, to make the license granted in Paragraph 2.1(a)
nonexclusive.
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3.3
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LICENSEE may,
but expressly without creating any binding obligation, (i) consider
University to conduct or, if applicable, to coordinate particular
pre-clinical or early-stage clinical research in furtherance of
LICENSEE’s diligence obligations hereunder and (ii)
communicate with University researchers from time to time regarding
the research and development of one or more Licensed Products
hereunder.
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ARTICLE IV. FEES AND
ROYALTIES
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4.1
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For the rights,
privileges and license granted hereunder, LICENSEE shall pay to
RESEARCH FOUNDATION:
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(a)
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Milestone
payments payable, if at all, at the times and upon achievement of
the Milestones set forth on Appendix B .
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(b)
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Running
royalties equal to the Applicable Royalty Amount. The
“Applicable Royalty Amount” shall be [********]
of Net Sales of Licensed Products in any country; provided that,
with respect to a particular Licensed Product in a particular
country:
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(i) if (A) [********] or (B)
there exists Competition for such Licensed Product in such country,
the Applicable Royalty Amount shall be reduced to [********]
of Net Sales of such Licensed Product in such country;
and
(ii) if LICENSEE (or a sublicensee)
deems it necessary or advisable to secure a third party license in
order to practice in such country any portion of the license
granted by RESEARCH FOUNDATION hereunder (including, without
limitation, the sale of Licensed Products), the Applicable Royalty
Amount shall be reduced by [********] of the amounts paid to
secure such third party license, but in no event to an amount less
than [********] of Net Sales of Licensed Products in such
country.
Notwithstanding the
foregoing:
(1) the obligations in this
Paragraph 4.1(b) shall expire with respect to Net Sales of a
particular Licensed Product in a particular country on the date of
expiration of the last-to-expire Valid Claim included in the Patent
Rights covering, in whole or in part, such Licensed Product in such
country;
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(2) if Licensed Products are sold or
leased by a sublicensee, LICENSEE shall instead pay to RESEARCH
FOUNDATION the lesser of the amount calculated as provided above in
this Paragraph 4.1(b) or [********] of the running royalties
on the sale or lease of Licensed Products actually received by
LICENSEE from such sublicensee;
(3) the Company’s obligation
to pay royalties under this Paragraph 4.1(b) shall
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