AMENDED AND RESTATED LICENSE
AGREEMENT
This First Amendment to Amended and
Restated License Agreement (the
“Amendment”) is entered into as of
December 29, 2008 (the “Amendment
Date”) by and between GTx, Inc. , a Delaware
corporation, located at 3 N. Dunlap Street, Memphis, Tennessee
38163 (“ GTx ”), and University of Tennessee Research
Foundation , a Tennessee corporation, having an office
at UT Conference Center, Suite 211, 600 Henley Street,
Knoxville, Tennessee 37996-4122 (“UTRF”), for the
purpose of amending that certain Amended and Restated License
Agreement, dated September 24, 2007, between GTx and UTRF (the
“Original Agreement” and, collectively
with this Amendment, the
“Agreement”).
Capitalized
terms used but not defined herein shall have the respective
meanings ascribed to such terms in the Original
Agreement.
Whereas , the Parties desire
to amend the Original Agreement to clarify GTx’s payment
obligations to UTRF for consideration received by GTx from its
Sublicensees.
Now, Therefore , in
consideration of the foregoing and the covenants and promises
contained in this Amendment and other good and valuable
consideration, the Parties agree as follows:
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1.
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Amendment of “Sublicense
Revenue” Definition. Section 1.36 of the Original
Agreement is hereby amended and restated to read in its entirety as
follows:
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“1.36 “ Sublicense
Revenue ” shall mean all payments actually received by
GTx pursuant to and in connection with each Sublicense, including,
without limitation, up-front license fees, milestone payments,
license maintenance fees, election fees, and all other fees and
payments received by GTx under each Sublicense agreement, subject
to the following:
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A.
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Deductions . There shall be deducted from
Sublicense Revenue payments received by GTx as reimbursement for
actual, otherwise unreimbursed, out-of-pocket expenses as set out
in the applicable Sublicense agreement, provided that only
reimbursements for expenses incurred in the development of one or
more Licensed Products covered by such Sublicense agreement may be
deducted from Sublicense Revenue and then only to the extent of
expenses incurred from and after the date of the Sublicense
agreement for pre-clinical or clinical research and development,
including development of the formulation and manufacturing process,
manufacturing of preclinical and clinical supplies and analytical
and stability testing as required by the Food and Drug
Administration to support a New Drug Application filing for the
Licensed Product. However, no part of any reimbursement received by
GTx from Ipsen for actual out-of-pocket pre-clinical and clinical
research and development expenses incurred by GTx for the PIN
Indication (as defined in the Ipsen Sublicense) will be considered
Sublicense Revenue, although the amount of any premium on
Ipsen’s share of Past Initial Development Expenses (as
defined in the Ipsen Sublicense) for the PIN Indication paid to GTx
by Ipsen under subsection (ii) of Section 4.2(e)(iii) of
the Ipsen Sublicense will be considered Sublicense Revenue.
Additionally, Sublicense Revenue will not include any payments made
to Third Parties by or on behalf of a Sublicensee for conducting
clinical trials, filing new drug applications, commercially
launching a product and/or
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marketing and
selling a product, since these are not payments received by GTx
from a Sublicensee on account of the Sublicense.
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B.
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Exclusions . Sublicense Revenue will not
include:
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(a)
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running royalties received by GTx
that are calculated as a percentage of Sublicensee’s Net
Sales;
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(b)
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consideration paid to GTx in
exchange for securities of GTx up to the “fair market
value” (as hereinafter defined) of such
securities;
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(c)
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any
milestone payment received by GTx from Ipsen on account of
Regulatory Approval (as defined in the Ipsen Sublicense) being
obtained in a Major Country (as defined in the Ipsen Sublicense)
for a diagnostic test for the PIN Indication or prostate cancer, as
provided in Section 3.2 (8) of the Ipsen Sublicense;
and
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(d)
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in
the event the Sublicense of Licensed Subject Matter is granted in
conjunction with a license of distinct GTx technology that is not
Licensed Subject Matter (“Other
Technology”), amounts allocable to such Other
Technology as reasonably established by GTx and the Sublicensee and
set out in the Sublicense agreement; provided that if no such
allocation is made in the Sublicense agreement, then the prorated
portion of any fees or payments (not otherwise excluded or deducted
pursuant to this Section 1.36) made to GTx under such
Sublicense agreement in consideration for such Other Technology
shall be excluded.
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For
purposes of this Section 1.36 (B), “fair market
value” shall mean (1) with respect to the Common Stock
of GTx, the closing price of the Common Stock as quoted or traded
on the NASDAQ Global Market (or other applicable exchange or public
market) on the day of closing of such stock sale, or if the closing
of such stock sale does not take place on a trading day, the
closing price on the last trading day prior to the day of closing
of such stock sale; and (2) with respect to any other security
of GTx other than Common Stock, the parties shall seek in good
faith to agree on the fair market value of such security and in the
event the parties cannot mutually agree on such value, the
determination of fair market value shall be submitted to dispute
resolution pursuant to Section 11.1. Also for clarity, in the
case of the purchase of securities of GTx by a Sublicensee or an
Affiliate of Sublicensee, (i) if such securities are acquired
in connection with the receipt of rights under Licensed Subject
Matter, then any amounts paid in excess of the fair market value of
such securities shall be included as an element of Sublicense
Revenue, (ii) if such securities are acquired by a Sublicensee
in a transaction not in connection with the grant of rights (or the
grant of further rights) under Licensed Subject Matter, then no
portion of the purchase price of such securities shall constitute
Sublicense Revenue, regardless of the relationship between purchase
price and fair market value, and (iii) if GTx were to be
acquired by a Sublicensee or an Affiliate of a Sublicensee, no
portion of the purchase price in any form shall be Sublicense
Revenue.
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2. Amendment
to Dispute Resolution. Section 11.1 of the Original
Agreement is hereby amended and restated to read in its entirety as
follows:
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“11.1 Except for the right of
either party to apply to a court of
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