FIRST AMENDMENT TO
CONSOLIDATED, AMENDED, AND RESTATED LICENSE
AGREEMENT
This First Amendment to Consolidated,
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
Consolidated, Amended and Restated License Agreement, dated
July 24, 2007, between GTx and UTRF (the “
Original Agreement ” ).
Capitalized terms
used but not defined herein shall have the respective meanings
ascribed to such terms in the Original Agreement.
Whereas , GTx has entered into
that certain Exclusive License and Collaboration Agreement with
Merck & Co., Inc., ( “ Merck ” )
dated as of November 5, 2007 (the “ Merck
Sublicense ” ), pursuant to which Merck has become
GTx’s exclusive Sublicensee of certain SARM technology
licensed to GTx under the Original Agreement;
Whereas , a dispute arose
between the Parties with respect to the amount of Sublicense
Royalties payable to UTRF under the Original Agreement on account
of certain payments received by GTx in connection with the Merck
Sublicense; and
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 1.47 of the Original
Agreement is hereby amended and restated to read in its entirety as
follows:
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“1.47 “ 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 such 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,
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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
(“NDA”) filing for the Licensed Product and any NDA
Third Party preparation costs and filing fees. No part of the
research funding payable by Merck to GTx pursuant to
Section 8.1 of the Merck Sublicense as reimbursement for basic
research and medicinal chemistry activities or any other
reimbursements which GTx may receive for activities in support of
Development Programs (as defined in the Merck Sublicense) under
Section 4.5 of the Merck 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 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 payments and royalty payments received by GTx from Merck
under Sections 8.4 and 8.5 of the Merck Sublicense, but only
to the extent such payments are on account of Products (as defined
in the Merck Sublicense) which are not Licensed Products
hereunder;
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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 1.47) made to GTx under such Sublicense agreement
in consideration for such Other Technology shall be excluded;
and
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(e)
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up-front fees received by GTx from
Ortho Biotech Products L.P. pursuant to the Joint Collaboration and
License Agreement entered into with GTx effective as of
March 16, 2004.
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For purposes of
this Section 1.47B., “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
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