Exhibit 10.48
FIRST AMENDMENT TO
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.
RECITALS
     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:

1.   Amendment of “Sublicense Revenue” Definition. Section 1.36 of the Original
Agreement is hereby amended and restated to read in its entirety as follows:

    “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:

  A.   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.     B.   Exclusions.
Sublicense Revenue will not include:

  (a)   running royalties received by GTx that are calculated as a percentage of
Sublicensee’s Net Sales;     (b)   consideration paid to GTx in exchange for
securities of GTx up to the “fair market value” (as hereinafter defined) of such
securities;     (c)   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     (d)   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.

      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.

2. Amendment to Dispute Resolution. Section 11.1 of the Original Agreement is
hereby amended and restated to read in its entirety as follows:

    “11.1 Except for the right of either party to apply to a court of competent
jurisdiction for a

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    temporary restraining order, a preliminary injunction, or other equitable
relief to preserve the status quo or to prevent irreparable harm, any and all
claims, disputes or controversies arising under, out of, or in connection with
this Agreement, including without limitation any dispute with respect to the
scope of this Section 11, shall be resolved upon thirty (30) days written notice
of either party to the other by final and binding arbitration in Knoxville,
Tennessee (or other site acceptable to both Parties) under the Commercial
Arbitration Rules of the American Arbitration Association, or the Patent
Arbitration Rules if applicable, then in effect. The arbitrator(s) shall have no
power to add to, subtract from or modify any of the terms or conditions of this
Agreement, nor to award punitive damages. The prevailing party in any such
arbitration shall, in addition to recovering reasonable out-of-pocket costs of
the arbitration, be entitled to an award of reasonable attorneys fees incurred
in connection with the arbitration and any action necessary to perfect the
arbitration award as a judgment, and for any collection action required to
secure payment of any arbitration award. Any award rendered in such arbitration
may be entered and enforced by either party in either the courts of the State of
Tennessee or in the United States District Court for the Eastern District of
Tennessee, to whose jurisdiction for such purposes UTRF and GTx each hereby
irrevocably consents and submits, or in any other United States court having
jurisdiction.”

3.   Amendment to Assignability. Section 13.1 of the Original Agreement is
hereby amended and restated to read in its entirety as follows:       “13.1 This
Agreement shall be binding upon and shall inure to the benefit of UTRF and its
assigns and successors, and shall be binding upon and shall inure to the benefit
of GTx and its assigns provided that prior written approval by UTRF is first
obtained, which approval shall not be unreasonably withheld. Notwithstanding the
foregoing, no prior written approval from UTRF shall be required for any
assignment by GTx to (i) an Affiliate of GTx (or any entity into which GTx shall
have been merged or consolidated, provided that at least 51% of such merged or
consolidated entity is owed by shareholders holding at least 51% of GTx
immediately prior to such merger or consolidation) or (ii) a Third Party which
acquires all or substantially all of GTx’s assets or a Controlling interest in
the business to which this Agreement relates if, but only if, the Third Party
can reasonably demonstrate prior to such transaction, either: (I) a financial
net worth or market cap equal to or better than the financial net worth of GTx
existing prior to the acquisition, but not less than a net worth of One Hundred
Million Dollars ($100,000,000); or (II) a market cap of Five Hundred Million
Dollars ($500,000,000). No assignment shall be deemed effective unless such
assignee has agreed in writing to be bound by the terms and provisions of this
Agreement. Any attempt to assign or assignment made in violation of this
Section 13.1 shall be void ab initio. GTx shall give notice to UTRF of any
assignment of this Agreement within thirty (30) days thereafter, such notice to
include a copy of assignee’s written agreement to be bound by the terms and
provisions of this Agreement. For the avoidance of doubt, any consideration
received by GTx from a permitted assignee in consideration of an assignment
pursuant to this Section 13.1 shall not be deemed Sublicense Revenue.”   4.  
Clarification of the Treatment of Other Payments Under The Ipsen Sublicense. For
the avoidance of doubt, the Parties desire to confirm the treatment of payments
received to date and which may be received in the future under the Ipsen
Sublicense, as follows:

  (a)   Election Fee. Any payment received by GTx from Ipsen pursuant to Section
3.1(c) of the Ipsen Sublicense shall be treated as Sublicense Revenue under the
Agreement.     (b)   Milestone Events. Any payment received by GTx from Ipsen
pursuant to

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      Section 3.2 of the Ipsen Sublicense for Milestone Events numbered 1, 4 or
6 shall not be treated as Sublicense Revenue under the Agreement to the extent
such payments are made with respect to the ADT Indication (as defined in the
Ipsen Sublicense) and any payment received by GTx from Ipsen for Milestone
Events numbered 2, 3 and 5 shall be treated as Sublicense Revenue under the
Agreement to the extent such payments are made with respect to the PIN
Indication. Any payment received by GTx from Ipsen pursuant to Milestone Event
number 7 will be considered Sublicense Revenue if, but only if and to the extent
that, the required milestone payment is paid on account of a Licensed Product
for the PIN Indication, and if and only if and to the extent that payments are
made under such Milestone Event on account of a Licensed Product for the ADT
indication, then such payment shall not be Sublicense Revenue.

  (c)   Royalty Payments Under Ipsen Sublicense.

  1.   UTRF shall be paid Running Royalties on Ipsen’s receipts from sales of
Licensed Product (as defined in the Ipsen Sublicense) solely to the extent such
payments are made with respect to the PIN Indication.     2.   For purposes of
calculating Running Royalties on Net Sales pursuant to Section 4.1B. of the
Agreement, all deferrals pursuant to Section 3.9 of the Ipsen Sublicense of
Royalty Payments (as defined in the Ipsen Sublicense) on Ipsen’s Net Sales with
respect to the PIN Indication shall result in the deferral of Running Royalties
to be paid to UTRF by GTx or its Sublicensee, Ipsen, on the same Net Sales of
Ipsen until such deferred payment is made by Ipsen in accordance with the terms
of Section 3.9 of the Ipsen Sublicense, at which time both the Running
Royalties, and any interest attributable thereto (paid pursuant to Section 3.9
of the Ipsen Sublicense), shall be paid to UTRF by GTx or Ipsen.     3.   Any
interest payments received by GTx from Ipsen pursuant to Section 3.7 of the
Ipsen Sublicense shall not be treated as Sublicense Revenue or Running Royalty
under the Agreement.

  (d)   Sales by Sublicensees of Ipsen. Any payment received by GTx from Ipsen
pursuant to Section 3.5 of the Ipsen Sublicense as royalties on Net Sales of
Licensed Products by Ipsen’s Sublicensees shall not be treated as Sublicense
Revenue under the Agreement to the extent such payment is calculated as a
percentage of such Sublicensees’ Net Sales.     (e)   Initial Development
Expenses. Any payment received by GTx from Ipsen pursuant to Section 4.2(f)(iii)
shall not be treated as Sublicense Revenue under the Agreement.     (f)  
Calculation of the Opt-in Payment. Any payment received by GTx from Ipsen
pursuant to Section 4.3(c)(iii)(3) of the Ipsen Sublicense shall not be treated
as Sublicense Revenue under the Agreement.     (g)   Intellectual Property. Any
payment received by GTx from Ipsen pursuant to Article 9 of the Ipsen Sublicense
for shared costs and expenses of patent prosecution, maintenance, enforcement
and defense shall not be treated as Sublicense Revenue under the Agreement,
provided that such costs and expenses are incurred after the Effective Date of
the Ipsen Sublicense.     (h)   Effect of Termination. The treatment of any
payments received by GTx from Ipsen pursuant to Ipsen’s continuing payment
obligations under Article 12 of the Ipsen

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      Sublicense shall be based on whether or not such payments would have
constituted Sublicense Revenue if they had been paid prior to the date of
termination of the Ipsen Sublicense.     (i)   Indemnification. Any payment
received by GTx from Ipsen pursuant to Article 13 of the Ipsen Sublicense shall
not be treated as Sublicense Revenue under the Agreement.     (j)   Up-Front
Fees. The up-front fee GTx has already received from Ipsen in October 2006 upon
its entering into the Ipsen Sublicense and the up-front fee payment received
from Ipsen in 2007 and 2008 and the up front fee payment it will receive in 2009
pursuant to the Ipsen Sublicense shall not be considered Sublicense Revenue.

5.   Governing Law; Jurisdiction. This Amendment shall be governed by and
construed in accordance with the laws of Tennessee, without regard to conflicts
of laws provisions.   6.   Entire Agreement. This Amendment and the Original
Agreement (except to the extent expressly amended by this Amendment)
collectively embody the entire, final and complete agreement and understanding
between the parties and replace and supersede all prior discussions and
agreements between the parties with respect to the subject matter hereof or
thereof. The Agreement, as hereby amended, remains in full force and effect.  
7.   Counterparts. This Amendment may be executed in two counterparts (which may
be delivered by facsimile or PDF), each of which shall be an original and both
of which together shall constitute the same document.

          In Witness Whereof, the Parties hereto have duly executed this
Amendment as of the Amendment Date.

              GTx, Inc.   University of Tennessee Research Foundation
 
           
By:
  /s/ Henry P. Doggrell   By:   /s/ Fred D. Tompkins
 
           
Name:
  Henry P. Doggrell   Name:   Fred D. Tompkins
 
           
Title:
  VP, General Counsel   Title:   President
 
           

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