Back to top

FIRST AMENDMENT TO AMENDED AND RESTATED LICENSE AGREEMENT

License Agreement

FIRST AMENDMENT TO AMENDED AND RESTATED LICENSE AGREEMENT | Document Parties: GTX, INC You are currently viewing:
This License Agreement involves

GTX, INC

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: FIRST AMENDMENT TO AMENDED AND RESTATED LICENSE AGREEMENT
Date: 3/3/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

FIRST AMENDMENT TO AMENDED AND RESTATED LICENSE AGREEMENT, Parties: gtx  inc
50 of the Top 250 law firms use our Products every day

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

 


 

 

 

 

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


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more