[ * ] = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.
EXHIBIT 10.34
AMENDMENT
This Amendment made and executed as of this 30th day of June, 2006 (hereinafter
referred to as the “Amendment”) constitutes a valid and enforceable amendment to
the Amended and Restated License and Supply Agreement of the 1st day of January,
2005, as amended (hereinafter referred to as the “Agreement”), between Orion
Corporation, a corporation existing under the laws of Finland and having its
principal office at Orionintie 1, 02200 Espoo, Finland (hereinafter referred to
as “Orion”) and GTx Inc., a corporation existing under the laws of the State of
Delaware, U.S.A. and having its principal office at 3 North Dunlap Avenue, Van
Veet Building, Third Floor, Memphis, Tennessee 38163, USA (hereinafter referred
to as “GTX”) (Orion and GTX collectively referred to herein as “Parties”).

     
WHEREAS,
  the Parties have entered into the Agreement on January 1, 2005, as amended;
 
   
WHEREAS,
  the Parties wish to amend the Agreement on the terms and conditions contained
herein in order to agree on prices for European Territory (defined below)
regarding the tablet containing [ * ] Toremifene; and to amend the Agreement on
the terms and conditions with regard to marketing plans and reports of Orion
Products sold in European Territory; and
 
   
WHEREAS,
  the Parties wish that all other terms and conditions of the Agreement shall
remain unchanged and shall be retained in full force and effect unless
specifically agreed otherwise herein;

NOW, THEREFORE, in tending to be legally bound, and in consideration of the
mutual covenants contained herein, the receipt and sufficiency of which are
hereby acknowledged, the Parties hereto agree as follows:

  1.   Unless indicated otherwise in this Amendment, the terms in this Amendment
with initial letters capitalized, whether used in the singular or plural, shall
have the meaning set forth in the Agreement.     2.   Prices for the tablet
containing [ * ] Toremifene in European Territory

“European Territory” shall mean collectively the European Union (“EU”),
Switzerland, Norway, Iceland and Lichtenstein and the Commonwealth of
Independent States (“CIS”). For the avoidance of doubt, the definition of
“European Territory” in the Amendment between the Parties dated as of May 23,
2006 to the Agreement shall also be amended for tablets containing [ * ]
Toremifene to be the same definition as above.
a) Price
Orion’s price of bulk Orion Product to GTX, its Affiliates or its Unaffiliated
Sublicensees for commercial purpose and to be sold, imported, marketed and
distributed solely in European Territory, delivered [ * ] (with the foregoing
being interpreted to effect the [ * ]), shall be:
[ * ] per [ * ] tablet for commercial sale in [ * ]; and
[ * ] per [ * ] tablet for commercial sale in all other European Territory
countries
Nevertheless, the weighted average price per [ * ] tablets sold in European
Territory in any calendar year shall not be less than [ * ] per [ * ] tablet.
For purposes hereof, “weighted average price” shall be calculated as follows: [
* ] per tablet x [all tablets sold in [ * ] which GTX, its
 

[ * ] = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.    

1.

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Affiliates and Unaffiliated Sublicensees believes in good faith, based upon a
reasonable forecast, to be required for the consumption in [ * ] in the calendar
year] + [ * ] per tablet x [all tablets sold in all other European Territory
countries during the calendar year], the sum of which shall be divided by the
total number of tablets sold in the European Territory during the calendar year.
In the event the “weighted average price” of all [ * ] tablets sold in the
European Territory shall be less than [ * ] per tablet for any calendar year,
GTX, its Affiliates or its Unaffiliated Sublicensees shall be required to make
an additional payment for Product supply to Orion within 90 days of the end of
the calendar year in an amount sufficient to allow the weighted average price of
all [ * ] tablets sold during the calendar year to equal [ * ] per tablet.
For the avoidance of a doubt, the Parties understand and agree that Orion is
bound to the aforementioned prices only to the extent that specifications,
analyses and stability requirements are the same than for the tablets
manufactured for the USA markets.
b) Sample Prices
Orion’s price of bulk Orion Product to GTX, its Affiliates or its Unaffiliated
Sublicensees for samples, including clinical trial samples, used solely in
European Territory, delivered [ * ] (with the foregoing being interpreted to
effect [ * ]), shall be:
[ * ] per [ * ] tablet for European Territory
For the avoidance of a doubt, the Parties understand and agree that Orion is
bound to the aforementioned prices only to the extent that specifications,
analyses and stability requirements are the same than for the tablets
manufactured for the USA markets.

  3.   Marketing Plan and Reports. Without prejudice to Section 6.6 of the
Agreement, the Parties agree on the terms with respect to European Territory
countries as follows:

Marketing Plans. GTX shall develop and provide to Orion by October 31 of each
year during the Term marketing and sales plans for the Product for all European
Territory countries for the following calendar year, commencing with the
calendar year in which Regulatory Approval is obtained in each respective
European Territory country. Such plans shall include the projected Annual Net
Sales.
Sales Reports for Product. GTX shall provide to Orion, within forty-five
(45) days after the end of each calendar year, a written sales report for each
of the European Territory countries in which Product is launched.

  4.   This Amendment shall become effective on June 30, 2006.     5.   Except
as specifically set forth and/or amended herein, all the terms and conditions of
the Agreement shall remain unchanged.

 

[ * ] = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.    

2.

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IN WITNESS WHEREOF,
the Parties, through their authorized representatives, have executed two (2)
identical copies of this Amendment.

                          Orion Corporation
ORION PHARMA       GTx Inc.
 
                   
 
  By: /s/ Timo Lappalainen       By: /s/ Henry P. Doggrell
 
 
 
     
 
 
  Name: Timo Lappalainen       Name: Henry P. Doggrell
 
  Title: Senior Vice President       Title: VP, General Counsel
 
                   
 
  By: /s/ Matti Vaheri            
 
 
 
           
 
  Name: Matti Vaheri            
 
  Title: Director, Global Alliance Management            

 

[ * ] = 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 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS
AMENDED.    

3.