AMENDMENT
[ * ] = 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 Xxxxxxxxxx 0, 00000 Xxxxx, Xxxxxxx (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 Xxxxxx Avenue, Van Veet Building, Third
Floor, Memphis, Xxxxxxxxx 00000, XXX (hereinafter referred to as “GTX”) (Orion and GTX collectively
referred to herein as “Parties”).
WHEREAS,
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the Parties have entered into the Agreement on January 1, 2005, as amended; | |
WHEREAS,
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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,
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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 Xxxxxxxxxxxx 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.
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.
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/ Xxxx Xxxxxxxxxxx | By: /s/ Xxxxx X. Xxxxxxxx | |||||||||
| Name: Xxxx Xxxxxxxxxxx | Name: Xxxxx X. Xxxxxxxx | |||||||||
| Title: Senior Vice President | Title: VP, General Counsel | |||||||||
| By: /s/ Xxxxx Xxxxxx | ||||||||||
| Name: Xxxxx Xxxxxx | ||||||||||
| 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.
