[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
EXHIBIT 10.16
AMENDMENT
This Amendment made and executed as of this 5th day of March 2003 ("effective
date") constitutes a valid and enforceable amendment to the Amended and Restated
Toremifene License and Supply Agreement of the 22nd day of October 2001
(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 organized and existing under the laws of the State of
Tennessee, U.S.A. and having its principal office at 3 North Xxxxxx Avenue, Van
Vleet Building, Third Floor, Memphis, Tennessee 38163, U.S.A. (hereinafter
referred to as "GTx") (ORION and GTx collectively referred to herein as
"Parties").
WHEREAS, the Parties have entered into the Agreement on October 22, 2001;
WHEREAS, the Parties wish to amend the Agreement on the terms and conditions
contained herein; 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, the Parties hereto agree as follows:
The Parties have agreed to amend the Section 1.35 of the Agreement to read in
its entirety as follows:
"Toremifene" shall mean [ * ].
The Parties have agreed to amend the Section "Definitions" by adding a new
section 1.42:
"SERM" shall mean [ * ] as described in the Orion Patent Rights including its
isomers, metabolites, derivatives and analogs, having either antiestrogenic or
estrogenic pharmacological properties.
The parties have agreed that the phrase "...anti-estrogen and/or SERM..." as
used in the Agreement shall hereby be amended to delete tHe reference to
"anti-estrogen" and to limit the applicable sentence to only SERMs. By way of
explanation, the definitions for "Competing Product" (Section 1.4), "GTX
Know-How" (Section 1.10), "GTX Patents" (Section 1.11) and "GTX Patent
Applications" (Section 1.12), are all hereby amended to delete the reference
therein to "anti-estrogen" and to limit the definition to SERM as set forth in
the applicable definition.
The Parties have agreed to amend the Section 1.6 of the Agreement to read in its
entirety as follows:
"Field" shall mean the prevention and treatment of prostate cancer,
which shall mean for the purposes of hereof: preventing prostate
carcinogenesis; suppressing or inhibiting prostate cancer; reducing the
risk of developing prostate cancer; increasing the survival rate of a
subject with prostate cancer; and treating prostate cancer.
Furthermore, the Field shall include the prevention and/or treatment of
osteoporosis, gynecomastia, and hot flashes, induced by chemical or
surgical androgen deprivation therapy in the treatment of prostate
cancer.
In consideration of the expansions of the definition of Field, and, as a
consequence, GTx' rights under the Agreement, the Parties have agreed to:
(I) amend section 2.1.5(a) of the Agreement to read in its entirety as follows:
(a) Orion grants GTX, on a country by country
basis, the right of first negotiation to negotiate further agreements
under commercially reasonable terms and conditions regarding the
further development, registration, promotion, marketing, sales and
distribution of a pharmaceutical product for human use within the Field
containing SERMs, as the active ingredient (a) which is covered by a
Valid Claim within the GTX Patent Rights in such country; and (b) for
which Orion has both a license or other right to develop and
commercialize such products and within five (5) years after the
Amendment Date, Orion has commenced Phase I clinical trials for such
product anywhere in the world for a primary indication falling within
the Field (a product fulfilling (a) and (b), hereinafter referred to as
"Additional Product"). [ * ] after GTX's receipt in writing of a first
offer from Orion regarding commercially reasonable terms and conditions
for obtaining rights in and to such Additional Product, GTX shall
notify Orion in writing if it wishes to enter into negotiations with
respect to such Additional Product. Should GTX elect to exercise such
right, the Parties agree to negotiate in good faith the commercially
reasonable terms and conditions for a letter of intent to be completed
[ * ] of receipt by Orion of such notification from GTX. Any deadlines
may be extended by mutual written agreement. Should GTX fail to provide
written notification to Orion by the end of [ * ], or GTX notifies
Orion that it does not wish to enter into negotiations; or the Parties,
despite conducting good faith negotiations, are unable to finalize the
commercial terms of the letter of intent [ * ], GTX shall have no
further rights in the SERM, and Orion shall be free to contract with a
Third Party concerning same or itself further pursue the development,
registration, promotion, marketing, sales and distribution of such
Additional Product.
(II) amend section 2.1.5(b) of the Agreement to read as follows:
(b) During the term of any Orion Patents or the
pendency of any Orion Patent Application in the relevant country, Orion
grants GTX, on a country by country basis as set forth in this Section
2.1.5(b), a right of first negotiation to negotiate with Orion an
agreement under which GTX would, on commercially reasonable terms and
conditions, develop, register, promote, market, sell and distribute
"Interchangeable Pharmaceutical Products Containing Toremifene" for use
outside the Field ("Other Activities"), provided, however, that such
right of first negotiation described in this Section 2.1.5(b) shall not
extend to breast cancer indications. For purposes hereof,
"Interchangeable Pharmaceutical Products Containing Toremifene" shall
mean any pharmaceutical product containing Toremifene for use in humans
which is sufficiently similar with any Product of GTx (for which at
least a Phase II clinical trial has been commenced for such Product
anywhere in the world) to be considered therapeutically equivalent
("Other Toremifene Product"), which equivalence reasonably may result
in, or materially increase the likelihood for substitution by a health
care provider of such Product of GTx for the Other Toremifene Product.
All other terms and conditions of the Agreement shall remain unchanged.
IN WITNESS WHEREOF, the Parties, through their authorized representatives, have
executed two (2) identical copies of this Amendment as of the effective date.
Orion Corporation GTx, Inc.
By: /s/ Xxxx Xxxxxxxxxxx By: /s/ Xxxxx X. Xxxxxxxx
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Name: Xxxx Xxxxxxxxxxx Name: Xxxxx X. Xxxxxxxx
-------------------------------- -----------------
Title: Executive Vice President Title: General Counsel / Secretary
------------------------------- ---------------------------
By: /s/ M. Vahari
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Name: Matti Vahari
------------
Title: Senior Vice President
---------------------
[ * ] = 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 406 OF THE SECURITIES ACT OF 1933, AS AMENDED.
