Ex-10.15 Amended License & Supply Agreement



 




Exhibit 10.15




 





[ * ] = Certain confidential information contained in this document, marked by brackets,
has been omitted and filed separately with the Securities and Exchange Commission pursuantis
pursuant to Rule 406 of the Securities Act of 1933, as amended.




AMENDED AND RESTATED LICENSE AND SUPPLY AGREEMENT




     This Amended And Restated License And Supply Agreement (this “Agreement”) is
entered into and made effective as of this ___day of October, 2001 (the “Amendment Date”) by
and between Orion Corporation, a corporation organized and existing under the laws of
Finland and having its principal office at Orionintie 1 FIN-02200 Espoo, Finland (“Orion”), and GTx
Inc., (fka Genotherapeutics, 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 Dunlap Avenue, Van Vleet
Building, Third Floor, Memphis, Tennessee 38163, USA (“GTX”).



     Whereas, Orion and GTX entered into a Toremifene License and Supply Agreement
effective as of March 30, 2000 (the “Effective Date”), to govern the Parties’ rights and
obligations with respect to the research, development, commercialization and manufacture of Product
(as defined in said agreement) (the “Original Agreement”);



     Whereas, the Parties desire with this Agreement to supercede the Original Agreement
as of the Amendment Date to provide that GTX shall have the sole responsibility for researching,
developing, registering and commercializing the Product (as defined below) within the Field (as
defined below) worldwide, and that Orion shall have no monetary or other responsibilities for
researching, developing, registering and commercializing Product, but shall remain responsible for
manufacturing Orion Product (as defined below), as agreed herein;



     Now Therefore for and in consideration of the mutual covenants contained herein, the
receipt and sufficiency of which are hereby acknowledged, Orion and GTX (hereinafter individually a
“Party”; and collectively the “Parties”) hereto agree as follows:



1. DEFINITIONS




     For purposes of this Agreement, the following terms shall be defined as set forth below.
Additional terms used in specific Sections of this Agreement shall be defined in such Sections.



     1.1 “Affiliate” shall mean any business entity controlled by a Party, or which controls a
Party, or which is under common control with a Party. “Control” herein means the direct or indirect
ownership of more than fifty percent (50%) of the authorized issued voting shares in such entity,
or such other relationship as in fact legally results in effective control over the management,
business and affairs of such entity or Party, as the case may be.



     1.2 “Annual Net Sales” shall mean Net Sales (as defined below) in any calendar year.





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has
 been omitted and filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities Act of 1933,
as amended.




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     1.3 “Calendar Quarter” shall mean each of the three (3) month periods beginning on January 1,
April 1, July I and October 1 of each year during the Term (as defined below).



     1.4 “Competing Product” shall mean any pharmaceutical product containing an anti-estrogen
and/or a SERM as a therapeutically active ingredient as well as any salt thereof, which product is
licensed, sold and/or marketed for use in the Field, including, but not limited to, other dosage
forms licensed, sold and/or marketed for use in the same Field as the Product. Competing Product
does not include Orion Product, its Affiliate or subcontractor, but includes any generic form of
the Product.



     1.5 “DMF” shall have the meaning provided in Section 7.4.



     1.6 “Field” shall mean the prevention and treatment of prostate cancer, which shall mean for
purposes 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.



     1.7 “First Commercial Sale” means in each country, the date the Product is first sold,
marketed, or publicly made available for sale for use in the Field by GTX, its Affiliate or a GTX
Unaffiliated Sublicensee. Product for use in the Field, distributed or used for clinical trial
purposes shall not be considered sold, marketed or made publicly available for sale and shall not
constitute First Commercial Sale.



     1.8 “Generic Product” shall mean a generic pharmaceutical product for human use containing
Toremifene as an active ingredient and which can be substituted by the prescriber or dispenser for
a Product for use in the Field.



     1.9 “GTX Final Development and Registration Plan” shall mean the final product development and
registration plan for each Product in the Field prepared by GTX, its Affiliate or a GTX
Unaffiliated Sublicensee, as the same may be modified from time to time pursuant to Section 7.3.



     1.10 “GTX Know-How” shall mean such non-patented and unpublished non-clinical, pre-clinical
and clinical documentation, information, and data including information and data in the US IND [ * ] relating to the use of any anti-estrogen and/or SERM in the Field, that is owned or controlled
by, and disclosable by and available to, GTX and its Affiliates as of the Effective Date or at any
time during the Term, including but not limited to all registration materials for the Product
developed, acquired or compiled by GTX and/or its Affiliates as of the Effective Date or at any
time during the Term, and all non-patented and unpublished documentation, information and data
relating to the formulation, manufacture and/or quality control of the Product that is owned or
controlled by GTX and/or its Affiliates as of the Effective Date or at any time during the Term.



     1.11 “GTX Patents” shall mean the patents issued from GTX Patent Applications as of the
Effective Date and other patents owned or controlled by GTX and its Affiliates that are issued at
any time during the Term and that relate to the manufacture, sale or
use of any anti-estrogen and/or SERM for use in the Field (including any divisions,
continuations, continuations-



 




			
	[ * ] = 	 	 Certain confidential information contained in this document, marked by brackets, has
 been omitted and filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





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in-part, re-examinations, reissues, additions, renewals and extensions
thereof). GTX Patents in existence as of the Effective Date are set forth in Part I of Schedule A.



     1.12 “GTX Patent Applications” shall mean patent applications of GTX and/or its Affiliates
pending as of the Effective Date and patent applications owned or controlled by GTX and/or its
Affiliates that are filed at any time during the Term, in each case that relate to the manufacture,
sale or use of any anti-estrogen and/or SERM for use in the Field (including any divisions,
continuations, continuations-in-part, re-examinations, reissues, additions, renewals and extensions
thereof). GTX Patent Applications in existence as of the Effective Date are set forth in Part II of
Schedule A. For purposes of this Agreement, the Parties acknowledge that GTX Patent Applications
shall include patent application U.S. Serial No. [ * ] which claims the use of Product in the
Field, which application is in the name of and owned by The University of Tennessee Research
Corporation. GTX represents and warrants that it has acquired sufficient rights and licenses from
The University of Tennessee Research Corporation to said application for the purpose of performing
its obligations under this Agreement.



     1.13 “GTX Patent Rights” shall mean GTX Patents and GTX Patent Applications.



     1.14 “GTX Preliminary Development and Registration Plan” shall mean the preliminary product
development plan for the development of the Product in the Field prepared by GTX which has been
provided to Orion prior to Effective Date, and which was attached to the Original Agreement.



     1.15 “GTX Territory” shall mean all countries or territories worldwide.



     1.16 “GTX Unaffiliated Sublicensee” shall mean any sublicensee of GTX other than a GTX
Affiliate. For avoidance of doubt, Orion shall not be a GTX Unaffiliated Sublicensee.



     1.17 “Major Country” shall mean the United States of America including its fifty states, the
District of Columbia, Puerto Rico, and all other USA territories and possessions (“USA”), Canada,
Japan, Great Britain, France, Germany, Spain and Italy.



     1.18 “Manufacturing Patents” shall have the meaning provided in Section 7.6.



     1.19 “Net Sales” shall mean the invoiced gross sales of the Product to a Third Party which is
not a GTX Unaffiliated Sublicensee, less: (A) credits and allowances or adjustments (consistent
with generally accepted accounting principles), granted to such customers on account of rejections,
recalls or returns of the Product previously sold; (B) any customary and reasonable trade and cash
discounts, rebates, including government rebates, granted in connection with sale of Product to
such customers; (C) sales, tariff duties and/or use taxes directly imposed and with reference to
particular sales; and (D) outbound transportation prepaid or allowed, amounts allowed or credited
on returns, export licenses, import duties, value added tax, and prepaid freight.



     1.20 “North American Territory” shall mean (i) the USA (ii) Mexico, and (iii) Canada.




 




			
	[ * ] = 	 	 Certain confidential information contained in this document, marked by brackets, has
been omitted and filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





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     1.21 “Orion Know-How” shall mean such non-patented and unpublished non-clinical, pre-clinical
and clinical documentation, information, and data relating to the Orion Product that is owned or
controlled by, and disclosable by and available to, Orion and its Affiliates as of the Effective
Date or at any time during the Term which is necessary for the development by GTX of Product for
use in the Field (including without limitation filing an application for Regulatory Approval for
the Product for use in the Field), including information and data in U.S. NDA [ * ] relating to
the Orion Product, registration materials for the Orion Product, documentation, information and
data relating to the formulation and/or quality control of the Orion Product. Except as otherwise
provided in Sections 7.6, 13.9, 15.1, 16.3.2, 16.4 and 20.2, Orion Know-How shall exclude
information relating to Orion’s manufacture of Toremifene (as defined below) and Orion Product (as
defined below).



     1.22 “Orion Patents” shall mean the patents owned or controlled by Orion that are directed to
the compound Toremifene per se, and relate to the use or sale of Toremifene and all other patents
issued from Orion Patent Applications during the Term (including any divisions, continuations,
continuations-in-part, re-examinations, reissues, additions, renewals and extensions thereof).
Orion Patents in existence as of the Effective Date are set forth in Part I of Schedule B. Schedule
B shall be amended by Orion from time to time during the Term to include future Orion Patents.



     1.23 “Orion Patent Applications” shall mean patent applications owned or controlled by Orion
and its Affiliates that are pending as of the Effective Date, and patent applications owned or
controlled by Orion and its Affiliates that are filed at any time during the Term, in each case
that are directed to the compound Toremifene per se and relate to the use or sale of Toremifene
(including any divisions, continuations, continuations-in-part, re-examinations, reissues,
additions, renewals and extensions thereof). Orion Patent Applications in existence as of the
Amendment Date are set forth in Part II of Schedule C. Schedule C shall be amended by Orion from
time to time during the Term to include future Orion Patent Applications.



     1.24 “Orion Patent Rights” shall mean Orion Patents and Orion Patent Applications.



     1.25 “Orion Product” shall mean tablets containing [ * ] of Toremifene respectively, that are
manufactured by Orion and are commercially available as of the Amendment Date, and such other
dosage strength or formulation of Toremifene as a therapeutically active ingredient as Orion may
agree to manufacture pursuant to Section 16.4.



     1.26 “Orion Unaffiliated Sublicensee” shall mean any licensee or sublicensee under the Orion
Patent Rights, other than an Orion Affiliate, GTX, a GTX Affiliate or a GTX Unaffiliated
Sublicensee.



     1.27 “Premium” shall mean, with respect to an equity investment by a Third Party in GTX, an
amount equal to the difference between the total consideration paid for the
purchase of shares of GTX stock and the fair market value of such stock, as defined herein.
Such fair market value shall be equal to either (i) if GTX has not had an initial public offering
of its stock prior to the date of such investment by such Third Party, and does not conduct such a
public offering concurrently with such investment, the average price per share of GTX stock offered
in GTX’s two (2) most recent rounds of equity financing, multiplied by the number of shares of GTX
stock




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




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issued to such Third Party investor, also on an as-warranted basis, or (ii) if GTX has had an
initial public offering of its stock prior to the date of such investment by such Third Party, or
is then conducting such a public offering concurrently with such Third Party investment, the
trading price of a share of GTX common stock on the date such Third Party investment is made (or,
if such date is not a trading day, the price of a share of GTX common stock on the most recent
trading day prior to the date of such investment, and if such Third Party investment occurs
concurrent with the initial public offering, then the price per share at which stock is offered to
the public), multiplied by the number of shares issued to such Third Party investor.



     1.28 “Product” shall mean any pharmaceutical product for human use within the Field containing
Toremifene as a therapeutically active ingredient.



     1.29 “Regulatory Approval” shall mean all governmental approvals required to import, market,
promote and sell the Product for use in the Field in any given country or territory in the GTX
Territory, including but not limited to, product registrations, medical approvals and price and
marketing approvals.



     1.30 “ROW Territory” shall mean the GTX Territory except the North American Territory and
Japan.



     1.31 “Sales of Generic Product” shall mean the documented sale and use of a Generic Product.



     1.32 “Specifications” shall mean the current specifications (as of the Amendment Date) for the
Orion Product, as such specifications are, with regard to [ * ] containing Toremifene, set forth
in the Orion NDA [ * ] approved by the U.S. FDA, and with regard to [ * ] and [ * ]
tablet of Orion Product set forth in Schedule C (Copies of such current specifications are set
forth in Schedule C attached hereto and made a part hereof.) The Specifications shall also include
any other modified or additional specifications applicable to Orion Product which may be
manufactured by Orion, pursuant to Section 16.3 or 16.4. Schedule C may be amended from time to
time as necessary to reflect modifications to the Specifications that may be implemented pursuant
to Section 16.3 or to include Specifications for any Other Product that Orion may agree to
manufacture pursuant to Section 16.4.



     1.33 “Term” shall mean the period commencing on the Amendment Date and continuing, on a
country by country basis until the date of expiration or invalidation of the last to expire or be
invalidated of the GTX Patent Rights, subject to earlier termination under Section 20 as provided
herein.



     1.34 “Third Party” or “Third Parties” shall mean any party or parties other than GTX, Orion,
an Affiliate of GTX, or an Affiliate of Orion.



     1.35 “Toremifene” shall mean [ * ].



     1.36 “Trademarks” shall mean the trademarks GTX selects and registers for the Product in the
Territory in accordance with Section 9 of this Agreement.




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




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     1.37 “U.S. FDA” shall mean the United States Food and Drug Administration and any successor
regulatory agency.



     1.38 “U.S. IND” shall mean an Investigational New Drug Application filed with the U.S. FDA.



     1.39 “U.S. NDA” shall mean a New Drug Application filed with the U.S. FDA.



     1.40 “Upfront and Milestone Income” shall have the meaning provided in Section 3.1.1(c).



     1.41 “Valid Claim” shall mean a claim of an issued patent which has not expired and which has
not been held revoked, invalid or unenforceable by decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed with the time allowed for appeal having
expired, and which has not been admitted to be invalid through reissue or disclaimer or otherwise.



2. GRANT AND SCOPE OF RIGHTS GRANTED




     2.1 Orion Grants to GTX



          2.1.1 License Grants. Orion hereby grants to GTX:




               (i) an exclusive right and license, with the right to grant sublicenses as provided in Section
2.1.4, under Orion Patent Rights and Orion Know-How, to develop, use, have used, sell, have sold,
import, market and distribute the Product in the North American Territory and in Japan in the
Field;



               (ii) a non-exclusive right and license, with the right to grant sublicenses as provided in
Section 2.1.4, under Orion Patent Rights and Orion Know-How, to develop, use, have used, sell, have
sold, import, market and distribute the Product in the ROW Territory for exclusive use in the
Field;



               (iii) a non-exclusive license, under the Orion Patents and Orion Know-How, to perform research
and preclinical development activities in accordance with Section 2.5 using the Powder (as defined
in Section 13.6.2) to be provided to GTX pursuant to Section 13.6.2; and



     Licenses under Sections 2.1.1 (i) and (ii) may be expanded to include the right to make and
have made Products as provided in Sections 7.6, 13.9, 15.1, 16.3.2, 16.4 and 20.2.2 on such terms
as are set forth in such Sections.



     For the avoidance of doubt, nothing herein shall limit or restrict or be construed to limit or
restrict Orion from using, and GTX acknowledges that Orion may use Toremifene and Product as a
reference compound and/or product in its R&D and business activities.



          2.1.2 Manufacturing Rights Reserved. Except as otherwise provided in Sections 7.6, 13.9, 15.1,
16.3.2, 16.4 and 20.2.2, Orion retains the exclusive right to manufacture





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





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or have manufactured
Toremifene, Orion Product and Product including, without limitation, any Toremifene and Orion
Product to be supplied to GTX under this Agreement and subject to Sections 7.6, 13.9, 15.1, 16.3.2,
16.4 and 20.2.2 herein, during the Term GTX undertakes to purchase all its requirement of Product
exclusively from Orion.




          2.1.3 Use of Orion Know-How. Under the licenses granted pursuant to Sections 2.1.1 (i)-(ii),
GTX shall, subject to the terms and conditions of this Agreement, including without limitation
Section 8, have the right to use and reference Orion Know-How in support of GTX’s clinical trials
and applications for Regulatory Approval within the Field for the Product in the GTX Territory.
Subject to the license rights granted hereunder, Orion retains full ownership rights to all Orion
Know-How.




          2.1.4 Sublicensing. GTX shall have the right to sublicense its rights received under this
Agreement in the GTX Territory to any Third Party, provided that GTX shall notify Orion within
fifteen (15) days after execution of an agreement between GTX and a GTX Unaffiliated Sublicensee.
GTX shall endeavor to include in its agreement with each GTX Unaffiliated Sublicensee a provision
stating that, upon termination of this Agreement, such Sublicensee and Orion shall discuss, and as
appropriate, negotiate the terms and conditions under which Orion and such sublicensee would be
willing to collaborate with regard to the further development and/or commercialization of the
Product for use in the Field in which GTX and such sublicensee were previously developing and/or
commercializing Products, provided that any such further development and/ or commercialization of
the Product by Orion and such sublicensee shall be subject to and conditioned by a definite written
agreement, if any, accepted and signed by duly authorized representatives of Orion. GTX shall
forward to Orion a complete copy of each sublicense agreement. No sublicense shall relieve GTX of
any of its obligations or commitments under this Agreement and GTX shall cause its Affiliates and
GTX Unaffiliated Sublicensees to comply with all of GTX obligations and commitments under this
Agreement.




     GTX shall remain jointly and severally liable to Orion with its Affiliate(s) and GTX
Unaffiliated Sublicensee(s) that obtain a sublicense under the licenses granted to GTX pursuant to
Section 2.1.1 for performance of GTX’s obligations under this Agreement. GTX shall be responsible
for complying and ensuring that such of its Affiliates and GTX Unaffiliated Sublicensees, as
applicable, comply with all relevant laws, regulations and requirements relating to the
importation, packaging, distribution, marketing, promotion, sale and use of Product in the GTX
Territory.



     Orion shall have the right to propose to GTX one or more potential sub-licensees for the
Product for use in the Field in Japan, South Korea and China (including, for the purpose of this
Agreement, the People’s Republic of China and Taiwan). GTX shall consider such proposal(s) in good
faith when appointing a sub-licensee for the Product for use in the Field for Japan, South Korea
and China. After the Amendment Date, Orion may disclose to its current licensee for
Toremifene in the breast cancer field in the USA, Japan, South Korea and China the existence
of this Agreement and the fact that it pertains to the development and commercialization of
Toremifene in the Field, [ * ] .



          2.1.5 GTX Rights of First Negotiation




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





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               (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 anti-estrogens and/or SERMs, including analogs,
metabolites, and/or derivatives thereof, 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”). Within thirty (30) days 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 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 within ninety (90) days 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 the thirty (30) day period, 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 within the ninety day (90)
period, GTX shall have no further rights in the anti-estrogens and/or SERM including analogs,
metabolites, and/or derivatives thereof, and Orion shall be free to contract with a Third Party
concerning same or itself pursue the development, registration, promotion, marketing, sales and
distribution of such Additional Product.



               (b) During the term of any Orion Patent or pendency of Orion Patent Application in the
relevant country, Orion grants GTX, on a country by country basis and 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 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.



                    (i) If after the Amendment Date, a Third Party (including without limitation an Orion
Unaffiliated Sublicensee or a GTX Unaffiliated Sublicensee) approaches Orion in writing and
indicates its desire to obtain a license and/or other rights from Orion to conduct Other
Activities, or if an Orion Affiliate refers such a Third Party having such interest to Orion, then
Orion shall advise such Third Party to approach GTX and discuss such Other Activity with GTX. Orion
shall for a period of two hundred and ten (210) days from the date that Orion notifies GTX in
writing that a Third Party has an interest in an Other Activity, refrain from granting such Third
Party such license and/or other rights to conduct such Other Activities. If GTX desires to obtain a
license and other support from Orion to conduct such Other
Activities (alone or together with such Third Party) GTX shall notify Orion in writing
thereof. If GTX so notifies Orion, then the Parties shall negotiate exclusively with each other
the terms of a binding, commercially reasonable license agreement under which Orion would grant GTX
a license to conduct such Other Activities and provide other related support to GTX, provided that
GTX’s right to conduct such Other Activity shall be subject to and conditioned by, and become




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




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effective only upon the execution by the Parties of a separate, mutually acceptable written
agreement, if any, with respect thereto. Such negotiations, if any, shall continue for up to one
hundred and eighty (180) days after Orion receives such notification from GTX or until the expiry
of said period of two hundred and ten (210) days, which ever is earlier (hereinafter referred to as
“Negotiation Period”). If the Parties, despite conducting good faith negotiations, if any, are
unable to or do not finalize and execute a binding license agreement within the Negotiation Period,
then GTX shall have no rights with respect to such Other Activities, and Orion and/or its Affiliate
shall have the right to conduct such Other Activities alone or together with a Third Party(ies) or
grant a Third Party a license and/or other rights from Orion to conduct Other Activities without
any obligation to GTX.



                    (ii) If after the Amendment Date a Third Party (including without limitation an Orion
Unaffiliated Sublicensee or a GTX Unaffiliated Sublicensee) approaches GTX or a GTX Affiliate and
indicates its desire to obtain a license and/or other rights to conduct Other Activities, then GTX
shall Promptly notify Orion in writing. Within thirty (30) days after GTX provides any such notice
to Orion, GTX shall inform Orion if GTX desires to negotiate the terms and conditions under which
GTX would be willing to obtain a license from Orion to conduct the Other Activities that are the
subject of such notice. If GTX so notifies Orion of its interest, then the Parties shall negotiate
exclusively with each other a letter of intent providing for the material, commercially reasonable
terms and conditions under which Orion would be willing to grant GTX a license to conduct such
Other Activities and provide other related support to GTX. Such negotiations shall continue for up
to one hundred and eighty (180) days after Orion receives such notification from GTX. If GTX fails
to provide written notice to Orion of GTX’s interest in conducting such Other Activities by the end
of such thirty (30) day period, or if the Parties, despite conducting good faith negotiations, are
unable to finalize such a letter of intent within such one hundred and eighty (180) day period,
then GTX shall have no further rights with respect to such Other Activities, and Orion shall have
the right to grant to such Third Party a license and/or other rights to conduct such Other
Activities without further obligation to GTX with respect to such Other Activities. If the Parties
finalize a letter of intent pursuant to this subsection (ii) providing for the material terms and
conditions under which GTX would obtain a license conduct Other Activities within such one hundred
and eighty (180) day period, then the Parties shall promptly thereafter meet to negotiate an
agreement setting forth more fully the terms and conditions contained in such letter of intent as
well as other applicable terms and conditions typically contained in agreements of similar nature,
provided that GTX’s right to conduct such Other Activity shall be subject to and conditioned by,
and become effective only upon the execution by the Parties of a separate, mutually acceptable
written agreement, with respect thereto, if any, and further provided that neither GTX nor Orion
shall either itself conduct such Other Activities or grant any Third Party the right to do so
unless (I) GTX has provided Orion notice that it is not interested in conducting such Other
Activity, or (II) GTX has failed to provided Orion with such notice of its interest in conducting
such Other Activity within such thirty (30) day period, or (III) the Parties fail to agree upon the
terms of a letter of intent or
execute such agreement within the applicable one hundred eighty (180) day period, which ever
of items (I)-(III) occur first.



                    (iii) If after the Amendment Date Orion or an Orion Affiliate desires to initiate the conduct
of Other Activities, then Orion shall promptly so notify GTX in




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





9.









 







writing. Within thirty (30) days
after GTX receives any such notification from Orion, GTX shall inform Orion if GTX desires to
negotiate the terms and conditions under which Orion would be willing to grant GTX a license and
other support from Orion to conduct the Other Activities that are the subject of such notice. If
GTX so notifies Orion of its interest, then the Parties shall negotiate exclusively with each other
on a binding, commercially reasonable license agreement under which Orion would grant GTX a license
to conduct such Other Activities and Orion would provide other related support to GTX, provided
that GTX’s right to conduct such Other Activity shall be subject to and conditioned by, and become
effective only upon the execution by the Parties of a separate, mutually acceptable written
agreement, if any, with respect thereto. Such negotiations shall continue for up to one hundred and
eighty (180) days after Orion receives such notification from GTX. If GTX fails to provide written
notice to Orion of GTX’s interest in conducting such Other Activities by the end of such thirty
(30) day period, or if the Parties, despite conducting good faith negotiations, are unable to
finalize and execute a binding license agreement within such one hundred and eighty (180) day
period, then GTX shall have no rights with respect to such Other Activities, and Orion or its
Affiliate shall have the right to conduct such Other Activities alone or together with a Third
Party(ies) without any obligation to GTX. Orion shall not grant a license to any Third Party to
commercialize products containing Toremifene for such Other Activities unless and until (I) GTX has
provided Orion notice that it is not interested in conducting such Other Activity, or (II) GTX has
failed to provide Orion with such notice of its interest in conducting such Other Activity within
such thirty (30) day period, or (III) the Parties fail to execute such binding license agreement
within such one hundred eighty (180) day period, which ever of items (I)-(III) occur first.



                    (iv) If GTX desires to conduct Other Activities, then GTX shall promptly notify Orion in
writing of GTX’s desire to conduct such Other Activity and the terms and conditions under which GTX
would be willing to obtain a license to conduct such Other Activities and other related support
from Orion, provided that any such license to GTX to conduct such Other Activity shall be subject
to and conditioned by, and become effective only upon the execution by the Parties of a separate,
mutually acceptable written agreement, if any (“Additional Agreement”). If GTX so notifies Orion of
its interest, then the Parties shall discuss, and as appropriate, negotiate exclusively with each
other with regard to an Additional Agreement for up to one hundred and eighty (180) days after
Orion receives such notification from GTX. If the Parties are unable to or do not finalize and
execute such Additional Agreement within such one hundred and eighty (180) day period, then GTX
shall have no rights with respect to such Other Activities, and Orion or its Affiliate shall have
the right to itself conduct such Other Activities or to grant to such Third Party a license and/or
other right to conduct such Other Activities without further obligation to GTX with respect
thereto.



                    (v) Any deadlines provided in this Section 2.1.5(b) may be extended by mutual written
agreement of the Parties. GTX’s rights under this Section 2.1.5(b) shall apply on an indication by
indication basis.



     2.2 No Implied Licenses. Any rights not expressly granted by either Party to the other Party
in this Agreement are expressly reserved by the Party owning or controlling such rights and,
accordingly, no licenses other than those specified herein shall be deemed granted by this
Agreement by implication, estoppel or otherwise.




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




10.









 





     2.3 United States Government Rights. In the event it is determined that any GTX Patent Rights
were developed with the support of the United States Government or any agency thereof (the
“Government”), the Government will retain rights in the GTX Patent Rights as set forth in Title 35
U.S.C. §200 et seq. All rights herein granted to GTX are subject to any such rights held by the
Government and further subject to any restrictions or obligations that may be imposed by the
Government pursuant to such rights, at such time that it is determined.



     2.4 Orion’s Right of First Negotiation.



          2.4.1 Whereas Orion has considerable knowledge and experience in the marketing, sales and
distribution of pharmaceutical products in, inter alia, Scandinavia (which term shall for purpose
of this Section 2.4 comprise the countries of Denmark, Finland, Norway and Sweden), GTX undertakes
to regard Orion as its preferential partner for the marketing, sales and distribution of the
Product in Scandinavia for use in the Field. Consequently, GTX grants, and shall cause its
Affiliates and Unaffiliated Sublicensees who receive a sublicense under the license granted to GTX
pursuant to Section 2.1.1 in Scandinavia to grant, to Orion a right of first negotiation to
negotiate in good faith an agreement(s) under commercially reasonable terms and conditions
regarding the marketing, sales and/or distribution by Orion of the Product in Scandinavia for use
in the Field, with the express understanding that such commercially reasonable terms and conditions
shall not comprise an obligation to develop and register the Product for use in the Field in any
country of Scandinavia.




          2.4.2 Within thirty (30) days after Orion’s receipt of a first written offer from GTX
regarding commercially reasonable terms and conditions governing such rights, Orion shall notify
GTX in writing if it wishes to negotiate the terms and conditions under which Orion could obtain
the rights contemplated in this Section 2.4. Should Orion so exercise such right, the Parties shall
negotiate exclusively with each other and in good faith the commercially reasonable terms and
conditions for a license and distribution agreement for the marketing, sales and distribution by
Orion of the Product in Scandinavia for use in the Field, such negotiations to be completed within
one hundred and eighty (180) days from the date of Orion’s notification to GTX. Any deadlines may
be extended by mutual agreement upon reasonable request. If Orion fails to provide written
notification to GTX by the end of the thirty (30) day period; Orion notifies GTX that it does not
wish to enter into negotiations; or the Parties, despite conducting good faith negotiations, are
unable to finalize the material commercial terms of agreement within such one hundred and eighty
(180) day period (any such event, a “Termination of the Orion Right”), Orion shall have no further
right under this Agreement to market, sell and distribute the Product in Scandinavia and GTX shall
be free to offer to or enter into an agreement with any Third Party or any GTX Affiliate with
respect to such activities after the Termination of the Orion Right occurs.




          2.4.3 In the event that GTX’s Unaffiliated Sublicensee for Product for use in the Field in the
USA does not obtain the right and license to sell, have sold, import, market and
distribute the Product in the Field in Europe at the time of execution of the sublicense
agreement for the Product for use in the Field in the USA, then Orion shall, on the terms and
conditions of Sections 2.4.1 and 2.4.2, have a right of first negotiation to negotiate in good
faith an agreement(s) under commercially reasonable terms and conditions regarding the marketing,
sales and/or distribution of the Product for use in the Field in Europe.





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




11.









 








     2.5 Use of Toremifene by GTX for Research. Subject to Sections 2.1.1 (iii) and 13.6.2, GTX
may use the Powder provided to it pursuant to Section 13.6.2 to perform stability studies and other
activities with respect to Products for use in the Field that are necessary for supporting
Regulatory Approval of Products or expanding the indications for Products within the Field. GTX
shall, upon Orion’s request therefor, provide Orion with written updates of any and all activities
undertaken by or on behalf of it pursuant to this Section 2.5, and with the results thereof in
reasonable detail.



     2.6 Prohibited Actions. During the Term of this Agreement, Orion shall not grant any rights
to any Third Party that are inconsistent with the licenses granted to GTX pursuant to Section
2.1.1.



3. PAYMENTS




     3.1 Types of Payments. For the rights, privileges and licenses granted hereunder, GTX shall
pay Orion in the manner provided as follows:



          3.1.1 In the event GTX or its Affiliate receives Upfront and Milestone Income (as defined in
Section 3.1.1(c)), GTX shall pay Orion as follows:




               (a) Any Upfront and Milestone Income shall first be applied to [ * ] both prior to and
after the Amendment Date, and also for the [ * ] .



               (b) Upon full reimbursement of such [ * ] pursuant to Section 3.1.1 (a), any remaining
Upfront and Milestone Income (the “Net Upfront and Milestone Income”) shall then be paid by GTX to
Orion as follows:



                    (i) GTX shall pay Orion [ * ] of the portion of Net Upfront and Milestone Income that is [ * ] ; and



                    (ii) [ * ] of the portion of the Net Upfront and Milestone Income that is [ * ] .



               (c) For the purposes of this Agreement, “Upfront and Milestone Income” shall mean any bona
fide consideration (either in cash or non-cash form) received by GTX or its Affiliate from a GTX
Unaffiliated Sublicensee for sublicensing GTX’s rights in and to the Product for use in the Field
in the GTX Territory excluding: (i) Royalty Income (as defined in Section 3.1.4); (ii) cost of
goods payments for supply of Product manufactured by Orion and supplied at the prices set forth in
Section 13 herein below, or payments to reimburse GTX’s fully burdened costs of manufacturing or
having manufactured Product by or on behalf of GTX as permitted under this Agreement; (iii) in the
form of a loan; or (iv) for the purchase of an
equity interest in GTX (except to the extent such purchase price is a Premium over the fair
market value of such stock, in which case the Premium, but not the portion of such price that is at
the fair market value of such stock, shall be included in Upfront and Milestone Income).
Notwithstanding the foregoing, if GTX receives Upfront and Milestone Income received in the form
described in (ii) or (iii) [ * ] . For example and without limitation, if [ * ] .




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




12.









 





          3.1.2 If` GTX is Acquired prior to the first Regulatory Approval of Product for use in the
Field, then GTX shall pay to Orion an amount equal to the lesser of one million dollars
($1,000,000) or [ * ] of the fair market value of GTX at the time of such acquisition.
“Acquired” means that GTX either (i) sells all or substantially all of its assets to a Third Party,
or (ii) is merged with or consolidated or reorganized into a Third Party, or becomes a subsidiary
of a Third Party, and, as a result of such transaction, the stockholders of GTX immediately prior
to such transaction own less than fifty percent (50%) of the surviving parent entity.




          3.1.3 For commercial sales of each Product by GTX, or its Affiliates in a country of GTX
Territory commencing on the First Commercial Sale of Product, GTX shall during the Term pay Orion a
running royalty in the amount of [ * ] of Net Sales of Product on a country by country basis,
subject to the provisions of Sections 3.1.6 and 20.2.2.




          3.1.4 Subject to the provisions of Sections 3.1.6 and 20.2.2, in the event GTX receives
running royalty income from GTX Unaffiliated Sublicensees for sublicensing GTX’s rights in and to
the Product for use in the Field and/or based upon sales by GTX Unaffiliated Sublicensees of
Product for use in the Field in the Territory (“Royalty Income”), GTX shall during the Term pay
Orion the lesser of, on a country by country basis, either (i) [ * ] of such Royalty Income; or
(ii) [ * ] of such GTX Unaffiliated Sublicensees, provided, however, that in no event shall the
amounts due to Orion pursuant to this Section 3.1.4 be [ * ] of Net Sales of such GTX
Unaffiliated Sublicensees.




          3.1.5 As of December 31, 2000, an upfront license fee of four hundred thousand dollars
($400,000) (the “Upfront License Fee”), was paid in full by GTX to Orion. This payment shall be
creditable by GTX against fees or payments due to Orion with respect to Upfront and Milestone
Income pursuant to Section 3.1.1.




          3.1.6 If a Generic Product is sold in any Major Country of the GTX Territory, and, for two (2)
succeeding calendar quarters the Sales of Generic Product in that country [ * ] of the sales of
Product (calculated on a unit basis) in that country, then the royalty on Net Sales owed by GTX to
Orion under Section 3.1.3 and the payments due to Orion on Royalty Income pursuant to Section
3.1.4, respectively, shall be reduced to [ * ] of the amount otherwise due to Orion pursuant to
either Section 3.1.3 or 3.1.4, as applicable, with regard to such country with such reduction to be
applicable to the immediately succeeding calendar quarter only.




     3.2 Non-Refundability. All milestone payments GTX makes to Orion pursuant to Section 3.1.1
shall be non-refundable once paid. However, if this Agreement is terminated for any reason prior to
a given milestone payment becoming due or if the events specified for a given milestone payment do
not occur, then GTX shall have no obligation to make such milestone payment.



     3.3 Royalty Reports and Payments. Commencing with the first Calendar Quarter in which GTX,
its Affiliates or a GTX Unaffiliated Sublicensees make the First Commercial Sale of the Product,
GTX shall provide Orion with a written report of Net Sales and Royalty Income on a
country-by-country basis within forty-five (45) days after the last day of March, June, September
and December for Royalty Income accruing on Net Sales during the three (3)




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




13.









 







preceding calendar
months. Concurrently with the submission of each such written report, GTX shall pay or cause to be
paid to Orion the total amount of royalties shown to be due thereon.



     3.4 Currency. GTX shall make all Upfront and Milestone Income and royalty payments to Orion
pursuant to Section 3.1 in U.S. Dollars except that GTX shall make all cost of goods payments to
Orion pursuant to Section 13 in euros. Where royalty payments are made, payments earned shall be
first determined by GTX in the currency of the country where the Net Sales on the sales giving rise
to payments were made and then converted directly to its equivalent in U.S. dollars. The rates of
exchange for converting the currencies involved to U.S. dollars shall be the Foreign Exchange Rates
quoted in the Wall Street Journal rate on the last business day of the quarterly period in which
the royalty payments were earned.



     3.5 No Royalties Payable Between Affiliates. No royalties shall be payable to a Party on
sales between the other Party, its Affiliates or between the Party’s Affiliates.



     3.6 No Multiple Royalties. No multiple royalties shall be payable because the Product, its
manufacture, use or sale is or shall be covered by multiple patents.



4. LIAISON




     Representatives of the Parties shall meet bi-annually or as otherwise agreed to review
development, sales and marketing activities for the Product for use in the Field in the GTX
Territory, with the exact dates and locations of such meetings to be mutually agreed upon. Such
meetings shall alternate between GTX’s and Orion’s offices or be at other mutually agreed upon
locations, with each Party to be responsible for the travel and living costs and expenses of its
own representatives attending such meetings.



5. PAYMENT, RECORD KEEPING AND AUDIT RIGHTS




     5.1 Method of Payment. In the event of any required tax withholding, the paying Party will
provide the receiving Party with any relevant certificates or documents required for national,
state or local tax credit and reporting purposes. Payments hereunder shall not be creditable
against any other amounts payable by a Party under this Agreement, except as otherwise expressly
stated herein. All payments shall be made by bank wire transfer (e.g., “SWIFT” or other comparable
electronic transfer method) to such account(s) as the receiving Party shall designate beforehand in
writing to the paying Party. Payments shall be deemed paid once funds are freely available to the
receiving Party at such account(s).



     5.2 Late Payments. The Party entitled to payment hereunder reserves the right to charge the
paying Party interest on any amounts owing from the paying Party which are overdue by more than
fourteen (14) business days at a rate of [ * ] per annum, or the maximum rate allowed by law,
whichever is lower, calculated from the date any payment was due and payable.



     5.3 Record Keeping and Audit Rights. Each Party shall keep or cause to be kept accurate
records relating to Net Sales, royalties, development and any other costs and expenses subject to
payment, deduction or reimbursement by either Party to the other Party in sufficient detail to
enable the amounts payable hereunder to be determined. Upon the written request of




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




14.









 







either Party
(but not more frequently than once in any calendar year), the requesting Party may retain an
independent certified public accountant, subject to approval by the other Party (which approval
shall not be unreasonably withheld), to review such records to verify the accuracy of the payments
made or payable hereunder. Such accountant shall be required to execute a confidentiality agreement
in a form reasonably acceptable to the audited Party and shall report to the auditing Party only
the amount of any underpayment or overcharge. Within ten (10) business days after completion of
such review, the Parties shall reconcile any underpayment or overcharge. The auditing Party shall
pay the cost of any review of records conducted at its request under this Section. However, if the
review establishes underpayment or overcharge by the audited Party of over three percent (3%)
during the period of the review, the audited Party shall promptly reimburse the auditing Party for
the fees and expenses of the accountant. Such audit rights may be exercised by the Parties only
with respect to records for the current calendar year and the preceding two (2) calendar years.



6. GTX PRODUCT MARKETING AND SALES ACTIVITIES




     6.1 Minimum Sales Requirements for USA.



          6.1.1 Levels of MSRs. GTX shall have annual minimum sales requirements for Product for use in
the Field (“MSRs”) in the second year and fourth year after Product Launch in the USA equal to [ * ] of GTX’s annual Product Sales Projections (as defined below) in the USA. To establish such
projections for the purpose of the foregoing sentence, GTX shall provide to Orion annual Product
Sales Projections in the USA within ninety (90) days after GTX, its Affiliate or Unaffiliated
Sublicensee completes the last pivotal clinical trial as provided in the GTX Final Development and
Registration Plan for Product in the USA. The Parties shall set forth in Schedule D GTX’s MSR
obligations within sixty (60) days after GTX provides such projections, and such MSRs shall be made
a part hereof. Beginning with the [ * ] year after Product Launch in USA for use in the Field
until the end of the Term, GTX shall have an annual MSR equal to [ * ] of the average of GTX’s
Actual Product Sales (as defined below) in the USA for Product in the Field for the [ * ].
“Product Sales Projections” means GTX’s good faith estimates of the target patient population in a
given year for Products in the Field, multiplied by the price per tablet of Product for use in the
Field that GTX plans to be able to charge during the [ * ] after Product Launch. “Actual
Product Sales” means GTX’s, its Affiliate’s or a GTX Unaffiliated Sublicensee’s actual Net Sales of
Product in the Field during a given year in the USA.




     For example, in year [ * ] if the target patient population is [ * ] subjects in the
Field and the Product would be consumed [ * ] for the Field at a hypothetical price of [ * ],
GTX’s Product Sales Projections would [ * ]. The hypothetical price for a tablet set forth above
is hypothetical and was only used for the sole purpose of explaining the mechanism for calculating
the Product Sales Projections and MSRs. Nothing contained in such example shall be so construed to
deny the right of GTX to freely set its resale price of the Product.



          6.1.2 Product Launch Date. “Product Launch in USA” shall be determined by the date on which
the Product has received Regulatory Approval and is commercially available in the USA as follows:
(i) if such date occurs during the first six (6) months of any calendar year (i.e., January 1-June
30), Product Launch in USA shall be deemed to have





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




15.









 







occurred on January 1 of such calendar year, and
(ii) if such date occurs during the last six (6) months of any calendar year (i.e., July 1-December
31), Product Launch in USA shall be deemed to have occurred on January 1 of the following calendar
year.




          6.1.3 Adjustment. GTX’s annual Product Sales Projections for the Field in the USA shall be
subject to adjustment by written agreement of the Parties, with a corresponding adjustment in the
MSRs, in the event of government intervention in given markets (including, but not limited to,
government mandated health care reforms, rebates or regulatory changes), failure to obtain (or
delay in obtaining) approval for a Product indication in the Field, or other events or causes
affecting the market for the Product for use in the Field beyond the control of GTX, including but
not limited to lower than anticipated pricing approvals measured on an aggregate basis throughout
USA; GTX Patent Rights and/or Orion Patent Rights invalidation, infringement or expiration; Product
safety and/or efficacy issues and/or major therapeutic advances materially affecting the market
potential for the Product for use in the Field (including but not limited to new surgical
procedures or introduction of new competitive products with superior safety and/or efficacy
profiles); or a Force Majeure event (as described in Section 26).




          6.1.4 Failure to Achieve MSRs. If GTX’s annual Product Sales in USA for the Field are less
than the MSRs in any applicable calendar year, GTX shall, without prejudice to its payment
obligations under Section 3.1, pay Orion royalties corresponding to the “shortfall” between the
actual royalties paid by GTX for such year and the royalties which would have been payable pursuant
to Section 3.1 had GTX achieved the MSRs during such year. GTX’s payment of such “shortfall”
hereunder shall be Orion’s sole and exclusive remedy for GTX’s failure to achieve MSRs in USA for
such year. However, if GTX fails to pay such “shortfall,” then Orion may, without prejudice to its
right to such shortfall, also terminate this Agreement pursuant to Section 20.2.2.




     6.2 No Minimum Sales Requirements Outside of USA. GTX shall not have any MSRs with respect to
sale of the Product in any countries in GTX Territory outside of the USA.



     6.3 Marketing and Sales Efforts in the Major Countries



          6.3.1 Commercially Reasonable Obligation. On a country by country basis, subject to Sections
6.3 and 6.4, during the period commencing with Regulatory Approval in a Major Country, and for the
remainder of the Term, GTX, its Affiliate and/or a GTX Unaffiliated Sublicensee shall use
commercially reasonable efforts to promote, market, distribute and sell the Product for use in the
Field in the Major Countries. For purposes of this Section 6.3, “commercially reasonable” shall
mean using, in each of the Major Countries, an equivalent degree of effort as GTX, its Affiliate or
a GTX Unaffiliated Sublicensee would use to promote, market, distribute and sell a product of it
own that is of comparable market potential in the respective Major Countries during the same time
period (as determined by consideration of, without limitation, potential market, patent protection,
and availability of competitive products),
including but not limited to, engaging in the following activities (subject to any applicable
U.S. FDA restrictions or other applicable legal restrictions):





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




16.









 








               (a) Using reasonable diligence to establish and maintain good business relationships with
hospitals, health systems, doctors and other medical professionals in accordance with standard and
customary practices in the Major Countries;



               (b) Using commercially reasonable efforts to establish and maintain an adequate capacity of
sales personnel consisting of reasonably qualified personnel who have been certified, as trained by
GTX, its Affiliate or a GTX Unaffiliated Sublicensee, to promote and market the Product for use in
the Field in the Major Countries, and to provide such sales force with adequate sales and
promotional materials for the Product;



               (c) Promoting and detailing the Product for use in the Field throughout the Major Countries,
provided that GTX, its Affiliate or a GTX Unaffiliated Sublicensee may, in its discretion use
relatively greater promotional and detailing efforts (i) in some Major Countries than it uses in
other of such countries, and (ii) in some parts of each Major Country than in other parts thereof,
consistent with its overall marketing plan; and further provided, however, that the foregoing shall
in no event be deemed to limit GTX’s its Affiliate or a GTX Unaffiliated Sublicensee overall
obligations under the first paragraph of this Section 6.3.1.



               (d) Advertising the Product for use in the Field in professional journals and publications and
sponsoring or attending appropriate symposia, trade exhibitions and medical education programs in a
manner equivalent to that used for GTX’s, its Affiliate’s or a GTX Unaffiliated Sublicensee’s, as
applicable, own products of comparable market potential in such Major Country; and



               (e) Formulating and using reasonable efforts to implement annual sales and marketing plans for
the Product for use in the Field in the Major Countries and providing copies of such plans to Orion
for review and comment, provided that Orion shall not have approval rights with respect to such
plans.



          6.3.2 Sales Objectives and Other Factors for the USA. GTX and Orion shall agree in writing
upon annual target sales objectives for the Product for use in the Field in the USA, commencing
with the fourth calendar year after First Commercial Sale of the Product for use in the Field in
the USA, provided that such annual target sales objectives shall not be considered MSRs for any
purposes, but instead shall be used by the Parties for informational and planning purposes and
shall be one (1) factor, among others, to be considered in assessing whether GTX has complied with
its commercially reasonable obligations hereunder. GTX’s level of sales and marketing expenses for
the Product for use in the Field in the USA and events or causes affecting the market for the
Product for use in the Field beyond the control of GTX shall also be among the factors to be
considered in assessing whether GTX has complied with its commercially reasonable obligations
hereunder.




     6.4 Product Launch



          6.4.1 Timing of Launch. GTX shall use commercially reasonable efforts to launch the Product
for use in a given indication in the Field as soon as practical in every Major Country of the GTX
Territory where GTX, its Affiliates and/or GTX Unaffiliated Sublicensees have obtained Regulatory
Approval for such indication. Notwithstanding the foregoing, GTX, its






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




17.









 







Affiliate or a GTX
Unaffiliated Sublicensee may, acting in good faith in the exercise of its reasonable business
judgment, determine either to delay the launch of the Product for use in a given indication in the
Field or not to launch the Product for use in a given indication in the Field in any given country
in the GTX Territory other than a Major Country, which decision to delay or not to launch shall not
be deemed a failure to use commercially reasonable efforts. Further, GTX’s, its Affiliates’ or a
GTX Unaffiliated Sublicensee’s decision to delay the launch of the Product for use in the Field in
any Major Country for up to six (6) months after GTX or its Affiliates have obtained Regulatory
Approval in such country, shall not be deemed a failure to use commercially reasonable efforts
pursuant to Section 6.3 to the extent that GTX can demonstrate that such delay was attributable to
bona fide business reasons affecting the Product.




          6.4.2 Decisions Not to Launch. GTX shall promptly notify Orion in writing if GTX, its
Affiliate or a GTX Unaffiliated Sublicensee, as applicable, determines to delay the launch of the
Product for use in a given indication in the Field in any Major Country after obtaining Regulatory
Approval of Product therefor. If such decision is due to any reasons other than the potential for,
or the existence of, adverse business effects in such Major Country, then such decision shall be
deemed a material breach of this Agreement pursuant to Section 20.2.2 and GTX shall be subject to
the provisions of such Section within thirty days (30) after GTX’s decision not to launch in such
Major Country.




     6.5 Marketing Costs and Expenses. Except as other-wise provided herein or as otherwise
mutually agreed by the Parties, GTX, its Affiliate or a GTX Unaffiliated Sublicensee shall bear all
costs and expenses connected with its marketing and sales activities for the Product for use in the
Field and its performance under this Agreement.



     6.6 Marketing Plans and Reports.



          6.6.1 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 each Major Country for the following
calendar year, commencing with the calendar year in which Regulatory Approval is obtained in each
respective country. Such plans shall include the projected Annual Net Sales and the projected
advertising and promotion budgets for such year, and shall not be applicable to the calculation of
MSRs pursuant to Section 6.1, for which GTX shall separately provide information.




          6.6.2 Marketing and Sales Reports. GTX shall provide to Orion, within forty-five (45) days
after the end of each calendar year, a written marketing activities and sales report for each of
the Major Countries. The report shall include at least a description of sales, marketing and
promotion activities and a list of scientific conferences or other events involving the Product or
its therapeutic area, accompanied by a general description of the nature and extent of GTX’s
participation in such conferences or events.




7. GTX PRODUCT DEVELOPMENT AND REGISTRATIONS 




     7.1 GTX Development and Registration Activities.




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




18.









 





          7.1.1 GTX Activities. In accordance with the GTX Preliminary Development and Registration
Plan and the GTX Final Development and Registration Plan, GTX shall undertake development and
registration activities for the Product for use in the Field in the GTX Territory, including but
not limited to, conducting or sponsoring, and completing or having completed in accordance with
U.S. FDA regulations and Good Clinical Practice regulations under the European Union legislation
and directives requirements, all clinical studies and other activities required for Regulatory
Approval under the GTX Final Development and Registration Plan. Without limiting the provisions of
Section 7.6, GTX shall use its commercially reasonable efforts to pursue such development and
registration activities under the GTX Final Development and Registration Plan with the objective of
filing applications for Regulatory Approval in all Major Countries throughout the GTX Territory
according to the anticipated filing dates set forth in the GTX Final Development and Registration
Plan timetable. GTX’s Regulatory Approvals in the GTX Territory shall be owned solely by GTX.




          7.1.2 Orion Activities.




               (a) Orion shall use its commercially reasonable efforts to assist GTX in obtaining and
maintaining the U.S. FDA Regulatory Approval of Products and any other required Regulatory
Approvals in the Major Countries of the GTX Territory relating to the manufacture, use, marketing
or sale of Product for use in the Field (by providing to GTX relevant information, documents and
data in its possession in relation to regulatory inquiries during the Regulatory Approval process
for Products, necessary additional letters of cross-reference or authorization equivalent to those
described in Section 7.4, assistance in obtaining free sales certificates, and other similar
assistance).



               (b) Orion shall perform any stability testing for the bulk Orion Product to be manufactured
and supplied by Orion to GTX that is required by regulatory authorities in any Major Country. Such
testing shall be provided at no cost to GTX, except that GTX will reimburse Orion’s direct costs of
performing any such stability testing that must be conducted solely for the [ * ] tablet of the
Orion Product. Orion employees shall, at Orion’s cost and expense, have the right to participate in
all FDA and other regulatory agency meetings regarding the use of the Product in the Field.



               (c) Orion shall have no obligation to research, develop, register, commercialize any Product
or carry out any studies or testing in relation to Products, including without limitation with
respect to any new or additional strength, dosage form, formulation or route of administration of
the Orion Product or the Product, or provide any documentation, information or data relating to the
foregoing, except as expressly provided in Section 7.1.2(a) or otherwise set forth in this
Agreement, unless the Parties expressly mutually agree otherwise in writing after the Amendment
Date. Other than as expressly agreed in this Agreement, Orion shall have no obligation to fund or
pay for any of the costs and expenses of such activities. All studies, trials, tests, activities,
documentation, data and information required by any regulatory or other governmental agency or
which is necessary or useful for the research, development, registration or commercialization of
the Product shall, unless otherwise expressly agreed to herein, be for the sole cost and
responsibility of GTX.




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




19.









 





          7.1.3 FDA File. Any regulatory filings (including without limitation any DMFs that GTX may
develop if it obtains the right to manufacture Product) compiled and filed by or on behalf of GTX
shall remain the property of GTX, but GTX shall, upon request therefor by Orion, negotiate with
Orion the terms under which GTX would provide appropriate authorization letters to relevant
regulatory bodies to enable Orion to reference such regulatory filings for purposes of applying for
and supporting Orion’s applications for Regulatory Approval of products containing Toremifene
outside the Field.




     7.2 Development and Registration Costs. Except as otherwise expressly provided in this
Agreement or otherwise mutually agreed in writing by the Parties after the Amendment Date, GTX
shall bear all costs and expenses related to Product registration and regulatory activities,
including without limitation costs of filing, obtaining and maintaining all Regulatory Approvals
throughout GTX Territory, as well as all costs and expenses for the research and development of the
Product for use in the Field, provided that GTX shall not be responsible for any costs related to
the manufacture of the Orion Product (except for payments that GTX must make to Orion pursuant to
Section 7.1.2(b) or Section 13 (such costs collectively referred to herein as “Manufacturing
Costs”). Except for the Manufacturing Costs or as otherwise expressly provided in this Section 7,
Orion shall bear no responsibility for any costs or expenses related to Product registration,
regulatory, research or development activities in relation to the Product.



          7.2.1 Development and Registration Costs prior to Amendment Date. The Parties agree that GTX
shall, notwithstanding anything to the contrary in the Original Agreement or otherwise, also bear
all costs and expenses related to Product research, development, registration, regulatory
compliance and other activities relating to the development of Product that were incurred prior to
the Amendment Date by GTX (excluding any Manufacturing Costs) (hereinafter referred to as “Incurred
Costs”). Consequently, GTX shall forever release and discharge Orion of any and all claims that it
purports to have at the Amendment Date or may have thereafter against Orion with respect to
Incurred Costs.




     7.3 GTX Development and Registration Plan.



          7.3.1 Completion of GTX Final Development and Registration Plan. The GTX Preliminary
Development and Registration Plan was attached to the Original Agreement as Schedule B. GTX will
prepare a GTX Final Development and Registration Plan for each Major Country in a timely fashion
upon receiving approval from the appropriate regulatory authority in each Major Country of a plan
for regulatory approval in that country. Immediately upon completion of the GTX Final Development
and Registration Plan for each Major Country, a copy of such Plan shall be provided to Orion.




          7.3.2 Orion’s right to comment on and object to Plan. Orion shall have the right to comment
on each GTX Final Development and Registration Plan for each Major Country. Additionally, Orion
shall have the right to object to each GTX Final Development and Registration Plan for each Major
Country to the extent such plan could reasonably be deemed to affect adversely Orion’s development,
commercialization, sales or registration of Orion’s proprietary product Fareston(R) outside the
Field or Toremifene outside the Field. GTX undertakes to change and/or amend the GTX Final
Development and Registration Plan for each Major Country to the extent Orion has so objected
thereto as necessary to alleviate or obviate






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




20.









 







such adverse effect. Orion shall provide GTX with such comments and/or objections within
thirty (30) days from Orion’s receipt of the GTX Final Development and Registration Plan.




          7.3.3 Changes to Such Plan. GTX may modify the GTX Final Development and Registration Plan,
as GTX deems necessary and consistent with Section 7.3.1, but shall notify Orion of such changes.
Any changes to the GTX Final Development and Registration Plan for each Major Country shall also be
subject to Section 7.3.2.




     7.4 Orion Documentation and Data




          7.4.1 GTX Access to Orion Know-How. Orion has provided and shall continue to provide GTX with
copies of the Orion Know-How, documentation, information and data listed or referenced in the GTX
Preliminary Development and Registration Plan, and GTX shall be authorized to use and reference the
same in its applications for Regulatory Approval and regulatory compliance activities in relation
to such Regulatory Approvals. Any Product Drug Master Files (“DMFs”) compiled or owned by Orion
shall remain the property of Orion, but Orion shall, upon reasonable request therefor by GTX,
provide appropriate authorization letters to relevant regulatory bodies in the GTX Territory within
forty-five (45) days from such request to enable GTX to reference such DMFs for purposes of GTX’s
applications for Regulatory Approval and regulatory compliance activities in the GTX Territory as
provided for in Section 7.1. For the avoidance of doubt, neither Party is obligated to disclose the
contents of its DMFs to the other Party.




          7.4.2 GTX Access to Data. During the Term, Orion shall provide GTX, within forty-five (45)
days of receipt of a written request from GTX specifying in detail the documentation, information
and data requested, access to Orion Know-How that GTX reasonably requires for regulatory filings
for the use of Product in the Field in the GTX Territory. Upon GTX’s request, Orion shall provide
GTX with copies of such Orion Know-How referenced in the preceding sentence only in such form and
content as is available to Orion, provided that, upon Orion’s request, GTX shall reimburse Orion
for Orion’s direct out-of-pocket cost of making such copies and providing GTX with such Orion
Know-How.




     GTX shall also provide to Orion quarterly reports summarizing GTX’s progress under the GTX
Preliminary Development and Registration Plan and the GTX Final Development and Registration Plan.



          7.4.3 Letter of Cross Reference. Orion agrees that the Cross Reference letter dated December
10, 1999 from Orion to GTX shall remain in effect and may not be revoked by Orion unless this
Agreement is terminated. During the Term, Orion shall permit GTX, its Affiliates and the GTX
Unaffiliated Sublicensees to reference, and shall provide GTX with an appropriate authorization
letter to enable GTX, its Affiliates and the GTX Unaffiliated Sublicensees to reference, Orion’s
existing U.S. NDA [ * ] and all other applications or filings for Regulatory Approval for Orion
Products for use in the breast cancer indication and related DMFs that are identified in Schedule E
hereof (hereinafter “Orion Product Approvals”) for the purpose of applying for and supporting
Regulatory Approval of Products for use in the Field within the GTX Territory. Orion shall update
Schedule E from time to time during the Term to set forth all Orion Product Approvals and DMFs that
are owned and controlled by Orion. GTX






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




21.









 







recognizes that Orion has obtained the Orion Product Approvals solely for the purpose of its
proprietary product Fareston(R), and that nothing herein shall be construed so as to obligate Orion
to maintain or cause to be maintained any Orion Product Approvals solely for allowing GTX, its
Affiliates and/or GTX Unaffiliated Sublicensees referring thereto, provided that during the Term
Orion shall not withdraw such Orion Product Approvals in the absence of commercially justifiable
reasons in relation to Fareston(R).




          7.4.4 All requests by GTX to Orion for documentation, information or data, as agreed herein,
shall be addressed only to the attention of such person(s) as is/are designated in writing or in
electronic form by Orion from time to time.




     7.5 GTX Registration and Marketing Approval Applications. GTX, its Affiliates and/or GTX
Unaffiliated Sublicensees shall have the responsibility and the right to submit registration
applications for Regulatory Approval and marketing and price approval of the Product for use in the
Field within the GTX Territory.



     7.6 Failure to File or Extend. Orion shall have the right to terminate its obligations under
Section 7.1.2(a) and its obligations to manufacture and supply to GTX Orion Product upon one
hundred and twenty (120) days prior written notice to GTX, if either (I) Regulatory Approval has
not been granted for the Product for use in the Field in the USA by December 31, 2007, or (II) the
last Valid Claim included in the Orion Patent Rights in the USA expires (which the Parties
currently anticipate to occur in 2009) or is invalidated. Any such notice hereunder shall be given
no later than sixty (60) days after the occurrence of the applicable event giving rise to such
right, provided that GTX shall inform Orion in writing by December 31, 2007, whether or not
Regulatory Approval has been granted for the Product for use in the Field in the USA by such date.
The time for Orion to provide notice to GTX of its decision to exercise its right with regard to
the event described in item (I) shall be deemed to commence upon the receipt by Orion of such
notice from GTX, provided that nothing shall be construed so as to prevent Orion from exercising
its right with regard to the event described in item (I) if Orion finds out, either by itself or
through a Third Party that Regulatory Approval has not been granted for the Product for use in the
Field in the USA by December 31, 2007. Effective upon the date that GTX receives any notice from
Orion pursuant to this Section 7.6 and during the Term, Orion hereby grants GTX a contingent
license under the Orion Patent Rights and Orion Know-How and all other patents and patent
applications owned or controlled by Orion during the Term that relate to the manufacture, use or
sale of Toremifene or Orion Product (“Manufacturing Patents”) to make and have made Product for use
in the Field in the GTX Territory. Such license shall be exclusive with respect to Products for use
in the Field and in the North American Territory and Japan, and nonexclusive with respect to
Products for exclusive use in the Field in the ROW Territory. Orion shall as soon as practically
possible after providing any notice to GTX pursuant to this Section 7.6 provide GTX with such
then-existing manufacturing, process and quality control procedures, documentation and other
relevant know-how and information to the extent reasonably necessary to enable GTX to exercise its
manufacturing right pursuant to this Section 7.6 (hereinafter “Product Manufacturing Know-How”),
including without limitation providing up to ten (10) person-days of technology transfer assistance
at GTX’s site of manufacture of Product using Orion personnel skilled in such manufacturing
operations, at no charge to GTX.




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




22.









 





     At any time prior to December 31, 2007, GTX may propose to discuss whether Orion would be
willing either to commit to manufacture and supply to GTX Orion Product for a certain amount of
time to allow GTX to have uninterrupted supply during critical Product development or
commercialization periods, or to allow GTX to locate and qualify a Third Party manufacturer of
Orion Product for such purpose. Upon such request, the Parties shall promptly discuss whether or
not Orion is interested in supplying GTX with such needs of Orion Product. Nothing in this
paragraph shall be deemed to require Orion to take any action or to impose an obligation for, or
constitute a commitment by Orion in relation to such subject matter.



     7.7 Reimbursement of Orion Costs. Except as provided for otherwise in this Section 7, GTX
shall reimburse Orion for all costs and expenses incurred by Orion in fulfilling its obligations
under this Section 7. Orion shall issue an invoice for all such reasonable costs and expenses so
incurred during each Calendar Quarter and GTX shall effect payment of such invoice within thirty
(30) days from the date of the invoice.



8. CONFIDENTIALITY AND PUBLICITY 




     8.1 Confidentiality Obligation. Each Party shall hold the other Party’s Confidential
Information (as defined below) of which it becomes informed in connection with this Agreement or
the Original Agreement in strictest confidence and shall not disclose such Confidential Information
to Third Parties or otherwise use it, except to the extent such use or disclosure is expressly
permitted by the terms of this Agreement or is reasonably necessary for the performance of this
Agreement.



     8.2 Permitted Disclosures. Permitted disclosures of Confidential Information hereunder
include, but are not limited to: (A) disclosures to regulatory agencies to the extent required for
Regulatory Approval, including but not limited to, GTX Product registrations and applications in
the GTX Territory (to the extent expressly permitted hereunder), and (B) disclosures to the
Parties’ Affiliates, employees, agents and independent contractors (including clinical
investigators, consultants and contract research organizations) who have a bona fide “need to
know”, and GTX Unaffiliated Sublicensees, and prospective sublicensees, provided that for such
permitted disclosures under subsection (B) the disclosing Party shall obligate the recipients to
maintain the confidentiality of Confidential Information under terms substantially similar to those
contained in this Section 8.



     8.3 Confidential Information. “Confidential Information” includes, but is not limited to, any
information relating to the terms of this Agreement, the Original Agreement, the Product, the Orion
Product, GTX Know-How, GTX Patent Rights, Orion Patent Rights, Orion Know-How, GTX Preliminary
Development and Registration Plan, GTX Final Development and Registration Plan, clinical and
non-clinical studies involving the Product, and all sales and marketing plans for the Product, as
well as information concerning all other products and the business affairs, manufacturing processes
and other activities of the disclosing Party that are designated as confidential in writing or
orally disclosed, provided such oral disclosure is confirmed as confidential in writing within
thirty (30) days thereafter. However, Confidential Information shall not include any information:



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





23.









 





               (a) Publicly Available Information. Which at the time of disclosure is or later comes into
public domain by publication or otherwise through no fault of the receiving Party;



               (b) Previously Known Information. Which can be demonstrated by documentation or other
competent proof to have been in the receiving Party’s possession prior to disclosure;



               (c) Subsequently Received Information. Which is subsequently received by the receiving Party
from a Third Party who is not bound by any confidentiality undertaking to the disclosing Party or
to any of its Affiliates with respect to said information;



               (d) Independently Developed Information. Which is independently developed by or for the
receiving Party without reference to the disclosing Party’s Confidential Information; or



               (e) Legally Required Disclosures of Information. Which is legally required to be disclosed
pursuant to any statute or regulation or any judicial or administrative order including any
material or information requested by the Securities and Exchange Commission or Finnish equivalent
thereof to the extent that such information cannot be treated confidential.



     8.4 Duration of Confidentiality Obligation. The confidentiality obligations of the Parties
hereunder shall remain in effect during the Term and shall survive the termination or expiration of
this Agreement for any reason and be effective until the later of five (5) years after such
termination or expiration, or ten (10) years after the Amendment Date.



     8.5 Publicity and Announcements




          8.5.1 With regard to the existence and content of commercial terms and conditions of this
Agreement, unless agreed upon by the Parties, neither Party shall originate any publicity, news
release or other public announcement, written or oral, whether to the public press, stockholders or
otherwise, relating to this Agreement or any amendment hereto, without the approval of the other
Party, except as required by law, including, without limitation, provisions regarding the
disclosure requirement for publicly quoted companies, and then only to the minimum extent so
required, in which event such Party shall give the other Party a reasonable opportunity to review
the form and content of the announcement before such legally required announcement is made.




          8.5.2 GTX may originate any publicity, news release or other public announcement, written or
oral, whether to the public press, stockholders or otherwise, relating to the use of the Product in
the Field, provided that GTX forwards to Orion such publicity, news release or other public
announcement fourteen (14) days prior to such publicity, news release or other public announcement,
except as otherwise required by law or regulation. It is agreed that such publicity, news release
or other public announcement does not require the approval of Orion, unless Orion considers such
publicity, news release or other public announcement to (I) fall within the scope of Section 8.5.1;
or (II) be misleading or incorrect, in which case Orion





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





24.









 







shall, within five (5) business days after receiving such publicity, news release or other
public announcement, so notify GTX and provide written comments specifying changes that Orion
reasonably believes will correct such inaccuracy, except as otherwise required by law or
regulation. If requested by Orion, such publicity, news release or other public announcement shall
include wording to the effect that Toremifene is a proprietary compound of Orion, and that
Toremifene has been licensed by Orion to GTX for use in the Field.




9. TRADEMARKS 




     9.1 Use of Trademarks. GTX shall market and sell the Product for use in the Field in GTX
Territory only under Trademarks selected by GTX. GTX shall not select a Trademark which is
confusingly similar to the Orion trademark Fareston(R). GTX shall own and control all Trademarks
excluding, for the avoidance of doubt Fareston(R). GTX shall notify Orion if GTX decides to change,
alter, modify or replace the Trademark initially selected by it for the Product without the express
written prior approval thereof by Orion.



     9.2 Trademark Filing and Maintenance. GTX shall be responsible for filing, maintaining,
prosecuting and defending the Trademarks in the GTX Territory.



     9.3 Worldwide Trademark Enforcement. GTX shall be responsible for and control Trademark
prosecution, maintenance, and/or enforcement worldwide. If requested by Orion, GTX shall provide
Orion with copies of all documents relating to the maintenance of the Trademark in the GTX
Territory, at Orion’s expense.



10. PATENT OWNERSHIP AND WARRANTIES 




     10.1 Patent Ownership.



          10.1.1 Subject to the license rights granted to GTX hereunder, Orion retains full ownership of
all Orion Patent Rights and shall be responsible for filing, prosecuting, and maintaining Orion
Patent Rights as provided for in Section 11.




          10.1.2 Subject to the license rights granted to Orion hereunder, GTX retains full ownership of
all GTX Patent Rights and shall be responsible for filing, prosecuting, and maintaining GTX Patent
Rights as provided for in Section 11.




     10.2 Orion Patent Warranties. Orion warrants and represents that, to the best of its
management’s knowledge as of the Effective Date,: (A) Schedule B sets forth all of the Orion Patent
Rights as of the Effective Date and as of the Amendment Date which are directed to the composition
of matter, use or sale of the compound Toremifene per se; (B) Orion has not and will not grant,
license, convey, assign, and/or transfer to any Third Party any rights to Orion Patent Rights for
use in the Field, or any rights to manufacture the Product or Toremifene for use in the Field, or
other rights to any Third Party inconsistent with the licenses and other rights granted to GTX
hereunder, (C) based upon Orion’s reasonably diligent investigation, the Orion Patent Rights are
(i) valid, in full force, and enforceable and/or (ii) there are no existing valid Third Party
patents in the GTX Territory that might be infringed by the manufacture or sale of the Orion
Product by Orion to GTX under this Agreement, and (D) the use and sale of Products



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





25.









 







in the Field and in the GTX Territory by GTX, its Affiliates or Unaffiliated Sublicensees
pursuant to this Agreement will not, in the absence of a license from Orion, infringe any patents
owned or controlled by Orion other than the Orion Patent Rights. Additionally, Orion represents and
warrants to GTX that to the best of its management’s knowledge as of the Amendment Date, Orion has
not received any written claims from any Third Party alleging that the use of Toremifene in the
Field infringes such Third Party’s patent rights.



     10.3 GTX Patent Warranties. GTX warrants and represents that, to the best of its management’s
knowledge as of the Effective Date: (A) Schedule A sets forth all of the GTX Patent Rights as of
the Effective Date which cover the Product for use in the Field and that it had full right and
authority to grant to Orion and Orion Affiliate the rights granted to it under the Original
Agreement; (B) subject to Section 2.1.4, GTX has not and will not grant to any Third Party any
rights under the Orion Patent Rights or Orion Know-How inconsistent with GTX’s licenses under this
Agreement, and (C) the United States Government or any agency thereof should not exercise such
rights as set forth and/or referenced to in Section 2.3, if GTX’s development, registration and
commercialization of the Product for use in the Field will be carried out as agreed herein and (D)
(i) the GTX Patent Rights are valid, in full force, and enforceable and (ii) upon GTX’s reasonably
diligent investigation, there are no existing valid and enforceable Third Party patents in the GTX
Territory that might be infringed by the marketing, promotion, distribution, importation, offer for
sale or sale of the Product by GTX, its Affiliates and GTX Unaffiliated Sublicensees.



11. PATENT PROSECUTION AND INFRINGEMENT 




     11.1 Orion Patent Filing and Prosecution. Orion shall, at its sole expense, prosecute,
maintain and defend Orion Patent Rights in the GTX Territory and Orion shall control all Orion
Patent Rights filings and actions. Orion shall use its commercially reasonable efforts to obtain
extensions in the Major Countries in the GTX Territory in which such extensions are available.



     11.2 GTX Patent Filing and Prosecution. GTX shall, as its sole expense, file, prosecute,
maintain and defend GTX Patent Rights in the GTX Territory and GTX shall control all GTX Patent
Rights filings and actions. GTX shall use its commercially reasonable efforts to obtain GTX Patent
Rights protection and commercially reasonable efforts to obtain GTX Patent Rights extensions in any
countries in the GTX Territory in which such extensions are available.



     11.3 Notification of Infringement. The Parties shall promptly inform each other of any
information that comes to their attention involving actual or apparent infringements or
misappropriations of Orion Patent Rights, Orion Know-How, GTX Patent Rights, GTX Know-How, or
Trademarks by any Third Party, or claims of alleged infringement made by any Third Party in the GTX
Territory against Orion, its Affiliates, or Orion Unaffiliated Sublicensees, GTX, its Affiliates,
or GTX Unaffiliated Sublicensees, resulting from the manufacture, importation, marketing, sale or
use of the Product in the Field.



     11.4 Infringement of Third Parties Rights by Orion. Orion shall, at its sole discretion,
direct or defend in its own name and at its own expense any legal or other action or proceeding,
including any settlement or negotiation, with respect to any alleged infringement of



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





26.









 







a Third Party patent or other proprietary right as a result of Orion’s, its Affiliates’, or
Orion Unaffiliated Sublicensees’ manufacture of Toremifene or Orion Product for use in the Field,
excluding actions and proceedings covered by Section 11.5. During the time any such proceeding or
any appeal thereof is pending, Royalty Income payable by GTX under Section 3.1 in the country in
which such proceeding is pending shall be paid by GTX into an interest-bearing escrow account
pending the outcome of such proceeding. Upon a favorable final resolution of such proceeding or any
appeal thereof, GTX shall resume paying Orion the full royalties in such country, and all funds in
such escrow account shall be paid to Orion. Upon an unfavorable final resolution of such proceeding
or any appeal thereof, the funds in such escrow account shall be applied toward the damage award in
such action, if any, and the balance, if any, shall be paid to Orion. If Orion fails to defend such
proceeding or discontinues the defense, all funds in such escrow account shall be returned to GTX
and GTX shall have no further obligation to pay Royalty Income in such country.



     11.5 Infringement of Third Parties Rights by GTX. GTX shall, at its sole discretion, direct
or defend in its own name and at GTX’s own expense in the GTX Territory any legal or other action
or proceeding, including any settlement or negotiation, with respect to any alleged infringement of
a Third Party patent, trademark or other proprietary right as a result of GTX’s, its Affiliates’,
or GTX Unaffiliated Sublicensees’ making, having made, importing, marketing, distributing, using or
selling the Product in GTX Territory for use in the Field, excluding actions and proceedings
covered by Section 11.4.



     11.6 Infringement Indemnification.



          11.6.1 Orion Infringement Indemnification. Orion shall indemnify, defend and hold GTX
(including for purposes of this Section 11.6.1, GTX Affiliates and GTX Unaffiliated Sublicensees),
its and their officers, directors, and employees, and permitted successors and assigns, harmless
from and against any and all liabilities, damages, claims, demands, costs and/or expenses
(including reasonable attorneys’ fees) (collectively, “Losses”) claimed by any Third Party in any
patent or proprietary right infringement suit or action which may be brought as a result of
Orion’s, its Affiliates’, or Orion Unaffiliated Sublicensees’ manufacture of Toremifene or Orion
Product, except to the extent such Losses arise out of claims for which GTX shall defend, indemnify
and hold Onion harmless pursuant to Section 11.6.2, and further subject to the conditions of
indemnification set forth in Section 14.7.




          11.6.2 GTX Infringement Indemnification. GTX shall indemnify, defend and hold Orion
(including for purposes of this Section Orion’s Affiliates and Unaffiliated Sublicensees) its and
their officers, directors, and employees, and permitted successors and assigns, harmless from and
against any and all Losses claimed by any Third Party in any suits or actions relating to patent,
trademark or other proprietary right infringements as a result of GTX’s, its Affiliates’, or GTX
Unaffiliated Sublicensees’ making or having made, importing, marketing, using or selling the
Product or Other Product under the Trademark in GTX Territory for use in the Field, except to the
extent such Losses arise out of claims for which Orion shall indemnify, defend and hold GTX
harmless pursuant to Section 11.6.1, and further subject to the conditions of indemnification set
forth in Section 14.7.




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




27.









 








     11.7 Termination for Infringement of Third Party Rights. Should either Party be prevented by
reason of an adverse, non-appealable court or administrative proceeding, order or judgment or
arbitral award against it from manufacturing, making, using or selling the Orion Product and/ or
Product in any country within the GTX Territory as required or permitted under this Agreement,
then, as to such country or territory so affected, the other Party may, upon sixty (60) days prior
written notice thereof to the other Party, terminate this Agreement upon written notice to the
other Party with respect to such country, and the Parties shall make a final transition accounting
and settlement for outstanding bona fide costs, payments and expenses to which each Party is
entitled hereunder with respect to such country.



     11.8 Third Party Infringement of Orion Patent Rights.



          11.8.1 Orion Enforcement. Orion shall have the first right but not the obligation, to
commence, at its own expense appropriate measures to enforce Orion Patent Rights against
infringement by Third Parties relating to the manufacture, use, sale, offer for sale, or import of
products containing Toremifene for use in the Field, within a reasonable period of time after Orion
becomes aware of such infringement (including, but not limited to, by notifying the infringing
Third Party of such infringement and demanding that such Third Party cease and desist from such
infringement) and, if such infringement does not cease, commence a legal proceeding to enforce
Orion Patent Rights, if any, against Third Party infringements within a reasonable period of time
of the date Orion becomes aware of such infringement. Orion shall notify GTX promptly after Orion
becomes aware of such infringement, and, upon request therefor by GTX, keep GTX reasonably informed
regarding Orion’s intended strategy in such situation. During the time any such proceeding or any
appeal thereof is pending, no Royalty Income shall be payable under Section 3.1 in the country in
which such proceeding is pending. Upon a favorable final resolution of such proceeding or any
appeal thereof, GTX shall resume paying Orion the full royalties in such country, and GTX shall
also be liable for payment of any back royalties payable for such period for which such a
proceeding has been pending. Orion’s commencement of such proceeding shall be at Orion’s own
expense, provided that Orion shall be entitled to retain all recoveries in such proceeding or any
appeal thereof. Such commencement by Orion shall not relieve either Party of its obligations under
Section 11.6.




          11.8.2 GTX Enforcement.




               (a) Orion Patent Rights. If within a reasonable period of time from the date Orion becomes
aware of any alleged Third Party infringement of the Orion Patent Rights relating to the
manufacture, use, sale, offer for sale, or import of Products containing Toremifene for use in the
Field, either by notice from GTX or otherwise, Orion has not commenced a legal proceeding pursuant
to Section 11.8.1, or if at any time Orion discontinues the pursuit of such proceeding, GTX may, at
its option, commence, continue or intervene, as the case may be, in such proceeding, provided,
however, that with respect to any such proceedings in any country in the GTX Territory, GTX shall
first request Orion to notify GTX whether any Third Party has a right to enforce the relevant Orion
Patent Rights in the relevant countries, in which event Orion shall promptly respond to such
request, and further provided that GTX’s rights hereunder are subject and secondary to any rights
that Orion has granted to any Third Party prior to the Amendment Date in such country with respect
to enforcement of the relevant Orion Patent Rights. During the time any such proceeding or any
appeal thereof is pending, no



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




28.









 







Royalty Income shall be payable under Section 3.1 in the country in which such proceeding is
pending. Upon a favorable final resolution of such proceeding or any appeal thereof, GTX shall
resume paying Orion the full royalties in such country, and GTX shall also be liable for payment of
any back royalties payable for such period for which such a proceeding has been pending. GTX’s
commencement, continuation or intervention in such proceeding shall be at GTX’s own expense,
provided that GTX shall be entitled to retain all recoveries in such proceeding or any appeal
thereof. Such commencement, continuation or intervention by GTX shall not relieve either Party of
its obligations under Section 11.6.



     11.9 Third Party Infringement of GTX Patent Rights and Trademark.



          11.9.1 GTX shall have the sole right, but not the obligation, at its own expense, to commence
appropriate measures to enforce GTX Patent Rights and rights to Trademarks against Third Party
infringements (including, but not limited to, notifying the infringing Third Party of such
infringement and demanding that such Third Party cease and desist from such infringement) and, if
such infringement does not cease, commence a legal proceeding to enforce such GTX Patent Rights or
rights to Trademarks, if any against Third Party infringements. GTX’s commencement of such
proceeding shall be at GTX’s own expense, provided that GTX shall be entitled to retain all
recoveries in such proceeding or any appeal thereof. Such commencement by GTX shall not relieve
either Party of its obligations under Section 11.6.




     11.10 Mutual Cooperation. In the event of any infringement litigation in the GTX Territory
involving the Product or Orion Product or any Orion Patent Rights or GTX Patent Rights or the
Trademark, the non-prosecuting or non-defending Party shall render such reasonable assistance as
may be requested by the prosecuting or defending Party in connection with such infringement
actions. If Orion requests GTX’s assistance in connection with such infringement claims or actions,
Orion shall reimburse GTX for such direct, documented out-of-pocket expenses as are reasonably
incurred by GTX during the course of it providing such requested assistance. If GTX requests
Orion’s assistance in connection with such infringement claims or actions, GTX shall reimburse
Orion for such direct, documented out-of-pocket expenses as are reasonably incurred by Orion during
the course of it providing such requested assistance. Before incurring such expenses, the Parties
shall in good faith agree in writing on the nature and extent of assistance to be rendered, and an
estimate of the total expenses, which expenses shall be monitored periodically.



     11.11 Patent Challenges



          11.11.1 If GTX, its Affiliate, or GTX Unaffiliated Sublicensee, either directly or through a
contractor or agent, challenges the validity of any Orion Patent Rights in any Major Country within
the GTX Territory and does not cease such challenge within thirty (30) days of receipt of written
notice from Orion, then such challenge shall be deemed a material breach of this Agreement and
Orion shall have the right to terminate this Agreement by written notice with immediate effect, at
Orion’s sole discretion, in its entirety or with respect to such country.




          11.11.2 If Orion challenges the validity of any GTX Patent Rights in any Major Country in GTX
Territory other than Major Country that is a member of the European Union and does not cease such
challenge within thirty (30) days of receipt of written notice from GTX, then





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





29.









 







such challenge shall be deemed a material breach of this Agreement and GTX shall be entitled
to terminate this Agreement by written notice with immediate effect, at GTX’s sole discretion, in
its entirety or with respect to such country.




     11.12 Activities During Infringement Litigation



          11.12.1 In the event of any patent or trademark or other proprietary right infringement
litigation involving the Product in GTX Territory in which GTX defends or prosecutes such
litigation, GTX may, at any time following one hundred eighty (180) days after the commencement of
such litigation, request in writing that Orion suspend the manufacture of the Orion Product for use
in the Field in the part of the GTX Territory so affected pending resolution of such litigation if
GTX reasonably deems such action necessary or advisable to mitigate possible damages that may be
incurred during the pendency of such litigation. If Orion elects not to comply with such request
within thirty (30) days after receipt thereof, then all damages resulting from Orion’s continued
manufacturing of the Product for use in the Field in the part of the GTX Territory so affected
after Orion’s receipt of such request shall be borne by Orion and be subject to Orion’s
indemnification obligation to GTX pursuant to Section 14.6.1.




          11.12.2 In the event of any patent or trademark or other proprietary right infringement
litigation involving the Orion Product in the GTX Territory in which Orion defends or prosecutes
such litigation, Orion may, at any time following one hundred eighty (180) days after the
commencement of such litigation, request in writing that GTX suspend the import, distribution,
marketing, sale and use of the Product, and suspend Orion’s manufacture and supply of Orion Product
for GTX hereunder, in the part of the Territory so affected pending resolution of such litigation
if Orion reasonably deems such action necessary or advisable to mitigate possible damages that may
be incurred during the pendency of such litigation. If GTX elects not to comply with such request
within thirty (30) days after receipt thereof, then all damages resulting from GTX’s continued
importing, distribution, marketing, sale and use of the Product in the part of the GTX Territory so
affected after GTX’s receipt of such request shall be borne by GTX and be subject to GTX
indemnification obligation to GTX pursuant to Section 14.6.2. If GTX elects to comply with such
request, such compliance shall be considered a suspension of GTX’s marketing and sales obligations,
notwithstanding Section 6.




          11.12.3 In the event either Party receives a written claim of any alleged or actual
infringement of a Third Party patent or trademark or other proprietary right as a result of
Orion’s, its Affiliate(s) or Unaffiliated Sublicensee(s’) manufacturing of or selling Orion Product
to GTX, or GTX, its Affiliates, or GTX Unaffiliated Sublicensees making, having made, marketing,
using or selling the Product in GTX Territory for use in the Field, each Party shall so notify the
other Party and the Parties shall confer regarding the basis for such claim, and discuss how the
Parties may resolve the situation. Orion shall have the right to suspend its manufacture and supply
of the Orion Product in and/or to the part of the GTX Territory so affected upon twenty (20) days
prior written notice to GTX pending resolution of such claim or any related infringement
litigation, if necessary to mitigate damages that may be incurred. If Orion exercises its rights
hereunder, the Parties shall thereafter discuss from time to time whether the situation has been
resolved and, accordingly, whether Orion is in a position to resume the supply of Orion Product
pursuant to this Agreement.




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





30.









 








12. COMPETING PRODUCTS 




     12.1 Obligations With Respect to Competing Products



          12.1.1 Beginning on the Effective Date and until the expiration of the last of the Orion
Patent Rights on a country by country basis in the Major Countries, GTX and GTX Affiliates
undertake not to market or sell a Competing Product in such country, excluding those countries of
the Major Countries within the European Union, in which countries GTX and GTX Affiliates undertake
not to market or sell any Competing Product for a period of five (5) years from the Amendment Date.




          12.1.2 However, nothing contained in this Section 12.1 shall be construed as preventing either
Party from conducting research and development activities relating to a Competing Product during
such period or thereafter.




13. PRODUCT ORDERS, SUPPLY AND PAYMENTS 




     13.1 Orion Supply Obligations



          13.1.1 Product Supply. During the Term, Orion shall, subject to the terms of this Section 13,
supply GTX and GTX Affiliates with their requirements of Orion Product. Orion shall supply the
Product in bulk tablet form.




          13.1.2 Product Delivery. Orion shall supply Orion Product to GTX only against receipt of
GTX’s written purchase orders. Except as otherwise provided herein or as otherwise expressly agreed
in writing by the Parties, delivery shall be within ninety (90) days from receipt and confirmation
by Orion of GTX’s purchase order. Orion shall confirm the delivery dates within ten (10) business
days after receipt of GTX’s purchase orders and, subject to the provisions of Section 13.2, Orion
shall use its best reasonable efforts to fill such orders on the requested delivery dates, but
shall in any event fill such orders within ninety (90) days from receipt and confirmation of GTX’s
purchase order. Orion shall deliver Orion Product F.O.B. Espoo, Finland to a carrier designated by
GTX. GTX shall pay shipping costs and shall assume title to and risk of loss for Orion Product
purchased hereunder upon delivery to GTX’s designated carrier.




          13.1.3 Product Shipping Instructions. GTX shall provide Orion with appropriate instructions
for each shipment of Orion Product hereunder designating the desired carrier, destination and
method of transport. If Orion becomes aware that the designated carrier is unable to accept the
desired shipment within the requested delivery period, Orion shall promptly notify GTX and GTX
shall promptly designate another carrier or carriers.




     13.2 Orion Affiliates and Subcontractors. Orion may satisfy its supply obligations under this
Agreement either directly or through any Orion Affiliate, whether located inside or outside GTX
Territory (provided that such Orion Affiliate has a manufacturing site which has received all
required regulatory approvals and that Orion guarantees the performance of such Affiliate), and
such supply by Orion Affiliates shall not be deemed an infringement of GTX’s rights hereunder.



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





31.









 





     13.3 GTX Forecasts



          13.3.1 Rolling Forecasts. Not later than ninety (90) days prior to GTX’s first commercial
order of Orion Product from Orion for GTX’s Product launch anywhere in the GTX Territory, GTX shall
inform Orion in writing of GTX’s bona fide, good faith estimated requirements of Orion Product in
the GTX Territory during the remainder of the calendar year of said Product launch. Thereafter, for
the remainder of the Term, GTX shall provide to Orion by September 30 of each year a purchase
forecast of GTX’s estimated requirements of Orion Product for the fifteen (15) month period
beginning with October 1 of the then current year, allocated for each calendar month of such
period. GTX shall update its purchase estimates to Orion on a monthly basis by indicating by the
end of each month revised estimates or confirming that no revisions are necessary, which shall
provide Orion with GTX’s rolling fifteen (15) month forecasts.




          13.3.2 Excess Quantities. If GTX orders a quantity of Orion Product in excess of one hundred
twenty-five percent (125%) of GTX’s purchase forecast provided two (2) Calendar Quarters prior to
such order, Orion shall deliver the quantity in excess of one hundred twenty-five percent (125%) up
to one hundred fifty percent (150%) of such forecast within one hundred twenty (120) days from
receipt and confirmation of GTX’s purchase order. If GTX orders a quantity of Orion Product in
excess of one hundred fifty percent (150%) of GTX’s purchase forecast provided two (2) Calendar
Quarters prior to such order, Orion shall use commercially reasonable efforts to supply the
quantity in excess of one hundred fifty percent (150%) up to two hundred percent (200%) of such
forecast as soon as practical, but in no event later than one hundred eighty (180) days from
receipt and confirmation of GTX’s purchase order. If GTX orders a quantity of Orion Product in
excess of two hundred percent (200%) of GTX’s purchase forecast provided two (2) Calendar Quarters
prior to such Order, Orion shall use commercially reasonable efforts to supply the quantities in
excess of such forecast as soon as practical.




          13.3.3 Minimum Quantities. Of the amounts of Orion Product indicated by GTX in its rolling
monthly forecasts, GTX shall purchase at least one hundred percent (100%) of its estimated
requirement for Orion Product for the first three (3) months of such forecast, eighty percent (80%)
of its estimated requirement of Orion Product for the fourth, fifth and sixth months of such
forecast, and fifty percent (50%) of its estimated requirement of Orion Product for the seventh,
eighth and ninth months of such forecast. All orders and deliveries of Orion Product shall be in
full batch sizes of Orion Product, as determined by Orion from time to time. Orion shall notify GTX
in writing prior to the date upon which GTX must provide its first commercial order of Orion
Product under this Section 13 of what the size of a full batch of Orion Product is at such time.




     13.4 Prices and Payment



          13.4.1 Commercial Pricing Formula. Orion’s annual price of bulk Orion Product to GTX for
commercial purposes, delivered F.O.B., Espoo, Finland, shall be:




               [ * ]




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





32.









 





          13.4.2 Invoicing and Payment. Orion shall invoice GTX for commercial orders of Orion Product
shipped, and GTX shall pay such invoice within thirty (30) days of receipt.




          13.4.3 Price Changes. GTX may, no more than once per year, request that Orion determine
whether the average cost of the raw materials set forth in Schedule C used to manufacture Product
during the immediately preceding year has, in the aggregate, changed by more than five percent (5%)
of the average cost thereof that applied during the year immediately preceding the date that is one
year earlier than the date of GTX’s request (any such change, a “Significant Cost Change”).
Reasonably promptly following any such request by GTX, Orion shall make such determination and
notify GTX of the result of such determination. Additionally, if Orion determines that a
Significant Cost Change has occurred (other than in response to such a request by GTX), it shall so
notify GTX. If Orion determines that a Significant Cost Change has occurred upon GTX’s request or
upon Orion’s own investigation, then the Parties shall (no more than once annually) adjust the
price to reflect such Significant Cost Change. Such price shall apply to Orion Products purchased
by GTX following the date of Orion’s notice to GTX that a Significant Cost Change has occurred.




     13.5 Resale Prices. GTX, its Affiliates and GTX Unaffiliated Sublicensees shall be free to
set their own resale prices for the Product sold in the GTX Territory.



     13.6 Product Supply for Testing and Registration; Supply of Toremifene.



          13.6.1 Product Supply for Testing and Registration. The supply price for the [ * ] tablet
of bulk Orion Product for clinical trials shall be [ * ] per tablet. Orion shall supply GTX
with such quantities of [ * ] tablets of bulk Product as GTX may require of Orion Product
and/or placebos for GTX’s use in clinical trials referenced in the GTX Preliminary Development and
Registration Plan or the GTX Final Development and Registration Plan. The price for the [ * ]
tablet of bulk Orion Product for clinical trials shall be [ * ] per tablet. Orion shall supply
GTX with such quantities of [ * ] tablets of bulk Product as GTX may require of Orion Product
and/or placebos for GTX’s use in clinical trials referenced in the GTX Preliminary Development and
Registration Plan or the GTX Final Development and Registration Plan. The price for the [ * ]
tablet of bulk Orion Product for clinical trials shall be [ * ] per tablet. Orion shall supply
GTX with such quantities as GTX may require of [ * ] tablets of Orion Product and/or placebos
for GTX’s use in clinical trials referenced in the GTX Preliminary Development and Registration
Plan or the GTX Final Development and Registration Plan. The price for a [ * ] placebo for such
clinical trials shall be [ * ], per tablet. All Orion Product supplied for testing and
registration pursuant to this Section 13.6 shall be provided in bulk packaging.




          13.6.2 Supply of Toremifene.




     For the sole purpose of aiding GTX in its efforts to obtain Regulatory Approval for the
Product for use in the Field in the GTX Territory, Orion shall, during the Term, upon written order
thereof by GTX, provide GTX, free of charge, with up to [ * ] of Toremifene in bulk powder form
(the “Powder”). GTX undertakes to use such Powder only for studies necessary to support Regulatory
Approval for Product for use in the Field. Upon ordering Powder from Orion,



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





33.









 







GTX shall provide Orion with a detailed description of such study(ies) and the expected amount
of Powder needed for said study(ies).



     As consideration for Orion’s agreeing to provide the Powder to GTX, all results, data,
information, inventions, memoranda, reports, discoveries, work products and other results
(including without limitation any patents(s) granted thereon), which are conceived, derived,
reduced to practice, made and/or developed by or on behalf of GTX and arising out of or relating to
the use of the Powder (hereinafter referred to as “Results”) shall be jointly owned by GTX and
Orion such that each party shall have a one-half undivided interest in and to such results, without
a duty of accounting to the other Party. Orion’s interest in the Results, and any patent rights
related thereto, shall be subject to the licenses granted to GTX pursuant to Section 2.1 to the
extent such Results are included in the Orion Patent Rights or Orion Know-How. GTX hereby grants to
Orion an exclusive, royalty-free, worldwide license with the right to grant sublicenses, under
GTX’s joint interest in the Results and any intellectual property rights relating thereto for use
in developing, using, having used, selling, having sold, importing, marketing and distributing
products outside of the Field. Orion hereby grants to GTX an exclusive, royalty-free, worldwide
license, with the right to grant sublicenses, under Orion’s joint interest in the Results and any
intellectual property rights relating thereto, for use in developing, using, having used, selling,
having sold, importing, marketing and distributing products in the Field, to the extent such rights
are not otherwise included in the Orion Patent Rights or Orion Know-How licensed to GTX pursuant to
Section 2.1.1.



     Any use of the Results by GTX other than for the purposes of this Agreement (hereinafter
referred to as “Other Use”), shall not be permitted without the express written consent of Orion,
which Orion may withhold at its sole discretion.



     Without prejudice to the foregoing, the Results shall be deemed both Orion’s and GTX’s
Confidential Information and shall be used and treated for purposes of Section 8 of this Agreement
as Confidential Information of the other Party. GTX shall promptly disclose to Orion all Results
immediately when such Results are available.



     GTX and Orion shall mutually determine whether or not any of the Results provide the basis for
any patentable inventions. If both Orion and GTX consider that patents for any such inventions
involving Results should be sought, then such applications shall, in accordance with what has been
stated herein above, be filed in the Parties’ joint name, and the Parties shall share equally all
costs of filing, prosecuting and maintaining relevant patent applications and patents. The Parties
shall negotiate in good faith on the division of responsibilities with regard to drafting, filing,
prosecuting and maintaining the relevant patent applications and, patents. If the Parties do not
decide that patent application(s) should be filed for any patentable inventions included in the
Results, then the Results shall continue to be treated as Confidential Information of both Parties.



     13.7 Agreement Terms Govern. Except as otherwise agreed in writing by the Parties, the terms
and conditions of this Agreement shall govern Orion and its Affiliates’ sale of Orion Product to
GTX, its Affiliates and GTX Unaffiliated Sublicensees during the Term, notwithstanding any
conflicting terms and conditions set forth in GTX’s forecast, order or




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




34.









 







purchase documents or in Orion’s sale or acceptance documents and any such conflicting terms
are hereby expressly rejected.



     13.8 Price Adjustment for Commercial Supply. It is agreed upon by the Parties that the price
of the [ * ] tablet of Orion Product to GTX shall be reduced below [ * ] based upon
attaining certain milestone purchases of Product as follows: if GTX purchases annually an aggregate
amount of [ * ] of tablet [ * ] the price of the tablet shall be [ * ] per [ * ]
tablet. Similarly, (i) the price to GTX of the [ * ] tablet of Orion Product shall be reduced
if GTX purchases annually [ * ] of the [ * ] tablets such that the price per [ * ]
tablet of Orion Product shall be [ * ] and (ii) the price to GTX of the [ * ] tablet of
Orion Product shall be reduced if GTX purchases annually [ * ] of the [ * ] tablets such
that the price per [ * ] tablet of Orion Product shall be [ * ] . If a price adjustment is
triggered under this Section 13.8, then the adjusted price shall apply to the entire amount of the
relevant tablets purchased during the relevant year. Orion shall within thirty (30) days after the
end of such year, pay to GTX an amount equal to the number of relevant tablets actually purchased
during such year, multiplied by the difference between the price paid by GTX for supply of the
relevant tablets and the lower price that is actually applicable due to the adjustment to be made
pursuant to this Section 13.8.



     13.9 Termination of Product Supply. Orion shall, at its sole discretion, have the right upon
providing twenty-four (24) months prior written notice thereof, to terminate its obligations under
this Section 13 relating to the manufacture and supply of Orion Product and/or Toremifene (pursuant
to Section 13.6.2) in the event that Orion permanently ceases the manufacture of Toremifene and/or
Orion Product. In the event that Orion so terminates such obligations, Orion shall grant GTX a
contingent license under the Orion Patent Rights, Orion Know-How and the Manufacturing Patents to
make and have made Product for use in the Field in the GTX Territory during the Term, with such
license to be exclusive with respect to Products for use in the Field and in the North American
Territory, and non-exclusive for exclusive use in the Field in the ROW Territory. Such license
shall become effective upon GTX’s receipt of notice from Orion under this Section 13.9. Orion shall
during such twenty-four (24) month notice period, and as soon as practically possible after GTX’s
written request, provide GTX with Product Manufacturing Know-How to the extent reasonably necessary
to enable GTX to exercise its back-up manufacturing right pursuant to this Section 13.9, including
without limitation providing up to ten (10) person-days of technology transfer assistance at GTX’s
site of manufacture of Product using Orion personnel skilled in such manufacturing operations, at
no charge to GTX.



14. PRODUCT WARRANTIES AND INDEMNIFICATION 




     14.1 Product Warranties and Limitations



          14.1.1 Orion Warranties. Orion warrants and represents that the Orion Product manufactured by
Orion, its Affiliate(s) or subcontractor(s), as the case may be, and delivered to GTX, its
Affiliate(s) or GTX Unaffiliated Sublicensee(s) hereunder for resale shall (i) from the date of
shipment until the end of the specified shelf-life conform to the Specifications (provided,
however, that Orion Product has after shipment been handled and stored properly and been afforded
sufficient protection against deterioration and damage) and




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





35.









 







shall have been manufactured in accordance with U.S. FDA Good Manufacturing Practices and
equivalent Good Manufacturing Practices in Europe to the extent applicable to Orion, its Affiliates
or subcontractors as the manufacturer(s) of Orion Product, and (ii) be transferred free and clear
of any security interests, liens and encumbrances. It is expressly agree that, except as expressly
provided for in Section 10.2, no representation, warranty, commitment or obligations given, made or
undertaken by Orion in this Agreement shall apply with regard to any Product manufactured by a
party other than Orion, its Affiliates or subcontractors, including without limitation any Product
manufactured by or on behalf of GTX under its stand-by and other manufacturing rights pursuant to
Section 7.6, 13.9, 15.1, 16.3.2, 16.4 or 20.2.2.




          14.1.2 Limitations. Except as otherwise expressly stated herein, no warranties or
representations, express or implied are made or shall be deemed to have been made by Orion, its
Affiliate or subcontractor including without limitation the warranties of fitness for a particular
purpose and merchantability, regarding any Product, including without limitation the Orion Product
and Other Product. Subject to Orion’s warranty and indemnification obligations under this Agreement
for Orion Product, Orion shall have no responsibility or liability for any Product, including
without limitation Orion Product and Other Product manufactured by Orion and/or used, supplied,
marketed, or sold by GTX, its Affiliates or GTX Unaffiliated Sublicensees.




     14.2 Certificate of Analysis. Orion shall furnish GTX with one or more certificates of
analysis for each batch of Orion Product supplied hereunder, in the form required by law in each
country of GTX Territory where the Orion Product is marketed, with shipment of each such batch.



     14.3 Product Inspections




          14.3.1 GTX Inspection and Analysis. GTX shall inspect and analyze a representative sample of
Orion Product from batches supplied by Orion promptly after receipt. If, after inspection, GTX
reasonably believes the shipment does not meet the Specifications, GTX shall notify Orion in
writing within thirty (30) days after GTX’s receipt of any such goods. If GTX does not so notify
Orion, GTX shall be deemed to have waived all claims against Orion for said quantity delivered,
except for any latent defects that could not have been reasonably discovered upon such inspection,
which defects shall be notified by GTX to Orion within fourteen (14) days from discovery of same.
Any claims by GTX regarding goods delivered shall specify in reasonable detail the nature and basis
for the claim and cite relevant Orion lot numbers or other information to enable specific
identification of the goods involved. GTX shall not be required to accept Orion Product having a
shelf-life of less than eighty percent (80%) of the stated expiration dating on the date of
shipment by Orion.




          14.3.2 Orion Response. Orion shall respond to all claims made by GTX on a case-by-case basis
and Orion shall have the right to first inspect any goods involved before being required to take
any action with respect thereto. Orion shall review any such claim of nonconformity made by GTX
within thirty (30) business days of receipt of GTX’s notice under Section 14.3.1 and conduct any
required testing of the goods involved as soon as possible, but in no event later than forty-five
(45) days after receipt thereof, or earlier if the U.S. FDA or any corresponding regulatory
authority in the Territory requires an earlier response from Orion. If such review and testing by
Orion (or testing by an independent laboratory as set forth below)





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





36.









 







confirms that a claimed quantity does not meet the Specifications, then, at Orion’s expense,
GTX shall dispose of or return such quantity involved as Orion shall direct in writing and Orion
shall replace such quantity with conforming goods as soon as possible, but in no event later than
sixty (60) days after testing is completed, which shall be GTX’s sole and exclusive remedy for such
non-conformity. If the Parties fail to agree as to whether a delivered quantity meets the
Specifications, then the Parties shall have the batch in dispute analyzed by a mutually agreed upon
independent testing laboratory located in the country in which Orion Product to which goods relate
is intended for resale, or, if the Parties agree, in Finland. Such laboratory’s determination shall
be deemed final as to any dispute over the Specifications and the nonprevailing Party shall bear
the costs of such independent laboratory’s testing.




     14.4 Product Storage. Each Party shall properly store Orion Product under conditions that
will not adversely affect the quality or normal shelf life thereof.



     14.5 GTX Responsibilities in GTX Territory




          14.5.1 Labeling. GTX shall be responsible for packaging of the Product, and for all labeling,
inserts, packaging and promotional materials and any other materials which accompany, are
distributed, used or referred to in any way by GTX, its Affiliate(s) or GTX Unaffiliated
Sublicensee(s) in connection with the Product and GTX shall ensure that same shall conform to all
legal requirements in each country of the GTX Territory in which the Product is sold. Subject to
applicable legal and regulatory requirements and space limitations, all Product labeling,
packaging, inserts and promotional materials shall indicate that the Product is sold by GTX under
license from Orion. GTX shall, upon written request therefore by Orion, provide Orion with copies
of representative samples of materials which GTX, its Affiliates and GTX Unaffiliated Sublicensees
intend to use in connection with the marketing, promotion and sale of the Product thirty (30) days
prior to their first use thereof, provided that nothing herein or otherwise, including without
limitation any request by Orion to be furnished with such materials or review of same, shall be
construed as Orion assuming any liability or responsibility for such materials or their conformity
to all legal requirements in any country of the GTX Territory in which the Product is sold and such
request and/or review by Orion of such materials shall be without prejudice to the first sentence
of this Section 14.5. GTX, its Affiliates, or GTX Unaffiliated Sublicensee shall register, promote,
market and sell the Product in the GTX Territory only for the indications for which relevant
Regulatory Approvals have been obtained and only in accordance with applicable legal and
governmental authority requirements.




          14.5.2 Notification. GTX shall also be responsible for notifying, reporting or registering
this Agreement or the business relationship created hereby with any government authorities in the
GTX Territory to the extent legally required. Orion shall provide GTX with such assistance as GTX
may reasonably request in connection therewith.




     14.6 Reciprocal Indemnification Provisions



          14.6.1 Orion Indemnification. Orion shall defend, indemnify and hold GTX, its Affiliates, GTX
Unaffiliated Sublicensees, and its and their officers, directors and employees, harmless from and
against any and all liabilities, damages, claims, demands, costs, or expenses (including reasonable
attorneys’ fees) Losses claimed by any Third Party for any property or




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




37.









 




other economic loss or damage or injury or death suffered by it to the extent the same is
determined to have been caused by (A) the negligence, fault, willful wrongdoing or any other act or
omission in relation to the manufacture by Orion, its Affiliates or subcontractor(s) of the Orion
Product, or a material breach of this Agreement by Orion, its Affiliate(s) or Unaffiliated
Sublicensee(s), or (B) or a breach by Orion of the warranties set forth in Section 14.1, except
with respect to each of (A) and (B) to the extent that such Losses are caused by activities for
which GTX must defend, indemnify and hold harmless pursuant to Section 14.6.2.




          14.6.2 GTX Indemnification in GTX Territory. GTX shall defend, indemnify and hold Orion, its
Affiliates, and its and their the officers, directors and employees harmless from and against any
and all Losses claimed by any Third Party for any property or other economic loss or damage, injury
or death suffered by it to the extent the same is determined to have been caused by (A) the
negligence, fault, willful wrongdoing or any other act or omission, or material breach of this
Agreement by GTX, its Affiliates or Unaffiliated Sublicensees or (B) the manufacture, use, sale,
importation, distribution, and/or marketing of the Product in the Field in GTX Territory, including
without limitation any product liability claim for property or other economic loss or damage,
injury or death suffered by a Third Party arising out of or relating to the Product or Other
Product or use thereof, except with respect to each of (A) and (B) to the extent that such Losses
are caused by activities for which Orion must defend, indemnify and hold harmless GTX pursuant to
Section 14.6.1.




     14.7 Conditions for Indemnification. With respect to any indemnification obligations of
either Party to the other Party under this Agreement, the following conditions must be met for such
indemnification obligations to become applicable: (A) the indemnified Party shall notify the
indemnifying Party promptly in writing of any claim which may give rise to an obligation on the
part of the indemnifying Party hereunder; (B) the indemnifying Party shall be allowed to timely
undertake the sole control of the defense of any such action and claim, including all negotiations
for the settlement, or compromise of such claim or action at its sole expense; and (C) the
indemnified Party shall render reasonable assistance, information, cooperation and authority to
permit the indemnifying Party to defend such action, it being agreed that any out-of-pocket
expenses or other expenses incurred by the indemnified Party in rendering the same shall be borne
or reimbursed promptly by the indemnifying Party.



     14.8 Liability Insurance. GTX shall procure and maintain insurance, including product
liability insurance, adequate to cover its obligations hereunder and which are consistent with
normal business practices of prudent companies commercializing products of similar nature that
present similar liability risks. It is understood that such insurance shall not be construed to
create a limit of GTX’s liability with respect to its any of its obligations hereunder, including
without limitation its indemnification and compensation obligations under this Agreement. GTX shall
provide Orion with written evidence of such insurance (including without limitation financial
information that describes the amounts available under such insurance) upon request. This Section
14.8 shall survive the termination expiration of this Agreement for ten (10) years for whatsoever
reason.



15. STANDBY MANUFACTURING RIGHTS 




 




			
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filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





38.









 








     15.1 Inability to Manufacture or Supply. If Orion is unable to supply or manufacture Orion
Product, as ordered pursuant to Sections 13.1.2 and 13.3.2, for ninety (90) or more consecutive
days after the agreed delivery time for any reason, (including but not limited to a Force Majeure
event), save as for reasons arising from acts or omissions of GTX, its Affiliates and/or its
Unaffiliated Sublicensees, including without limitation failure by GTX, its Affiliates and/or its
Unaffiliated Sublicensees to notify Orion of Orion’s failure to deliver Orion Product ordered
pursuant to Sections 13.1.2 and 13.3.2, then GTX may, at its option, responsibility and expense,
elect to manufacture or have a Third Party manufacture Toremifene for use in manufacturing and
selling the Product for use in the Field anywhere in the GTX Territory until such time as Orion can
demonstrate to GTX’s reasonable satisfaction that Orion is capable of resuming the manufacture of
Toremifene and/or Orion Product, as applicable. To the extent necessary to implement such standby
manufacturing rights, Orion hereby grants GTX a contingent license under the Orion Patent Rights,
Orion Know-How and Manufacturing Patents to make and have made Product for use in the Field in the
GTX Territory. Such license shall be exclusive with respect to Products for use in the Field and in
the North American Territory, and nonexclusive for exclusive use in the Field in the ROW Territory,
with such license to become effective only under the circumstances specified in the preceding
sentence. In such case, Orion shall as soon as practically possible provide GTX with Product
Manufacturing Know-How to the extent reasonably necessary to enable GTX to exercise its back-up
manufacturing right pursuant to this Section 15.1, including without limitation providing up to ten
(10) person-days of technology transfer assistance at GTX’s site of manufacture of Product using
Orion personnel skilled in such manufacturing operations, at no charge to GTX. Orion shall promptly
notify GTX in writing of any circumstances rendering it unable to manufacture Product and the
estimated duration of such circumstances. GTX’s standby-manufacturing rights under this Section
15.1 shall be GTX’s sole and exclusive remedy for Orion’s failure to manufacture or have
manufactured Orion Product for supply to GTX under Section 13.



16. MANUFACTURING INSPECTIONS AND CHANGES 




     16.1 Regulatory Inspections. Each Party shall allow representatives of the U.S. FDA and any
other regulatory agency or authority with jurisdiction over the manufacture, marketing and
distribution of the Product to tour and inspect all facilities utilized by such Party in the
manufacture, testing, packaging, storage, and shipment of Product sold under this Agreement, and
shall co-operate with such representatives in every reasonable manner. Each Party shall also
provide the other Party with a copy of any U.S. FDA Form 483 notices of adverse findings,
regulatory letters or similar notifications it receives from any other governmental authority
setting forth adverse findings or non compliance with any applicable laws, regulations or standards
relating to the Product within five (5) days of its own receipt thereof. Each Party shall also
provide the other Party with a copy of its proposed written response to such governmental authority
before submission and shall incorporate any changes thereto which the other Party may reasonably
request.



     16.2 Orion-initiated Manufacturing Changes. Save as for changes required under applicable
laws and regulations or by any competent regulatory or other authority, during the Term, Orion
shall not make any material changes to its manufacturing operations for Toremifene and Orion
Product to be supplied to GTX pursuant to this Agreement, without informing GTX prior to such
changes; provided that if such changes would require GTX to make additional



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





39.









 







filings with regulatory authorities or to seek additional Regulatory Approvals for Orion
Product, then Orion shall not make such change without GTX’s prior written consent, such consent
not to be unreasonably withheld, conditioned or delayed



     16.3 GTX-Initiated Manufacturing Changes



          16.3.1 GTX Request for Manufacturing Changes. Prior to Orion providing GTX with notice
pursuant to Section 13.9, GTX may, from time to time during the Term and as agreed in this Section
16.3, make a written and detailed request for changes in Orion’s manufacturing operations, or the
Specifications, for Toremifene and Orion Product. Such changes that are required and mandatory
under applicable laws and regulations in a Major Country shall be deemed “Required Manufacturing
Changes”, and such changes that are intended to promote quality control/quality assurance, and/or
to achieve greater efficiency or cost savings in the manufacturing process shall be deemed “Other
Manufacturing Changes”.




          16.3.2 Required Manufacturing Changes. Provided that GTX furnishes Orion with evidence of
Required Manufacturing Changes, Orion shall commence the implementation of Required Manufacturing
Changes as soon as practicable, but in no event later than (i) ninety (90) days after receipt of
GTX’s request (or within such other longer time period as may be mutually agreed upon by the
Parties if implementation within ninety (90) days is impossible or reasonably impractical, such
agreement not to be unreasonably withheld, condition or delayed by GTX) or (ii) earlier if required
by the U.S. FDA or any corresponding regulatory authority in a Major Country. If Orion does not
commence the implementation of Required Manufacturing Changes within the time period referenced in
the preceding sentence or does not notify GTX in writing that Orion disputes whether GTX’s
requested changes are Required Manufacturing Changes, then GTX shall have the option to exercise
standby manufacturing rights for Toremifene and Product pursuant to Section 15.1 until such time as
Orion implements such Required Manufacturing Changes. If Orion notifies GTX in writing that Orion
disputes whether GTX’s requested changes are Required Manufacturing Changes, the Parties shall
resolve such dispute by reference to a mutually agreed upon independent Third Party regulatory
expert as soon as possible for a binding determination of whether the requested changes are
Required Manufacturing Changes. If such independent Third Party regulatory expert determines that
GTX’s requested changes are Required Manufacturing Changes, Orion shall implement such changes as
soon as possible. Any modification to the Specifications that is necessary to implement or reflect
a Required Manufacturing Change shall be deemed to be included in the Specifications, and any
Products manufactured thereunder by Orion shall be deemed Orion Products.




          16.3.3 Other Manufacturing Changes. Orion shall give due consideration to making Other
Manufacturing Changes proposed by GTX. Orion shall within sixty (60) days from receipt of GTX’s
written request for Other Manufacturing Changes provide GTX a written response to such request
indicating whether it would be willing to discuss, and as appropriate, negotiate the terms and
conditions under which Orion would be willing to implement such Other Manufacturing Changes.




     16.4 New Dosage Strengths and Formulations. Upon written request by GTX, the Parties shall
meet in person or by teleconference to discuss, and as appropriate, negotiate the



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





40.









 







terms under which Orion would be willing to manufacture and supply to GTX any dosage strengths
or formulations of the Product other than those that are available as an Orion Product as of the
Amendment Date (including without limitation any combination Product containing Toremifene and
another active ingredient) or any Product otherwise having specifications different from Orion
Product Specifications (such Products, collectively “Other Product(s)”), as provided in this
Section 16.4.



     The Parties shall conduct such discussions during a sixty (60) day period following GTX’s
written request setting forth in sufficient detail the changes proposed by GTX, or any mutually
agreed extension of such time period (“Evaluation Period”). If Orion would be willing to
manufacture such Other Product, Orion shall within the Evaluation Period notify GTX of the terms
and conditions under which it would be willing to do so, and the Parties shall negotiate a written
amendment to this Agreement to include the applicable terms and conditions under which Orion would
manufacture such Other Product, including without limitation the supply price of such Other
Product. Upon execution of such amendment, such Other Product shall be deemed to be an Orion
Product. Such negotiation shall be conducted for up to one hundred twenty (120) days following
GTX’s receipt of Orion’s notice of such terms and conditions (“Negotiation Period”). It is
expressly agreed that Orion shall have no obligation to manufacture and supply any Other Product
unless a mutually acceptable definitive written amendment to this Agreement, if any, in relation to
such Other Product is executed by duly authorized representatives of both Parties.



     In the event Orion notifies GTX within the Evaluation Period that it will not be interested in
supplying such Other Product, or the Parties do not amend this Agreement during the Negotiation
Period to specify applicable terms for, or execute another agreement governing, Orion’s supply of
such Other Product for use in the Field, then if GTX has a good faith basis for requiring supply of
such Other Product, including but not limited to its desire to develop a dosage strength of Product
other than one which is in clinical development by or on behalf of GTX as of the Amendment Date and
in which an Orion Product is available, or a formulation of Product that incorporates a new
technology or another active ingredient in order to optimize the pharmacokinetic properties of
Product, improve the competitive position of Product in the market, or to increase the efficiency
or safety of Products, GTX shall have the right to manufacture, or engage a Third Party
subcontractor to manufacture, such Other Product for sale and use in the Field only. GTX shall
exercise such right to manufacture or have manufactured an Other Product for sale and use in the
Field pursuant to this Section 16.4 in good faith only, and not for the purpose of obtaining the
right to manufacture Product by, for example, proposing minor changes to the Product formulation
that do not present a commercially reasonable basis for development. To the extent reasonably
necessary to implement such manufacturing right, Orion hereby grants GTX a contingent license under
Orion’s Patent Rights, Orion Know-How, Manufacturing Patents, and Product Manufacturing Know-How to
make and have made the relevant Other Product for use in the Field in the GTX Territory. Such
license shall be exclusive with respect to Products for use in the Field and in the North American
Territory, and nonexclusive for exclusive use in the Field in the ROW Territory, and shall become
effective only under the circumstances specified in this Section 16.4.



17. PRODUCT RECALLS 




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





41.









 








     17.1 Recall Notification. Each Party shall promptly notify the other Party in writing of any
facts relating to the advisability of the recall, destruction or withholding from the market of the
Product anywhere in the GTX Territory (collectively, “Recall”).



     17.2 Recall Implementation in GTX Territory. If at any time (A) any governmental or
regulatory authority in the GTX Territory issues a request, directive or order for a Recall; (B) a
court of competent jurisdiction orders a Recall in the GTX Territory; or (C) GTX determines,
following consultation with Orion (except in emergency situations in which there is insufficient
time for such consultation), that a Recall in the GTX Territory is necessary or advisable, GTX
shall take all appropriate corrective actions to effect the Recall and Orion shall provide GTX with
such cooperation in connection with the Recall as GTX may reasonably request.



     17.3 Recall Costs and Expenses in GTX Territory. GTX shall bear the costs and expenses of any
Recall in the GTX Territory, provided that Orion shall bear all costs and expenses of any Recall in
the GTX Territory to the extent such Recall is the result of a breach in the warranties set forth
in Section 14.1.



18. ADVERSE DRUG EXPERIENCES 




     18.1 Adverse Events.



               (a) To ensure that all relevant safety information for Toremifene is shared between the
Parties, the following information will be exchanged: (i) GTX will provide to Orion all regulatory
safety updates (e.g. 120-day safety updates, annual reports, post-authorization safety updates)
upon public release thereof concerning the Product; and (ii) Orion will provide to GTX Periodic
Safety Update Reports upon public release thereof prepared in accordance with ICH E2C guidelines
covering Orion’s Toremifene indication for breast cancer. In addition, any safety information which
may negatively affect the benefit-risk ratio of Toremifene products or that may have consequences
regarding the product information (e.g. labeling, data sheets, instruction leaflets) or may require
immediate safety measures to be taken by either Party shall be forwarded to the other Party without
any delay. Each Party is responsible for any regulatory safety reporting requirements with respect
to its own Regulatory Approval applications and regulatory requirements according to applicable
laws, rules and regulations. If the FDA requires that reports of adverse events must be exchanged
between the Parties, and submitted to the FDA in connection with both Parties’ regulatory filings
for Toremifene products, the details of the Parties’ exchange of such information will be modified
accordingly and documented as an Exhibit to this Agreement.



               (b) The intent of Section 18.1(a) is to enable each Party to comply with regulatory
requirements for Toremifene products. If either Party learns that the foregoing exchange of
information is not sufficient for such Party to meet regulatory requirements with respect to
Toremifene products that it has the right to commercialize, it may so note by the other Party.
Promptly thereafter, the Parties shall discuss and agree upon a mutually acceptable modification to
the foregoing procedure that enables the Party providing such notice to conform with such
regulatory requirements with respect to such Toremifene products. Specifically and without
limitation, to the extent regulatory authorities outside of the United States require



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





42.









 







reporting or other obligations with respect to adverse drug experiences in addition to those
stated in Section 18.1(a) above, the Parties shall, promptly after the Amendment Date, meet and
negotiate in good faith mutually agreeable procedures to meet such obligations.



     This Section 18 shall survive the expiration or termination of this Agreement.



19. REPRESENTATIONS AND WARRANTIES 




     19.1 Representations and Warranties of the Parties. Each Party hereby represents and warrants
to the other Party as follows:



               (a) Corporate Status. It is a corporation duly organized and validly existing under the laws
of its state or other jurisdiction of incorporation or formation;



               (b) Authority. It has the power and authority to execute and deliver this Agreement, and to
perform its obligations hereunder;



               (c) No Conflicts. The execution, delivery and performance by it of this Agreement and its
compliance with the terms and provisions hereof does not and will not conflict with or result in a
breach of any of the terms and provisions of or constitute a default under (i) any loan agreement,
guaranty, financing agreement, agreement affecting a product or other agreement or instrument
binding or affecting it or its property; (ii) the provisions of its charter documents or by-laws;
or (iii) any order, whit, injunction or decree of any court or governmental authority entered
against it or by which any of its property is bound;



               (d) No Approvals. Except for the regulatory filings and approvals for the Product referenced
herein, no authorization, consent or approval of any governmental authority or Third Party is
required for the execution, delivery or performance by it of this Agreement, and the execution,
delivery or performance of this Agreement will not violate any law, rule or regulation applicable
to such party;



               (e) Enforceability. This Agreement has been duly authorized, executed and delivered and
constitutes its legal, valid and binding obligation enforceable against it in accordance with its
terms subject, as to enforcement, to bankruptcy, insolvency, reorganization and other laws of
general applicability relating to or affecting creditors’ rights and to the availability of
particular remedies under general equity principles; and



               (f) Compliance with Laws. It shall comply with all applicable local, state, national, regional
and governmental laws and regulations relating to its activities under this Agreement.



               (g) Negative Data or Information. Each Party has, to the best of its management knowledge, no
knowledge of negative data or information regarding the Product, which, to the best of its
reasonable belief, would have a material effect on the regulatory approval process and/or on the
commercialization of the Product in the Field.



20. TERM AND EARLY TERMINATION RIGHTS 




 




			
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filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





43.









 








     20.1 Term. The Term shall be as stated in Section 1.33.



     20.2 Termination for Cause. Either Party shall have the right, without prejudice to any other
rights or remedies available to it, either to terminate this Agreement or the license rights
granted to a Party under this Agreement on a country-by-country basis for cause as described in
this Section 20.2 as follows.



          20.2.1 Bankruptcy. Either Party shall have the right to terminate this Agreement and same
shall terminate upon expiry of a sixty (60) days notice period, if the other Party becomes
insolvent, is adjudged bankrupt, applies for judicial or extra-judicial settlement with its
creditors, makes an assignment for the benefit of its creditors, voluntarily files for bankruptcy
or has a receiver or trustee (or the like) in bankruptcy appointed by reason of its insolvency, or
in the event an involuntary bankruptcy action is filed against the other Party and not dismissed
within ninety (90) days, or if the other Party becomes the subject of liquidation or dissolution
proceedings or otherwise discontinues business.




          20.2.2 Material Breach. If either Party commits a material breach of this Agreement and if the
Party alleged to be in breach of this Agreement fails to (i) cure such breach or (ii) commence bona
fide dispute resolution proceedings under Section 24.2 contesting whether a breach has occurred
and/or whether such breach is a material breach, in either case within sixty (60) days after
receipt of written notice from the Party asserting the breach, then the Party asserting the breach
may terminate this Agreement in its entirety (if such breach is a material breach other than as
specified in Section 11.11.1), or, if such breach is by GTX and is described in Section 6.4.2 or
11.11.1 terminate the license granted to GTX pursuant to Section 2.1 with respect to the Major
Country in relation to which such material breach occurred. If the Agreement is terminated either
in its entirety or with regard to a particular Major Country, as the case may be, then:




     if GTX is the breaching Party, then GTX shall grant to Orion a nonexclusive, royalty-bearing
license, with the right to grant sublicenses, under the GTX Patent Rights, the Trademark and the
GTX Know-How to make have made, use, sell, offer for sale, market and promote, and import Products
in the country(ies) in which GTX’s license terminates (if such breach is a material breach
described in Section 6.4.2) or, for any other material breach, throughout the GTX Territory; or



     if Orion is the breaching Party, then the license granted to GTX shall be expanded to include
a license under the Orion Patent Rights, Orion Know-How, and Manufacturing Patents to make and have
made Products for use in the Field in the GTX Territory during the Term, with such license to be
exclusive with respect to Products for use in the Field and in the North American Territory, and
nonexclusive for exclusive use in the Field in the ROW Territory, and Orion shall as soon as
practically possible provide GTX with Product Manufacturing Know-How to the extent reasonably
necessary to enable GTX to exercise its manufacturing right pursuant to this Section, including
without limitation providing up to ten (10) person-days of technology transfer assistance at GTX’s
site of Manufacture or Product using Orion personnel skilled in such manufacturing operations, at
no charge to GTX.



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




44.









 





     If a non-breaching Party obtains a license under this Section 20.2.2 above, it shall pay to
the other Party a running royalty equal to [ * ] of such non-breaching Party’s Net Sales of
Product in the territory in which such license applies. Furthermore, if GTX is the breaching Party,
GTX shall promptly transfer to Orion, at GTX’s expense, all Regulatory Approvals and registration
filings for the Product in the territory in which Orion obtains such license, together with such
documentation, information and data in its possession as Orion may need for regulatory compliance
in the course of exercising its rights in such territory with respect to Product.



     20.3 Termination by Mutual Agreement. The Parties may terminate this Agreement at any time by
drafting and executing a mutually acceptable written agreement. The written agreement shall specify
the consequences of such termination.



     20.4 Other Termination by Orion



          20.4.1 Orion shall have the right to terminate this Agreement upon thirty (30) days prior
written notice to GTX if any business entity which is a direct competitor of Orion for Toremifene
should any time during the Term acquire control over the business affairs of GTX by purchase or
acquisition of a fifty percent (50%) or greater interest in GTX’s issued and outstanding stock, all
or substantially all of GTX’s assets, or the GTX business unit or division dealing with the
Product. If Orion after the thirty (30) days from receipt of notification (such notification to be
furnished by GTX to Orion at the latest by such purchase or acquisition becoming public knowledge),
does not exercise its rights to terminate this Agreement, Orion shall irrevocably lose and forfeit
such right.




     20.5 Other Termination by GTX



          20.5.1 Change of Control of Orion. GTX shall have the right to terminate this Agreement upon
thirty (30) days prior written notice to Orion if any business entity which is a direct competitor
of GTX for Toremifene for use in the Field should any time during the Term acquire control over the
business affairs of Orion by purchase or acquisition of a fifty percent (50%) or greater interest
in Orion’s issued and outstanding stock, all or substantially all of Orion’s assets, or the Orion
business unit or division dealing with the Product. If GTX after the thirty (30) days from receipt
of notification, such notification to be furnished by Orion to GTX at the latest by such purchase
or acquisition becoming public knowledge, does not exercise its rights to terminate this Agreement,
GTX shall irrevocably lose and forfeit such right.




          20.5.2 Safety or Efficacy. If at any time during the Term: (i) GTX decides not to file an
application for Regulatory Approval in any country or decides to withdraw such application due to
documented adverse reactions or other safety issues with the Product or the Product’s lack of
efficacy or limited efficacy (collectively, “Safety or Efficacy Issues”); (ii) GTX’s application(s)
for Regulatory Approval in any country is rejected due to Safety or Efficacy Issues; (iii) GTX’s
application(s) for Regulatory Approval in any country is subsequently withdrawn because of Safety
or Efficacy Issues; or (iv) the Product is withdrawn or recalled from the market in any country
because of Safety or Efficacy Issues, then GTX may, at its option, terminate this Agreement with
respect to such country upon thirty (30) days prior written notice to Orion. GTX must exercise this
right of termination within the later of




 




			
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filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





45.









 







(a) sixty (60) days of the occurrence of the event giving rise to such right or (b) thirty
(30) days of GTX’s last meeting, if any, with the relevant regulatory authorities, provided that
GTX uses reasonable diligence to schedule such meeting and that Orion is providing reasonable
co-operation to GTX in connection with such meeting. GTX may, at its option, exercise its right of
termination under this Section 20.5.2 on a country-by-country basis, and, if GTX does so, GTX’s
termination notice shall specify the country or countries of the GTX Territory affected.




     20.6 Effect of Termination. Termination or expiration of this Agreement through any means and
for any reason shall not relieve the Parties of any obligations accruing prior thereto and shall be
without prejudice to the rights and remedies of either Party with respect to any prior breach of
any of the provisions of this Agreement.



21. NOTICES 




     21.1 Manner of Giving Notices. All notices required or permitted in connection with this
Agreement shall be writing and may be given by personal delivery, prepaid registered or certified
airmail letter, courier, facsimile, addressed to the Party to receive the same at its address set
forth below, or to such other address as it shall later designate by like notice to the other
Party. Notice of termination of this Agreement if given by facsimile shall be confirmed by prepaid
registered or certified airmail letter dated and posted within twenty-four (24) hours. The
effective date of receipt of any notice if served by facsimile shall be deemed the first business
day in the city of destination following the transmission or dispatch thereof and, if served by
courier shall deemed the second business day in the city of destination following the dispatch
thereof unless earlier received. Notice by personal delivery shall be effective as of the date of
such delivery.



     21.2 Addresses for Notices


Notices to Orion shall be sent to:



Orion Corporation

Orion Pharma

Attn: President of Orion Pharma

Orionintie 1, P.O. Box 65

FIN-02101 Espoo

Finland

Facsimile: 358-9-429-3044



With a copy to:



Orion Corporation

Orion Pharma

Attn: Legal Counsel

Orionintie 1, P.O. Box 65

FIN-02101 Espoo

Finland

Facsimile: 358-9-429-4088




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





46.









 







Notices to GTX shall be sent to:



GTx, Inc.

Attn: President, with a copy to the General Counsel

3 North Dunlap Avenue,

Van Vleet Building, Third Floor

Memphis, Tennessee 38163

U.S.A.

Telephone: 1-901-523-9700 x107

Facsimile: 1-901-523-9772



Cooley Godward LLP

Five Palo Alto Square

3000 El Camino Real

Palo Alto, CA 94306-2155



Attention: Robert Jones, Esq.

Telephone: (650) 843-5034

Facsimile: (650) 849-7400




22. INTEGRATION 




     This Agreement represents the entire Agreement between the Parties relating to the subject
matter hereof and supersedes all prior arrangements, understandings, correspondence, notes, minutes
and agreements between the Parties (or their predecessors in interest) whether written or oral. No
supplement, modification or amendment of this Agreement shall be binding unless executed by the
Parties in writing and signed by the duly authorized representatives of both Parties.



23. ASSIGNMENT 




     Neither Party may assign this Agreement or any of its rights hereunder, nor delegate any of
its duties or obligations hereunder, to any Third Party without the prior written consent of the
other Party, except to an Affiliate in accordance with the terms of this Agreement, in which case
notification thereof shall be provided to the other Party no later than thirty (30) days prior to
such assignment to an Affiliate. Neither Party shall unreasonably withhold its consent which shall
be provided within thirty (30) days, to such contemplated assignment if such contemplated
assignment is in connection with the sale by either Party of all or substantially all of its assets
to a Third Party. Any assignment of this Agreement to an Affiliate of the assigning Party shall not
relieve the assigning Party of its responsibilities and obligations hereunder.



24. GOVERNING LAW AND DISPUTE RESOLUTION 




     24.1 Governing Law. This Agreement, including the validity, construction, interpretation and
performance thereof, shall be governed entirely by the laws of Sweden. It is the specific intent
and agreement of the Parties that the United Nations Convention on the International Sale of Goods
shall not apply to this Agreement.



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




47.









 





     24.2 Dispute Resolution. All disputes arising out of or in connection with this Agreement
(except those involving actions commenced by or involving Third Parties and affecting or involving
only one of the Parties) shall be resolved with the following mechanism:



          24.2.1 Attempted Amicable Resolution. The Parties shall promptly give each other written
notice of any disputes requiring resolution hereunder, which written notice shall specify the
Section(s) of this Agreement the other Party is alleged to have breached and shall briefly state
the initiating Party’s claims, and the Parties shall use reasonable efforts to resolve any such
disputes in an amicable manner.




     Any disputes arising in connection with this Agreement which cannot be resolved in an amicable
manner by representatives of the Parties shall be referred, not later than thirty (30) days after
initiation of dispute resolution proceedings under this Section 24.2.1, to the following corporate
officers of the Parties for resolution:



     For GTX: President and Chief Executive Officer (or his or her designee)



     For Orion: President of Orion-Pharma (or his or her designee)



     Such officers (or their designees) shall attempt to resolve the dispute and shall communicate
with each other by facsimile or telephone or in personal meetings in an effort to resolve the
dispute.



          24.2.2 Arbitration. Any disputes (excluding any dispute, controversy or claim arising out of
or relating to the validity, enforceability, scope or infringement of patent or trademark rights)
arising in connection with this Agreement which cannot be resolved by the Parties within forty-five
(45) days after initiation of dispute resolution proceedings under Section 24.2.1 shall be finally
settled by binding arbitration under the Rules of the Arbitration Institute of the Stockholm
Chamber of Commerce, Stockholm, Sweden in accordance with said Rules then in effect with
proceedings to be held in Stockholm, Sweden in the English language. Reasonable submission of
evidence shall be permitted in any such proceeding to the extent permitted under and consistent
with such Rules. Judgment upon any award rendered by the arbitrator(s) in such proceedings may be
issued and enforced by any court having competent jurisdiction. Any disputes arising out of or
relating to the validity, enforceability, scope or infringement of patent or trademark rights shall
be submitted for resolution by a court of competent jurisdiction.




     24.3 Effect of Commencing Dispute Resolution. If either Party in good faith commences dispute
resolution proceedings under Section 24.2, (A) any applicable notice periods or cure periods
hereunder (including but not limited to the periods referenced in Sections 20.2 and 20.4) shall be
temporarily suspended pending the outcome of such dispute resolution proceedings and (B) the
non-breaching Party may, at its option, pay any amounts payable to the other Party that are in
dispute into an interest-bearing escrow account pending the outcome of such dispute resolution
proceedings.



25. LIMITATION OF DAMAGES 




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




48.









 








     Except for indirect damages resulting from breach of Section 8, in no event shall either Party
be liable to the other Party for any indirect, consequential or punitive damages in connection with
the performance of this Agreement or any breach of this Agreement (excluding such damages payable
to a Third Party which are subject to the indemnification obligations of the Parties set forth in
this Agreement.



26. FORCE MAJEURE 




     Neither Party shall be held in breach of this Agreement for failure to perform any of its
obligations hereunder to the extent and for the time period such performance is prevented in whole
or in part by reason of any Force Majeure event, including but not limited to industrial disputes,
strikes, lockouts, riots, mobs, fires, floods, and other natural disasters and Acts of God, wars
declared or undeclared, civil strife, embargo, delays in delivery or defects or shortages of raw
materials from suppliers, loss or breakdown of any production equipment, losses or shortage of
power, damage to or loss of goods in transit, currency restrictions, or events caused by reason of
laws, regulations or orders by any government, governmental agency or instrumentality or by any
other supervening unforeseeable circumstances whatsoever beyond the control of the Party so
affected. The Party so affected shall (A) give prompt written notice to the other Party of the
nature and date of commencement of the Force Majeure event and its expected duration and (B) use
its reasonable efforts to avoid or remove the Force Majeure event as soon as possible to the extent
it is so able to do.



27. RELATIONSHIP OF PARTIES 




     The relationship of the Parties under this Agreement is that of independent contractors.
Nothing contained in this Agreement shall be construed so as to constitute the Parties as partners,
joint venturers or agents of the other. Neither Party has any express or implied right or authority
under this Agreement to assume or create any obligations or make any warranties and representations
on behalf of or in the name of the other Party, or to bind the other Party to any contract,
agreement or undertaking with any Third Party, and no conduct of the Parties pursuant to the terms
of this Agreement shall be deemed to establish such right or authority. Neither Party shall make
any representation to Third Parties that the relationship created hereby constitutes a partnership,
joint venture or agency relationship.



28. SEVERABILITY 




     In case one or more of the provisions contained in this Agreement shall, for any reason, be
held invalid, illegal or unenforceable in any respect, such invalidity, illegality or
unenforceability shall not affect any other provisions of this Agreement, but this Agreement shall
be construed by limiting such invalid, illegal or unenforceable provision, if such is not possible,
by deleting such provision from this Agreement.



29. NON-WAIVER 




     The failure by either Party at any time to enforce any of the terms or provisions or
conditions of this Agreement or exercise any right hereunder shall not constitute a waiver of the
same or affect that Party’s rights thereafter to enforce or exercise the same. No waiver of any of



 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





49.









 







the provisions of this Agreement shall be deemed binding unless executed in writing by the
Party to be bound by it.



30. HEADINGS 




     The headings in this Agreement are for convenience of reference only and shall not be used in
the interpretation of any provisions hereof.



31. GOVERNING LANGUAGE 




     The English language version of this Agreement shall be controlling in all respects regardless
of whether any translations into any other languages are made.



32. EXECUTION 




     This Agreement shall be executed by the Parties in two (2) original counterparts, one (1)
original counterpart being retained by each Party and either of which shall be deemed sufficient to
prove the existence and terms and conditions hereof. This Agreement may be executed by the Parties
by the exchange of facsimile signature pages, with signed original counterparts of the Agreement to
be exchanged by the Parties promptly thereafter.



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



	 	 	 	 	 	 	 
	Orion Corporation	 	GTx, Inc.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Jyrki Mattila
	 	By:
	 	/s/ Mitchell S. Steiner MD
	 

	 	 
	 	 	 	 
	 

	 	Jyrki Mattila
	 	 	 	Mitchell Steiner, M.D.
	 
	 	 	 	 	 	 
	Title:

	 	President
	 	Title:
	 	Vice-Chairman and CEO
	 

	 	Orion Corporation Orion Pharma
	 	 	 	GTx, Inc.
	 
	 	 	 	 	 	 
	By:

	 	/s/ Timo Lappalainen
	 	By:
	 	/s/ Marc Hanover
	 

	 	 
	 	 	 	 
	 

	 	Timo Lappalainen
	 	 	 	Marc Hanover
	 
	 	 	 	 	 	 
	Title:

	 	Senior Vice President
	 	Title:
	 	President and COO
	 

	 	Business Development & Finance
	 	 	 	GTx, Inc.
	 

	 	Orion Corporation Orion Pharma	 	 	 	 






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





50.









 





SCHEDULE A: PART I




	 	 	 	 	 	 	 	 	 	 	 	 	 
	COUNTRY/JURISDICTION	 	TITLE	 	INVENTORS	 	PATENT NO.	 	ISSUE DATE	 	STATUS
	1. UNITED STATES

	 	METHOD FOR

CHEMOPREVENTION OF PROSTATE CANCER
	 	1. MITCHELLS S.
STENIER


2. SHARAN RAGHAW
	 	 	6,265,448	 	 	July 24, 2001
	 	Issued






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





1.









 





SCHEDULE A: PART II




APPLICATIONS FILED IN THE UNITED STATES




[ * ] 




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





2.









 








APPLICATIONS FILED IN FOREIGN JURISDICTIONS




[ * ] 





 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





3.









 








SCHEDULE B: PART I. ORION PATENTS





			
	TITLE:	 	Novel Alkane and Alkene Derivatives and their Preparation and Use (Toremifene)





	 	 	 	 	 	 	 	 	 
	Country	 	 	 	 	Patent No.	 	Expiry
	 
	AU

	 	Australia
	 	 	556608	 	 	May 25, 2008*
	BG

	 	Bulgaria
	 	 	98379	 	 	May 20, 2003
	CA

	 	Canada
	 	 	1185977	 	 	April 23, 2002
	DK

	 	Denmark
	 	 	170927	 	 	December 21, 2003*
	EP

	 	Europe
	 	 	95875	 	 	December 21, 2003*
	CH

	 	Switzerland
	 	 	95875	 	 	May 19, 2008*
	IT

	 	Italy
	 	 	95875	 	 	February 14, 2008*
	SE

	 	Sweden
	 	 	95875	 	 	May 20, 2008*
	FI

	 	Finland
	 	 	77839	 	 	December 21, 2003*
	HK

	 	Hong Kong
	 	 	83/89	 	 	May 20, 2003
	HU

	 	Hungary
	 	 	193536	 	 	May 26, 2003
	HU

	 	Hungary
	 	 	200742	 	 	May 26, 2003
	IE

	 	Ireland
	 	 	55023	 	 	December 21, 2003*
	IL

	 	Israel
	 	 	68784	 	 	May 25, 2003
	JP

	 	Japan
	 	 	2105540	 	 	May 25, 2003
	JP

	 	Japan
	 	 	1739006	 	 	June 29, 2005*
	JP

	 	Japan
	 	 	1959197	 	 	May 25, 2003
	JP

	 	Japan
	 	 	1867986	 	 	May 25, 2003
	LV

	 	Latvia
	 	 	5066	 	 	May 26, 2003
	NO

	 	Norway
	 	 	156164	 	 	December 21, 2003*
	NZ

	 	New Zealand
	 	 	204349	 	 	May 25, 2003
	SG

	 	Singapore
	 	 	654/88	 	 	May 20, 2003
	SU

	 	Russia
	 	 	1508955	 	 	May 26, 2003
	US

	 	USA
	 	 	4696949	 	 	September 29, 2009*
	US

	 	USA
	 	 	5491173	 	 	September 29, 2004
	US

	 	USA
	 	 	4996225	 	 	February 17, 2008
	ZA

	 	South Africa
	 	 	833803	 	 	May 25, 2003







			
	EP =	 	Germany, Belgium, Austria, Italy, Sweden, Netherlands, Switzerland, Liechtenstein, Luxembourg, Great Britain, France







 




			
	*	 	patent term extension




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





1.









 










SCHEDULE B: PART II. ORION PATENT APPLICATIONS




TITLE: [ * ]




	 	 	 	 	 
	Country	 	 	 	Patent No.
	 
	CN

	 	China
	 	[ * ]
	RO

	 	Romania
	 	[ * ]








 




			
	*	 	Administrative protection based on [ * ]
	 
	**	 	Pipe-line protection based on [ * ]




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





2.









 










SCHEDULE C: SPECIFICATIONS




Specifications for [ * ] tablets




	 	 	 	 	 	 	 
	TEST	 	SPECIFICATION
	 

	 	[ * ]
	 	[ * ]
	 	[ * ]
	CHARACTERS
	 	 	 	 	 	 
	Colour

	 	[ * ]
	 	[ * ]
	 	[ * ]
	Shape

	 	[ * ]
	 	[ * ]
	 	[ * ]
	Score

	 	[ * ]
	 	[ * ]
	 	[ * ]
	Code

	 	[ * ]
	 	[ * ]
	 	[ * ]
	Coating

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]
	 	 	 	 	 	 
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]
	 	 	 	 	 	 
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]
	 	 	 	 	 	 
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]
	[ * ]

	 	[ * ]
	 	[ * ]
	 	[ * ]






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





3.









 






SCHEDULE D: GTS’S MSR OBLIGATION




(TO BE COMPLETED PURSUANT TO SECTION 6.1.1)




 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





4.









 





SCHEDULE E: ORION PRODUCT APPROVALS



REGISTRATION STATUS 27.9.2001

ORION PHARMA




Status: Approved, Pending

Submission types: Marketing authorisations

(2 PAGES)




	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	Decision	 	 	 	 
	Sent Date	 	Appl. Date	 	Product	 	Country	 	Date	 	Decision	 	M.A. holder
	N=39
	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	[ * ]

	 	[ * ]	 	 	[ * ]
	 	[ * ]
	 	 	 	 	[ * ]
	 	[ * ]
	[ * ]

	 	 	 	 	[ * ]
	 	[ * ]
	 	 	 	 	[ * ]
	 	[ * ]
	[ * ]

	 	 	 	 	[ * ]
	 	[ * ]
	 	 	 	 	[ * ]
	 	[ * ]
	[ * ]

	 	 	 	 	[ * ]
	 	[ * ]
	 	 	 	 	[ * ]
	 	[ * ]
	[ * ]

	 	 	 	 	[ * ]
	 	[ * ]
	 	 	 	 	[ * ]
	 	[ * ]
	[ * ]

	 	 	 	 	[ * ]
	 	[ * ]
	 	 	 	 	[ * ]
	 	[ * ]
	30.12.87

	 	30.12.87	 	 	Fareston 20 mg tablet
	 	Finland
	 	21.12.88	 	 	Approved
	 	Orion-yhtyma Oy Farmos
	27.12.88

	 	 	 	 	Fareston 60 mg tablet
	 	Russia
	 	12.12.89	 	 	Approved
	 	Orion Corporation
	27.12.88

	 	 	 	 	Fareston 20 mg tablet
	 	Russia
	 	12.12.89	 	 	Approved
	 	Orion Corporation
	26.02.93

	 	 	 	 	Fareston 60 mg tablet
	 	Latvia
	 	20.05.93	 	 	Approved
	 	Orion-yhtyma Oy Farmos
	26.02.93

	 	 	 	 	Fareston 20 mg tablet
	 	Latvia
	 	20.05.93	 	 	Approved
	 	Orion-yhtyma Oy Farmos
	26.05.92

	 	 	 	 	Fareston 60 mg tablet
	 	Norway
	 	31.07.95	 	 	Approved
	 	Orion Corporation
	10.11.93

	 	 	 	 	Fareston 60 mg tablet
	 	Ukraine
	 	02.02.96	 	 	Approved
	 	Orion Corporation
	10.11.93

	 	 	 	 	Fareston 20 mg tablet
	 	Ukraine
	 	02.02.96	 	 	Approved
	 	Orion Corporation
	14.11.94

	 	30.11.94	 	 	Fareston 60 mg tablet
	 	Sweden
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	14.11.94

	 	30.11.94	 	 	Fareston 60 mg tablet
	 	Finland
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	30.11.94	 	 	Fareston 60 mg tablet
	 	United Kingdom
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	30.11.94	 	 	Fareston 60 mg tablet
	 	Spain
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	30.11.94	 	 	Fareston 60 mg tablet
	 	Portugal
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	29.11.94	 	 	Fareston 60 mg tablet
	 	Netherlands
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	29.11.94	 	 	Fareston 60 mg tablet
	 	Luxembourg
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	28.11.94	 	 	Fareston 60 mg tablet
	 	Italy
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	29.11.94	 	 	Fareston 60 mg tablet
	 	Ireland
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	01.12.94	 	 	Fareston 60 mg tablet
	 	Greece
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	28.11.94	 	 	Fareston 60 mg tablet
	 	Germany
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	30.11.94	 	 	Fareston 60 mg tablet
	 	France
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	30.11.94	 	 	Fareston 60 mg tablet
	 	Belgium
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	17.11.92

	 	 	 	 	Fareston 60 mg tablet
	 	Austria
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	27.11.94

	 	 	 	 	Fareston 60 mg tablet
	 	Denmark
	 	14.02.96	 	 	Approved
	 	Orion Corporation
	31.03.96

	 	 	 	 	Fareston 60 mg tablet
	 	Uzbekistan
	 	16.09.96	 	 	Approved
	 	Orion Corporation
	31.03.96

	 	 	 	 	Fareston 20 mg tablet
	 	Uzbekistan
	 	16.09.96	 	 	Approved
	 	Orion Corporation
	19.12.94

	 	03.01.95	 	 	Fareston 60 mg tablet
	 	United States of America
	 	29.05.97	 	 	Approved
	 	Orion Corporation
	10.04.95

	 	15.07.96	 	 	Fareston 60 mg tablet
	 	Hungary
	 	14.01.98	 	 	Approved
	 	Orion Corporation






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





5.









 






	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	Decision	 	 	 	 
	Sent Date	 	Appl. Date	 	Product	 	Country	 	 	Date	 	Decision	 	M.A. holder
	01.08.97

	 	01.08..97	 	 	Fareston 60 mg tablet
	 	Cyprus
	 	 	23.04.98	 	 	Approved
	 	Orion Corporation
	10.07.96

	 	 	 	 	Fareston 60 mg tablet
	 	Taiwan, R.O.C.
	 	 	29.09.98	 	 	Approved
	 	Orion Corporation
	31.03.95

	 	 	 	 	Fareston 60 mg tablet
	 	Dominican Republic
	 	 	29.12.98	 	 	Approved
	 	Orion Corporation
	10.11.95

	 	26.04.96	 	 	Fareston 60 mg tablet
	 	China
	 	 	13.02.99	 	 	Approved
	 	Orion Corporation
	30.07.01

	 	 	 	 	Fareston 60 mg tablet
	 	Georgia
	 	 	30.07.01	 	 	Approved
	 	Orion Corporation
	30.07.01

	 	 	 	 	Fareston 20 mg tablet
	 	Georgia
	 	 	30.07.01	 	 	Approved
	 	Orion Corporation







 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





6.









 








TOREMIFENE LICENSE AND SUPPLY AGREEMENT




BY AND BETWEEN




ORION CORPORATION




Espoo, Finland




And




GTX INC.,




Tennessee, U.S.A.






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




 









 





Table of Contents




	 	 	 	 	 
	 	 	Page
	1. DEFINITIONS
	 	 	1	 
	1.1 “Affiliate”
	 	 	1	 
	1.2 “Annual Net Sales”
	 	 	1	 
	1.3 “Calendar Quarter”
	 	 	1	 
	1.4 “Competing Product”
	 	 	1	 
	1.5 “DMF”
	 	 	2	 
	1.6 “Field”
	 	 	2	 
	1.7 “First Commercial Sale”
	 	 	2	 
	1.8 “Generic Product”
	 	 	2	 
	1.9 “GTX Final Development and Registration Plan”
	 	 	2	 
	1.10 “GTX Know-How”
	 	 	2	 
	1.11 “GTX Patents”
	 	 	2	 
	1.12 “GTX Patent Applications”
	 	 	2	 
	1.13 “GTX Patent Rights”
	 	 	3	 
	1.14 “GTX Preliminary Development and Registration Plan”
	 	 	3	 
	1.15 “GTX Territory”
	 	 	3	 
	1.16 “GTX Unaffiliated Sublicensee”
	 	 	3	 
	1.17 “Major Country”
	 	 	3	 
	1.18 “Manufacturing Patents”
	 	 	3	 
	1.19 “Net Sales”
	 	 	3	 
	1.20 “North American Territory”
	 	 	3	 
	1.21 “Orion Know-How”
	 	 	3	 
	1.22 “Orion Patents”
	 	 	4	 
	1.23 “Orion Patent Applications”
	 	 	4	 
	1.24 “Orion Patent Rights”
	 	 	4	 
	1.25 “Orion Product”
	 	 	4	 
	1.26 “Orion Unaffiliated Sublicensee”
	 	 	4	 
	1.27 “Premium”
	 	 	4	 
	1.28 “Product”
	 	 	5	 






 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





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Table of Contents
(CONTINUED)





	 	 	 	 	 
	 	 	Page
	1.29 “Regulatory Approval”
	 	 	5	 
	1.30 “ROW Territory”
	 	 	5	 
	1.31 “Sales of Generic Product”
	 	 	5	 
	1.32 “Specifications”
	 	 	5	 
	1.33 “Term”
	 	 	5	 
	1.34 “Third Party”
	 	 	5	 
	1.35 “Toremifene”
	 	 	5	 
	1.36 “Trademarks”
	 	 	5	 
	1.37 “U.S. FDA”
	 	 	5	 
	1.38 “U.S. IND”
	 	 	5	 
	1.39 “U.S. NDA”
	 	 	5	 
	1.40 “Upfront and Milestone Income”
	 	 	6	 
	1.41 “Valid Claim”
	 	 	6	 
	2. GRANT AND SCOPE OF RIGHTS GRANTED
	 	 	6	 
	2.1 Orion Grants to GTX
	 	 	6	 
	2.2 No Implied Licenses
	 	 	10	 
	2.3 United States Government Rights
	 	 	10	 
	2.4 Orion’s Right of First Negotiation
	 	 	11	 
	2.5 Use of Toremifene by GTX for Research
	 	 	11	 
	2.6 Prohibited Actions
	 	 	12	 
	3. PAYMENTS
	 	 	12	 
	3.1 Types of Payments
	 	 	12	 
	3.2 Non-Refundability
	 	 	13	 
	3.3 Royalty Reports and Payments
	 	 	14	 
	3.4 Currency
	 	 	14	 
	3.5 No Royalties Payable Between Affiliates
	 	 	14	 
	3.6 No Multiple Royalties
	 	 	14	 
	4. LIAISON
	 	 	14	 
	5. PAYMENT, RECORD KEEPING AND AUDIT RIGHTS
	 	 	14	 







 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




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Table of Contents
(CONTINUED)





	 	 	 	 	 
	 	 	Page
	5.1 Method of Payment
	 	 	14	 
	5.2 Late Payments
	 	 	15	 
	5.3 Record Keeping and Audit Rights
	 	 	15	 
	6. GTX PRODUCT MARKETING AND SALES ACTIVITIES
	 	 	15	 
	6.1 Minimum Sales Requirements for USA
	 	 	15	 
	6.2 No Minimum Sales Requirements Outside of USA
	 	 	16	 
	6.3 Marketing and Sales Efforts in the Major Countries
	 	 	16	 
	6.4 Product Launch
	 	 	18	 
	6.5 Marketing Costs and Expenses
	 	 	18	 
	6.6 Marketing Plans and Reports
	 	 	18	 
	7. GTX PRODUCT DEVELOPMENT AND REGISTRATIONS
	 	 	19	 
	7.1 GTX Development and Registration Activities
	 	 	19	 
	7.2 Development and Registration Costs
	 	 	20	 
	7.3 GTX Development and Registration Plan
	 	 	20	 
	7.4 Orion Documentation and Data
	 	 	21	 
	7.5 GTX Registration and Marketing Approval Applications
	 	 	22	 
	7.6 Failure to File or Extend
	 	 	22	 
	7.7 Reimbursement of Orion Costs
	 	 	23	 
	8. CONFIDENTIALITY AND PUBLICITY
	 	 	23	 
	8.1 Confidentiality Obligation
	 	 	23	 
	8.2 Permitted Disclosures
	 	 	23	 
	8.3 Confidential Information
	 	 	23	 
	8.4 Duration of Confidentiality Obligation
	 	 	24	 
	8.5 Publicity and Announcements
	 	 	24	 
	9. TRADEMARKS
	 	 	25	 
	9.1 Use of Trademarks
	 	 	25	 
	9.2 Trademark Filing and Maintenance
	 	 	25	 
	9.3 Worldwide Trademark Enforcement
	 	 	25	 
	10. PATENT OWNERSHIP AND WARRANTIES
	 	 	25	 







 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




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Table of Contents
(CONTINUED)





	 	 	 	 	 
	 	 	Page
	10.1 Patent Ownership
	 	 	25	 
	10.2 Orion Patent Warranties
	 	 	25	 
	10.3 GTX Patent Warranties
	 	 	26	 
	11. PATENT PROSECUTION AND INFRINGEMENT
	 	 	26	 
	11.1 Orion Patent Filing and Prosecution
	 	 	26	 
	11.2 GTX Patent Filing and Prosecution
	 	 	26	 
	11.3 Notification of Infringement
	 	 	26	 
	11.4 Infringement of Third Parties Rights by Orion
	 	 	27	 
	11.5 Infringement of Third Parties Rights by GTX
	 	 	27	 
	11.6 Infringement Indemnification
	 	 	27	 
	11.7 Termination for Infringement of Third Party Rights
	 	 	28	 
	11.8 Third Party Infringement of Orion Patent Rights
	 	 	28	 
	11.9 Third Party Infringement of GTX Patent Rights and Trademark
	 	 	29	 
	11.10 Mutual Cooperation
	 	 	29	 
	11.11 Patent Challenges
	 	 	29	 
	11.12 Activities During Infringement Litigation
	 	 	30	 
	12. COMPETING PRODUCTS
	 	 	31	 
	12.1 Obligations With Respect to Competing Products
	 	 	31	 
	13. PRODUCT ORDERS, SUPPLY AND PAYMENTS
	 	 	31	 
	13.1 Orion Supply Obligations
	 	 	31	 
	13.2 Orion Affiliates and Subcontractors
	 	 	32	 
	13.3 GTX Forecasts
	 	 	32	 
	13.4 Prices and Payment
	 	 	33	 
	13.5 Resale Prices
	 	 	33	 
	13.6 Product Supply for Testing and Registration; Supply of Toremifene
	 	 	33	 
	13.7 Agreement Terms Govern
	 	 	35	 
	13.8 Price Adjustment for Commercial Supply
	 	 	35	 
	13.9 Termination of Product Supply
	 	 	35	 
	14. PRODUCT WARRANTIES AND INDEMNIFICATION
	 	 	36	 







 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




-iv- 









 




Table of Contents
(CONTINUED)





	 	 	 	 	 
	 	 	Page
	14.1 Product Warranties and Limitations
	 	 	36	 
	14.2 Certificate of Analysis
	 	 	36	 
	14.3 Product Inspections
	 	 	36	 
	14.4 Product Storage
	 	 	37	 
	14.5 GTX Responsibilities in GTX Territory
	 	 	37	 
	14.6 Reciprocal Indemnification Provisions
	 	 	38	 
	14.7 Conditions for Indemnification
	 	 	38	 
	14.8 Liability Insurance
	 	 	38	 
	15. STANDBY MANUFACTURING RIGHTS
	 	 	39	 
	15.1 Inability to Manufacture or Supply
	 	 	39	 
	16. MANUFACTURING INSPECTIONS AND CHANGES
	 	 	39	 
	16.1 Regulatory Inspections
	 	 	39	 
	16.2 Orion-initiated Manufacturing Changes
	 	 	40	 
	16.3 GTX-Initiated Manufacturing Changes
	 	 	40	 
	16.4 New Dosage Strengths and Formulations
	 	 	41	 
	17. PRODUCT RECALLS
	 	 	42	 
	17.1 Recall Notification
	 	 	42	 
	17.2 Recall Implementation in GTX Territory
	 	 	42	 
	17.3 Recall Costs and Expenses in GTX Territory
	 	 	42	 
	18. ADVERSE DRUG EXPERIENCES
	 	 	42	 
	18.1 Adverse Events
	 	 	42	 
	19. REPRESENTATIONS AND WARRANTIES
	 	 	43	 
	19.1 Representations and Warranties of the Parties
	 	 	43	 
	20. TERM AND EARLY TERMINATION RIGHTS
	 	 	44	 
	20.1 Term
	 	 	44	 
	20.2 Termination for Cause
	 	 	44	 
	20.3 Termination by Mutual Agreement
	 	 	45	 
	20.4 Other Termination by Orion
	 	 	45	 
	20.5 Other Termination by GTX
	 	 	45	 







 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.




-v- 









 




Table of Contents
(CONTINUED)





	 	 	 	 	 
	 	 	Page
	20.6 Effect of Termination
	 	 	46	 
	21. NOTICES
	 	 	46	 
	21.1 Manner of Giving Notices
	 	 	46	 
	21.2 Addresses for Notices
	 	 	46	 
	22. INTEGRATION
	 	 	47	 
	23. ASSIGNMENT
	 	 	47	 
	24. GOVERNING LAW AND DISPUTE RESOLUTION
	 	 	48	 
	24.1 Governing Law
	 	 	48	 
	24.2 Dispute Resolution
	 	 	48	 
	24.3 Effect of Commencing Dispute Resolution
	 	 	48	 
	25. LIMITATION OF DAMAGES
	 	 	49	 
	26. FORCE MAJEURE
	 	 	49	 
	27. RELATIONSHIP OF PARTIES
	 	 	49	 
	28. SEVERABILITY
	 	 	49	 
	29. NON-WAIVER
	 	 	50	 
	30. HEADINGS
	 	 	50	 
	31. GOVERNING LANGUAGE
	 	 	50	 
	32. EXECUTION
	 	 	50	 







 




			
	[ * ] = 	 	  Certain confidential information contained in this document, marked by brackets, has been omitted and
filed separately with the Securities and Exchange Commission pursuantis pursuant to Rule 406 of the Securities
Act of 1933, as amended.





-vi-