Ex-10.36 Partial Assignment of License & Supply Ag



 




[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS,
HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.




Exhibit 10.36




Partial Assignment of the Amended and Restated License and
 Supply Agreement




     This Partial Assignment Agreement (the “Partial Assignment”) is made and entered into
this 7th day of September, 2006 (the “Assignment Effective Date”), amongst GTx, Inc., a
corporation existing under the laws of the State of Delaware and having its principal offices at 3
North Dunlap Avenue, Van Vleet Building, Memphis, Tennessee 38163, USA (“GTx”), Orion
Corporation, a corporation existing under the laws of Finland and having its principal office
at Orionintie 1, 02200 Espoo, Finland (“Orion”), and Ipsen Limited, a company organized
under the laws of England and having its principal offices at 190 Bath Road, Slough SL1 3XE, United
Kingdom, (“Ipsen”). GTx, Orion, and Ipsen may hereinafter be referred to individually as a “Party,”
or collectively as the “Parties.”



     Whereas, GTx and Orion have entered into the Amended and Restated License and Supply
Agreement dated the 1st day of January, 2005, which has been further amended on May 26,
2006 and June 30, 2006 (collectively, hereinafter referred to as the “Orion Agreement”) pertaining
to the license and supply of Toremifene based products;



     WHEREAS, GTx and Ipsen have entered into a Collaboration and Licensing Agreement, dated as of
September 7, 2006 (the “Sublicense Agreement”), whereby GTx has sublicensed to Ipsen rights to
develop and commercialize Toremifene based products in the European Territory (as hereinafter
defined);



     Whereas, GTx desires to assign to its European partner, Ipsen, certain supply rights
and obligations under the Orion Agreement solely as necessary to allow Orion to supply Ipsen with
Toremifene based products for sale in the European Territory;



     Whereas, Orion wishes to consent to this partial assignment and to release GTx from
any obligations with respect to the rights assigned to, and obligations assumed by, Ipsen
hereunder; and



     Whereas, the Parties wish that all other terms and conditions of the Agreement shall
remain unchanged and shall be retained in full force and effect unless specifically agreed
otherwise herein.



     Now, therefore, in consideration of the promises and the mutual covenants contained
herein, and for good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties hereto agree as follows:



 





[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.



1.









 





     1. Definitions. Capitalized terms used herein and not otherwise defined
shall have the meanings given them in the Orion Agreement.



          (a) As used herein, the term “European Territory” shall mean the European Union (as defined in
Section 1.9 of the Orion Agreement), Switzerland, Norway, Iceland and Lichtenstein and the
Commonwealth of Independent States (which for purposes hereof means Russia, Belarus, Ukraine,
Moldova, Kazakhstan, Azerbaijan, Armenia, Kyrgyzstan, Uzbekistan, Tajikistan and Georgia).




          (b) As used herein, the term “GTx Territory” shall mean the United States and all other parts
of the world, except the European Territory.




     2. CONDITIONAL EFFECTIVENESS OF PARTIAL ASSIGNMENT. The effectiveness of this Partial
Assignment shall be conditioned on Ipsen and GTx fully executing the Sublicense Agreement.



     3. Partial Assignment of Supply Rights and Obligations.



          (a) Applicable Territory: This Partial Assignment is being executed by the Parties for the
purpose of GTx assigning to Ipsen certain rights and obligations under the Orion License for the
ordering, supply and payment of Orion Products within the European Territory, as such rights and
obligations are amended in accordance with Appendix 1. The specific rights and obligations assigned
to Ipsen, as hereby amended, pertain only to the European Territory and, unless expressly set forth
to the contrary in this Assignment or Appendix 1 hereto, any provisions of the Orion Agreement
which are assigned to Ipsen by GTx shall continue to apply to GTx to define its rights and
obligations within the GTx Territory without regard to the amendments to such provisions set forth
in Appendix 1. If Ipsen shall not file its Election for the PIN Indication or if the Sublicense
Agreement is terminated pursuant to Sections 12.2(c)(ii), 12.3 and 12.4 of the Sublicense
Agreement, then the Parties agree that the amendments to the Orion License set forth in Appendix 1
shall continue to apply to the Orion Products to be developed and commercialized by GTx within the
European Territory.




          (b) With respect to the European Territory and with effect from the Effective Date, GTx
assigns, transfers, conveys and delivers to Ipsen that portion of GTx’s rights and obligations to
those sections of the Orion Agreement listed in Appendix 1 of this Partial Assignment, as amended
in accordance with the amendments specified in Appendix 1(the “Assigned Ipsen Supply Terms”), so
that a new agreement is entered into between Ipsen and Orion under which Ipsen and Orion will
perform the obligations contained in the Assigned Ipsen Supply Terms and be entitled to the rights
contained in such Assigned Ipsen Supply Rights (the “Assigned Supply Agreement”).




          (c) Orion hereby consents to the assignment by GTx to Ipsen of the Assigned Ipsen Supply
Terms. Orion will, with effect from the Effective Date, observe and perform in favour of Ipsen all
liabilities and obligations set out in the Assigned Supply Agreement to the same extent as if Ipsen
had been an original party to the Orion Agreement in relation to the Assigned Ipsen Supply Terms,
each as arise or fall to be performed on and following the Effective Date.



 




[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN
THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.



2.









 





          (d) GTx shall remain jointly and severally liable with Ipsen towards Orion as regards the
payment due by Ipsen in accordance with Section 14.4.2 of the Orion Agreement, as assigned to Ipsen
pursuant to Appendix 1 of this Partial Assignment. Ipsen agrees to hold harmless and indemnify GTx
for any such payment owing to Orion and agrees to pay within thirty (30) days of GTx’s written
notice thereof any amounts which GTx shall have to pay to Orion for Ipsen on account of GTx’s joint
and several liability hereunder, with interest thereon at the rate of interest set forth in Section
3.8 of the Sublicense Agreement.




          (e) Any terms and conditions relating to the Fareston Product under Articles 14, 15, 17, 18
and 19 of the Orion Agreement (including any cross-referenced provisions that may be logically
applicable by reference or incorporation in such Articles) shall not be assigned or otherwise
applicable to Ipsen. For clarity, GTx shall continue to be bound to any such provisions relating
to Fareston Product, to the extent such provisions remain in effect and such obligations have not
already been fully performed by GTx.




     4. PRODUCT DEVELOPMENT AND REGISTRATION. Orion agrees to extend to Ipsen as a GTX Unaffiliated
Sublicensee those rights it extends to GTx under Section 7 of the Orion Agreement to assist Ipsen
in its Development and regulatory activities within the European Territory, but only to the extent
set forth in such Section 7 and further only to the extent such assistance has not previously
provided to GTx under the Orion Agreement. The Parties acknowledge that unless Ipsen shall file its
Election for the PIN Indication (as such terms are defined in the Sublicense Agreement) within the
time period set forth in the Sublicense Agreement, GTx may again assume all rights and obligations
in and to the 20 mg Toremifene tablet for the PIN Indication, and this Partial Assignment shall
become null and void as to Ipsen with regards to the supply of the 20mg Toremifene tablet.



     5. Ipsen’s Obligations Under the Assigned Ipsen Supply Terms. With effect
as from the Effective Date, Ipsen agrees to assume, perform and be obligated with respect to all of
the rights and obligations under the Assigned Ipsen Supply Terms within the European Territory.



     6. Confidentiality. Confidentiality and non-use obligations between Orion
and GTx are specified in the Orion Agreement, between Gtx and Ipsen in the Sublicense Agreement and
between Orion and Ipsen in Appendix 1 of this Assigned Supply Agreement. Orion, GTx and Ipsen
understand and agree that relating to this Partial Assignment the Parties may need to exchange
information which is confidential and/or proprietary to a Party, including without limitation the
terms and conditions of the Partial Assignment. Such confidential information so disclosed shall be
disclosed under and subject to the terms and conditions of the aforementioned agreements and shall
be kept secret and confidential as defined in those agreements.



     7. Reservation of Rights in the GTx Territory. Notwithstanding anything to
the contrary set forth herein, GTx reserves all rights under the Orion Agreement with respect to
ordering, supply, and payment of Orion Product for sale by or on behalf of GTx of Product in the
Field (but excluding the Orion Field) in the GTx Territory.




 



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3.









 





     8. Consent and Partial Assignment; Release of GTx. Subject to Article 3(d)
of this Partial Assignment, Orion hereby consents to the foregoing Partial Assignment and releases
GTx from any obligations under the Orion Agreement in respect of the Assigned Ipsen Supply Terms as
from the Effective Date.



     9. Effect on Orion Agreement. Except as expressly modified hereby, the
Orion Agreement shall remain in full force and effect between GTx and Orion, and nothing in this
Partial Assignment is intended to impair or alter any other rights, obligations, or remedies of GTx
and/or Orion, respectively, under the Orion Agreement. Any future amendments or waivers under the
Orion Agreement that pertain to the Assigned Ipsen Supply Terms shall require the written
agreement of Ipsen, and Orion provided that no amendment or waiver shall adversely affect any
rights of GTx under the Orion Agreement without having first obtained GTx’s prior written consent.
Ipsen agrees to provide GTx with prompt written notice of any amendment or waiver of the Orion
Agreement entered into between Ipsen and Orion which do not otherwise require GTx’s prior written
consent, as set forth in the preceding sentence. Orion and GTx agree that Ipsen shall have no
liability or responsibility for any acts, omissions or failures of performance by Orion and GTx
under the Orion Agreement.



     10. Term of the Assigned Supply Agreement. 



          (a) Term of the Assigned Supply Agreement. The Assigned Supply Agreement shall enter into
force on the Effective Date and shall expire on a country by country basis until the later of (a)
the date of expiration or invalidation of the last to expire or to be invalidated of the GTx Patent
Rights (as defined in the Orion Agreement) or (b) the expiration or termination of the last to
expire of the marketing or regulatory exclusivity granted by the European Medicines Agency or other
equivalent regulatory authority for the Product (as defined in the Orion Agreement) or (c) earlier
terminated in accordance with this Section. The Assigned Supply Agreement may be terminated as
follows:




               (i) Under the terms and conditions set forth in Section 14.9 of the Orion License, as amended
and assigned to Ipsen pursuant to Appendix 1 of this Agreement;



               (ii) Under the terms and conditions set forth in Section 16.1 of the Orion Agreement, as
amended and assigned to Ipsen pursuant to Appendix 1 of this Agreement;



               (iii) Under the terms and conditions set for in Sections 21.2.1, 21.2.2 and 21.3 of the Orion
Agreement, as amended and assigned to Ipsen pursuant to Appendix 1 of this Agreement;



               (iv) In case of material breach of the Partial Assignment;



               (v) In case of termination of the Orion Agreement, the Sublicense Agreement and/or the Partial
Assignment, except in the event GTx shall again acquire rights to the Orion Products, as stated in
the last sentence of Section 3(a) hereof, the Assigned Supply Agreement will continue to apply to
the Orion Products to be developed and commercialized by GTx within the European Territory.




 



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4.









 





          (b) Effect of Termination of the Assigned Supply Agreement. This Partial Assignment is
automatically terminated and all Assigned Ipsen Supply Terms as amended and assigned pursuant to
Appendix1 shall automatically revert back to GTx and the terms and conditions as set forth in
Section 21.5 of the Orion Agreement as amended and assigned to Ipsen pursuant to Appendix 1 shall
apply.




          (c) Amendments to the Assigned Supply Agreement. Any amendment to the Assigned Supply
Agreement shall be agreed in writing between Ipsen and Orion. Subject to Section 9 of this
Assignment, such amendment shall be communicated for information purposes to GTx by Ipsen.




     11. OTHER AGREEMENTS



     Orion and Ipsen (and GTx, for purposes of (b) and (c) hereof) hereby agree to use their
commercially reasonable endeavors to negotiate in good faith and under commercially reasonable
terms:



          (a) [ * ];




          (b) a quality agreement (the “Quality Agreement”), as provided for in Section 15.2 of the
Orion Agreement, as amended and assigned to Ipsen pursuant to Appendix 1 to this Agreement;




          (c) a safety data exchange agreement, as provided for in Section 19 of the Orion Agreement, as
amended and assigned to Ipsen pursuant to Appendix 1 to this Agreement.




     12. GENERAL



          (a) Assignment. Neither Party may assign this Partial Assignment 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 (i) to an Affiliate in accordance with the terms
of this Partial Assignment, in which case notification thereof shall be provided to the other Party
prior to such assignment to an Affiliate, or (ii) in connection with a merger, consolidation or
similar reorganization. For clarity, this Partial Assignment shall survive any such merger,
consolidation or reorganization of either Party with or into, another party and no consent for such
merger, consolidation or reorganization shall be needed. Neither Party shall unreasonably withhold
its consent (which shall be provided promptly after a request is made) to any 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 Partial Assignment to an
Affiliate of the assigning Party shall not relieve the assigning Party of its responsibilities and
obligations hereunder.




          (b) Severability. In case one or more of the provisions contained in this Partial Assignment
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 Partial Assignment,
but this Partial Assignment shall be construed by limiting such invalid, illegal or




 



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5.









 




unenforceable provision, if such is not possible, by deleting such provision from this Partial
Assignment.




          (c) Governing law and Dispute Resolution. The Partial Assignment, 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.




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 Partial Assignment 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.




          (d) Execution. This Partial Assignment shall be executed by the Parties in three (3) 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 Partial Assignment to be exchanged by the Parties promptly thereafter.




(SIGNATURE PAGE FOLLOWS)



 



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6.









 





     In Witness Whereof, GTx, Ipsen and Orion have caused this Partial Assignment to be
executed and effective as of the Assignment Effective Date.



	 	 	 	 	 	 	 	 	 	 	 
	GTx, Inc.	 	 	 	Ipsen Limited	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Mitchell Steiner
	 	 	 	By:
	 	/s/ Alistair Stokes	 	 
	 

	 	 

Mitchell Steiner, M.D.
	 	 	 	 	 	 

	 	 
	Title:

	 	Vice-Chairman and CEO
GTx, Inc.
	 	 	 	Name:
	 	Alistair Stokes	 	 
	 
	 	 	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Title:
	 	Director and Chief Executive Officer	 	 
	By:

	 	/s/ Marc Hanover	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	 	 	 	 	 
	 

	 	Marc Hanover	 	 	 	 	 	 	 	 
	Title:

	 	President and COO
GTx, Inc.	 	 	 	 	 	 	 	 






	 	 	 	 	 
	Orion Corporation	 	 
	ORION PHARMA	 	 
	By:

	 	/s/ Timo Lappalainen	 	 
	Name:

	 	 

Timo Lappalainen
	 	 
	 

	 	 	 	 
	Title:

	 	Senior Vice President	 	 
	 

	 	 	 	 
	 
	 	 	 	 
	By:

	 	/s/ Hannu Wennonen	 	 
	 

	 	 	 	 
	Name:

	 	Hannu Wennonen	 	 
	 

	 	 	 	 
	Title:

	 	Director	 	 
	 

	 	 	 	 






 



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7.









 









ASSIGNED TERMS AND RELATED AMENDMENTS



Any reference to a Section shall be construed as a reference to a Section of the Orion Agreement as
amended and assigned to Ipsen pursuant to this Appendix 1. If there is a reference herein to any
Section of the Orion Agreement which is not otherwise hereby amended, then in those such Sections
any reference to GTx shall be construed to apply to Ipsen.




	 	 	 
	Section	 	Terms and amendments
	Definitions

	 	[ * ]
	2.1.2 Manufacturing Rights Reserved

	 	[ * ]
	7.1.2 (b) Orion Activities

	 	[ * ]
	8.1 Confidentiality Obligation

	 	[ * ]
	8.2 Permitted Disclosure

	 	[ * ]
	8.3 Confidential information

	 	[ * ]
	8.4 Duration of Confidentiality Obligation

	 	[ * ]
	8.5 Publicity and Announcements

	 	[ * ]
	14.1.1 Product Supply

	 	[ * ]






 




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8.









 








	 	 	 
	Section	 	Terms and amendments
	14.1.2 Product Delivery

	 	[ * ]
	14.1.3 Product Shipping Instructions

	 	[ * ]
	14.2 Orion Affiliates and Subcontractors

	 	[ * ]
	14.3.1 Rolling Forecasts

	 	[ * ]
	14.3.2 Excess quantities

	 	[ * ]
	14.3.3 Minimum Quantities

	 	[ * ]
	14.4.1 Commercial Pricing Formula

	 	[ * ]
	14.4.2 Invoicing and Payment

	 	[ * ]
	14.4.3 Price Changes

	 	[ * ]
	14.5 Resale Prices

	 	[ * ]
	14.6.1 Product Supply for Testing and Registration

	 	[ * ]
	14.6.2 Supply of Toremifene

	 	[ * ]
	14.7 Agreement Terms Govern

	 	[ * ]
	14.9 Termination of Product Supply

	 	[ * ]
	15.1
Product Warranties and Limitations

	 	[ * ]





 




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9.









 








	 	 	 
	Section	 	Terms and amendments
	15.2 Certificate of Analysis

	 	[ * ]
	15.3.1 Ipsen Inspection and Analysis

	 	[ * ]
	15.3.2 Orion Response

	 	[ * ]
	15.4 Product storage

	 	[ * ]
	15.5.1 Labeling

	 	[ * ]
	15.6.1 Orion Indemnification

	 	[ * ]
	15.6.2 Ipsen Indemnification

	 	[ * ]
	15.7 Conditions for Indemnification

	 	[ * ]
	15.8 Liability Insurance

	 	[ * ]
	 

	 	[ * ]
	 

	 	[ * ]
	16.1 Inability to Manufacture or supply

	 	[ * ]
	16.2 Back-up manufacturing right

	 	[ * ]





 




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10.









 








	 	 	 
	Section	 	Terms and amendments
	16.3 Maintenance of inventory

	 	[ * ]
	17.1 Regulatory inspections

	 	[ * ]
	17.2 Orion-initiated manufacturing changes

	 	[ * ]
	17.3.1 Ipsen request for manufacturing changes

	 	[ * ]
	17.3.2 Required manufacturing changes

	 	[ * ]
	17.3.3 Other manufacturing changes

	 	[ * ]
	17.4 New dosage strengths and formulation

	 	[ * ]
	18. Recall

	 	[ * ]
	18.3 Recall costs and expenses in EuropeanTerritory

	 	[ * ]
	19. Adverse Drug Experiences

	 	[ * ]

[ * ]
	21.1 Term

	 	[ * ]
	21.1 Termination

	 	[ * ]






 



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11.









 








	 	 	 
	Section	 	Terms and amendments
	for Cause and 21.2.1 Bankruptcy
	 	 
	21.2.2 Material Breach

	 	[ * ]
	21.3 Termination by Mutual Agreement

	 	[ * ]
	21.5 Effect of termination

	 	[ * ]
	22.1 Manner of giving notices

	 	[ * ]
	22.2 Addresses for Notices

	 	[ * ]
	23. Integration

	 	[ * ]
	24. Assignment

	 	[ * ]
	25.1 Governing law

	 	[ * ]
	25.2 Dispute resolution

	 	[ * ]
	25.3 Effect of commencing dispute resolution

	 	[ * ]
	26. Limitation of damages

	 	[ * ]
	27. Force majeure

	 	[ * ]
	28. Relationships of Parties

	 	[ * ]
	29. Severability

	 	[ * ]





 



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12.









 








	 	 	 
	Section	 	Terms and amendments
	30. Non-waiver

	 	[ * ]
	31. Headings

	 	[ * ]
	32. Governing language

	 	[ * ]
	33. Execution

	 	[ * ]
	Schedule C

	 	[ * ]
	Amendment of May 23, 2006

	 	[ * ]
	Amendment of June 30, 2006

	 	[ * ]






 



[ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.





13.