OSTEOMARK SERUM KIT LICENSE AGREEMENT









Exhibit

10.12E




 




SERUM OSTEOMARK LICENSE

AGREEMENT




 




This License Agreement (“Agreement”) is made and entered into as of February

20, 2002 (“Effective Date”), by and between Ostex International, Inc., a

Washington corporation (“Ostex”) and Mochida Pharmaceutical Co., Ltd., a

Japanese corporation (“Mochida”).




 




RECITALS




 




A.               On August 21, 1992,

Ostex and Mochida entered into a Research and Development Agreement regarding

an in vitro serum diagnostic

assay based on certain technology discovered by Dr. David Eyre (“R & D

Agreement”).




B.                 Under the R &

D Agreement, Ostex granted to Mochida the exclusive option to obtain from Ostex

the exclusive license to import, assemble, market, promote, sell and distribute

Serum Finished Product (as hereinafter defined).




C.                 Mochida exercised

the option right to obtain the exclusive license for Serum Finished Product,

pursuant to Section 6.1 of the R & D Agreement, on December 17, 1996.




D.                Section 6.1 of the

R & D Agreement provides that this Agreement shall substantially incorporate

the form of the Osteomark® License Agreement for Osteomark Urinary

Kit concluded between Ostex and Mochida dated August 21, 1992, as amended by

the First Amendment dated August 21, 1992, the Second Amendment dated December

24, 1997 and the Third Amendment dated January 1, 2000 (collectively “Urinary

Agreement”).




 




AGREEMENTS




 




In consideration for the mutual covenants contained herein and for

other good and valuable consideration, the receipt and sufficiency of which are

hereby acknowledged, the parties hereby agree as follows:




 




1.                 Definition of

the terms




All capitalized terms that are used in this

Agreement and are not otherwise defined herein are intended to have the

meanings assigned to such terms in the Urinary Agreement.




 





























 




2.                 License




Ostex hereby grants to Mochida, and Mochida hereby

accepts, an exclusive, royalty-free, nontransferable license to the Technology,

Patent Rights, Know-How and Confidential Information possessed or to be

possessed by Ostex, to enable Mochida (a) to use certain Know-How to assure

quality control, to test the Serum Finished Product and to perform Serum

Osteomark assay, and (b) to import, market, promote, sell, and distribute the

Serum Finished Product in the Territory, in accordance with and subject to the

terms and conditions of this Agreement.




 




The

term “Serum Osteomark” means that certain Ostex Product existing as of the

Effective Date in the form of an in vitro serum

Diagnostic assay for amino-terminal telopeptides of type I collagen (“NTx”),

and the term “Serum Finished Product” means the assembled Diagnostic Kit

containing Serum Osteomark in the form of a microtiter plate, which kit may

incorporate any and all immunoassay formats now existing or hereafter created,

including without limitation, enzyme immunoassays, radio immunoassays,

fluorescent immunoassays, luminescent immunoassays, and colored particle

immunoassays, and which kit shall be marketed, promoted, sold and distributed

by Mochida pursuant to this Agreement.




 




3.                 Payment Terms




Both

parties agreed to the following Section 3.1 and Section 3.2 based on Section

6.2 and 6.3 of the R & D Agreement:




 




3.1           Up-Front License Fee

for Serum Finished Product




In

consideration of any and all rights and licenses for Serum Finished Product

granted to Mochida under this Agreement, Mochida shall pay Ostex a

nonrefundable license fee of Five Hundred Thousand Dollars (U.S.$500,000),

which fee shall not be subject to offset for any reason.  Mochida shall pay Ostex such up-front

license fee in accordance with the following schedule:




(a)          Within thirty (30) days

after the Effective Date of this Agreement, Mochida shall pay Ostex Two Hundred

Fifty Thousand Dollars (U.S.$250,000);




(b)         Within thirty (30) days

after Mochida files with the Ministry of Health, Labor and Welfare (“MHLW”,

formerly “Koseisho” or “MHW”) an

application for the approval for the Serum Finished Product, Mochida shall pay

Ostex Two Hundred Fifty Thousand Dollars (U.S.$250,000).




 




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3.2           Additional License

Fee Upon MHLW Approval




Within

thirty (30) days of receipt of the official announcement of the reimbursement

price from the MHLW regarding Serum Finished Product for its intended use in

connection with medical procedures, Mochida shall pay Ostex a one-time, nonrefundable

license fee of Two Hundred Fifty Thousand Dollars (US$250,000).




 




4.               Initial License

Term




This

Agreement shall be in full force and effect commencing on the Effective Date

and shall remain in full force and effect for fifteen (15) years thereafter or

until the abandonment, expiration or invalidation of the last remaining Patent

Right in the Territory, whichever is earlier, unless this Agreement is

otherwise terminated earlier by operation of law or pursuant to the terms and

conditions contained herein.




 




5.               Other terms and

conditions




(i)                         All terms

and conditions of the Urinary Agreement (including, without limitation,

Sections 2.2, 5 and 10.2 thereof, and specifically excluding Sections 2.1, 4.1,

4.2, 4.6 and 10.1 thereof), and




(ii)                      other terms

and conditions agreed separately between both parties in accordance with and/or

relating to the Urinary Agreement,




shall apply mutatis mutandis to this Agreement  by replacing (a) the term “OsteomarkTM (urinary assay)” with “Serum

Osteomark” and (b) “Second Generation Urinary Assay” and “Finished Product”

with “Serum Finished Product,” and by adapting definitions and meanings of

other terms of the Urinary Agreement to the replacements (a) and/or (b) above.




 




For the avoidance of doubt, if any provisions

of the Urinary Agreement are amended after the Effective Date, such amended

provisions shall automatically apply to this Agreement unless otherwise

specifically designated.




 




In the event that a provision of the Urinary

Agreement is found inapplicable or unsuitable for the Serum Finished Product

after conclusion of this Agreement, both parties shall discuss in good faith

and interpret such provision to the extent necessary to conform to the actual commercial

terms agreed between the parties and taking into account the intent of the

parties.




 




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DATED as of the Effective Date.




 




	

  Ostex

  International, Inc.


  	

  Mochida

  Pharmaceutical Co., Ltd.


  
	

   


  	

   


  	

   


  
	

  /s/ Thomas A. Bologna


  	

   


  	

  /s/ Naoyuki Mochida


  
	

  Name:


  	

  Thomas A.

  Bologna


  	

  Name:


  	

  Naoyuki

  Mochida


  
	

  Title:


  	

  Chairman,

  President and 


  	

  Title:


  	

  President


  
	

   


  	

  Chief Executive Officer


  	

   


  	

   


  
	

  Place and

  date:


  	

  Seattle, WA

  February 20, 2002


  	

  Place and

  date:


  	

  Tokyo, March

  1, 2002


  
					





 




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