Document:

Exhibit 10.2

 

First Amendment
 To the
 License, Supply, Marketing, Distribution And Collaboration Agreement

 

This First Amendment effective as of May 20, 2004 (the “First Amendment”), amends the License, Supply, Marketing, Distribution And Collaboration Agreement by and between Upsher-Smith Laboratories (“USL”) and Orion Corporation (“Orion”) effective as of November 24, 2003 (the “Agreement”).

 

Section 8.8 of the Agreement (entitled “Pharmacovigilance”) provides that “as soon as reasonably possible, the drug safety departments of both Parties shall meet and determine the approach to be taken for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product, which approach shall be documented in a Schedule 5 to this Agreement to be finalized and attached to, and incorporated in, this Agreement not later than one hundred eighty days (180) days after the Date of Agreement.” (All capitalized terms not defined in this First Amendment shall have the meaning given in the Agreement.) That one hundred eighty (180) day period will expire on May 22, 2004. The Parties are continuing to work in good faith on completing Schedule 5, but require additional time to do so. The parties now anticipate that Schedule 5 will be finalized and ready for execution on or before July 1, 2004, and wish to amend the Agreement to provide such additional time for the finalization and execution of Schedule 5.

 

Now therefore, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Orion and USL agree to amend the Agreement as follows:

 

1.                                      Section 8.8 is amended to delete the words in Section 8.8 “not later than one hundred eighty days (180) days after the Date of Agreement” and to insert in their place the words “not later than July 1, 2004.”

 

2.                                      Except as expressly provided in this First Amendment, the Agreement shall remain unchanged and in full force and effect.

 

[Continued on Next Page]

 

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IN WITNESS WHEREOF, the Parties’ duly authorized representatives hereto have executed this Amendment as of the day and year first above written.

 

SIGNATURES

 

	
Signed
    	
 
    	
 
    	
 
    	
Signed
    
	
ORION   CORPORATION
    	
 
    	
 
    	
 
    	
UPSHER-SMITH   LABORATORIES, INC.
    
	
By
    	
 
    	
 
    	
 
    	
By
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
/s/ Timo   Lappalainen 
    	
 
    	
/s/ Hannu   Wennonen
    	
 
    	
/s/   Thomas W. Burke
    
	
Signature   
    	
 
    	
Signature
    	
 
    	
Signature
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Timo   Lappalainen 
    	
 
    	
Hannu   Wennonen
    	
 
    	
Thomas W.   Burke
    
	
Name 
    	
 
    	
Name
    	
 
    	
Name
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Senior   Vice President
    	
 
    	
 Director
    	
 
    	
Vice   President, Corporate Development
    
	
Title 
    	
 
    	
Title
    	
 
    	
Title
    
	
(Authorized   Officer) 
    	
 
    	
(Authorized   Officer)
    	
 
    	
(Authorized   Officer)
    

 

2Exhibit 10.3

 

Second Amendment
 To the
 License, Supply., Marketing, Distribution And Collaboration Agreement

 

This Second Amendment effective as of June 30, 2004 (the “Second Amendment”), amends the License, Supply, Marketing, Distribution And Collaboration Agreement by and between Upsher-Smith Laboratories (“USL”) and Orion Corporation (“Orion”) effective as of November 24, 2003, as amended by the First Amendment (the “First Amendment”) dated effective May 20, 2004 (the License, Supply, Marketing, Distribution and Collaboration Agreement, as amended, being referred to as the “Agreement”).

 

Section 8.8 of the Agreement (entitled “Pharmacovigilance”), as amended, provides that “as soon as reasonably possible, the drug safety departments of both Parties shall meet and determine the approach to be taken for the collection, review, assessment, tracking and filing of information related to adverse events associated with the Product, which approach shall be documented in a Schedule 5 to this Agreement to be finalized and attached to, and incorporated in, this Agreement not later than July 1, 2004.” (All capitalized terms not defined in this Second Amendment shall have the meaning given in the Agreement.) The Parties are continuing to work in good faith on completing Schedule 5, but require additional time to do so. The parties now anticipate that Schedule 5 will be finalized and ready for execution on or before August 31, 2004, and wish to amend the Agreement to provide such additional time for the finalization and execution of Schedule 5.

 

Now therefore, for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, Orion and USL agree to amend the Agreement as follows:

 

1.                                      Section 8.8 is amended to delete the words in Section 8.8 “not later than July 1, 2004” and to insert in their place the words “not later than August 31, 2004.”

 

2.                                      Except as expressly provided i n t his Second Amendment, the Agreement s hall remain unchanged and in full force and effect.

 

[Continued on Next Page]

 

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IN WITNESS ‘WHEREOF, the Parties’ duly authorized representatives hereto have executed this Amendment as of the day and year first above written.

 

SIGNATURES

 

	
Signed
    	
 
    	
 
    	
 
    	
Signed
    
	
ORION   CORPORATION
    	
 
    	
 
    	
 
    	
UPSHER-SMITH   LABORATORIES, INC.
    
	
By
    	
 
    	
 
    	
 
    	
By
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
/s/ Timo   Lappalainen 
    	
 
    	
/s/ Hannu   Wennonen
    	
 
    	
/s/ Mark   S. Robbins
    
	
Signature   
    	
 
    	
Signature
    	
 
    	
Signature
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Timo   Lappalainen 
    	
 
    	
Hannu   Wennonen
    	
 
    	
Mark. S.   Robbins
    
	
Name 
    	
 
    	
Name
    	
 
    	
Name
    
	
 
    	
 
    	
 
    	
 
    	
 
    
	
Senior   Vice President 
    	
 
    	
Director
    	
 
    	
Vice   President
    
	
Title 
    	
 
    	
Title
    	
 
    	
Title
    
	
(Authorized   Officer) 
    	
 
    	
(Authorized   Officer)
    	
 
    	
(Authorized   Officer)
    

 

2Exhibit 10.4

 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

 

Third Amendment
 to the
 License, Supply, Marketing, Distribution and Collaboration Agreement

 

This Third Amendment effective as of May 20, 2010 (the “Third Amendment”), amends the License, Supply, Marketing, Distribution and Collaboration Agreement by and between Upsher-Smith Laboratories, Inc. (“USL”) and Orion. Corporation (“Orion”) effective as of November 24, 2003, as amended by the First Amendment (the “First Amendment”) dated effective May 20, 2004, and the Second Amendment (the “Second Amendment”) dated effective June 30, 2004 (the License, Supply, Marketing, Distribution and Collaboration Agreement, as amended, being referred to as the “Agreement”). Capitalized terms appearing in this Third Amendment not defined herein have the meaning given to them in the Agreement.

 

BACKGROUND. USL and Orion desire to amend the existing Agreement so as to reflect their agreements as follows: (1) that Orion (and/or Orion’s licensees) may reference and use USL Data that may benefit the marketing, promotion or regulatory approvals/filings for the estradiol gel products (marketed, inter alia, under the trademark Divigeign, herein after referred to as “Divigel products”) in markets outside the Territory and Japan, (2) to clarify and amend the Know-How Royalty rate applicable to sales of Product in Canada by Ferring, Inc. (“Ferring”), and (3) to eliminate the Minimum Net Sales requirements currently provided for in the Agreement.

 

The parties have agreed that Orion and/or Orion’s licensees shall have the right to reference and use USL Data for marketing, promotion or regulatory approvals/filings for the Divigel products in markets outside the Territory and Japan, and USL has agreed to provide Orion and/or Orion’s licensees with such right to reference and use USL Data to potentially enhance the Divigel products’ sales in such markets. The Parties agree that the consideration to USL for providing to Orion the right to reference and use USL Data as set forth herein, shall be Orion’s acceptance of the terms provided in this Third Amendment.

 

In consideration of the foregoing “Background” which is incorporated herein and the mutual covenants hereinafter expressed, and for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the parties agree to amend the Agreement as follows:

 

1.                                      Section 6.9 of the Agreement, relating to Know-How Royalty, shall be amended to reflect the Know-How Royalty rate USL will pay Orion on Net Sales of Product in Canada by Farling. Section 6.9 shall be amended by adding a new paragraph immediately after the existing Section 6.9 as follows:

 

“Notwithstanding Section 6.10.6 and the foregoing paragraph, with respect to Product sold in Canada by Ferring, commencing upon the date Health Canada approves the labeling for the Product in Canada, and continuing for a period of eighteen (18) months loll wing such approval, USL agrees to pay Orion a Know-How Royalty equal to [***] of Product Net Sales in Canada. Following the expiration of this eighteen (18) month period, Know-How Royalty shall revert to the Applicable Percentage then in effect under the terms of the Agreement.”

 

2.                                      Section 5.6 of the Agreement, relating to the sharing of USL Sublicensee Fees, shall be deleted in its entirety, with the understanding that USL shall seek in good faith ways to channel [***] of the Sublicensee Fees payable by Ferring to the marketing and promotion of the Product in the Territory.

 

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3.                                      Section 7.2 of the Agreement, relating to Projected Sales Level Statements and Minimum Net Sales Obligation, shall be amended by striking the language starting at the beginning of the second paragraph and continuing to the end of Section 7.2, and all references to Minimum Net Sales in the Agreement shall likewise be deleted. The Agreement shall in all other respects be modified and amended to reflect the fact that USL has no Minimum Net Sales obligation under the terms of the Agreement.

 

4.                                      Section 7.3 of the Agreement, relating to Failure to Achieve Minimum Net Sales, Section 7.4 of the Agreement, relating to Certain USL Rights, Section 7.5 of the Agreement, relating to Certain Orion Rights, and Section 20.3, relating to Termination Due to Shortfall, shall each be deleted, and all references to these sections in the Agreement shall likewise be deleted.

 

5.                                      In consideration of Paragraphs 1 through 4 above, USL grants to Orion, Orion’s successors in interest permitted under Section 24.2 and/or Orion’s licensees the irrevocable right to reference and use USL Data, as it sees appropriate, free-of-charge and without any limitation in time, in connection with the marketing, promotion and/or regulatory approvals/filings for additional dosage strengths in any country outside the Territory and Japan to potentially enhance the marketing of Divigel products in such countries. Orion understands and agrees that Orion will not sell the USL Data to any of its current or future licensees without the prior written approval of USL, which approval may be withheld at USL’s sole discretion. Except as provided in this Third Amendment, Section 4.6.5 of the Agreement, relating to USL Data, shall remain unchanged.

 

6.                                      Except as expressly provided in this Third Amendment, the Agreement shall remain unchanged and in full force and effect.

 

[Remainder of page is blank.]

 

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IN WITNESS WHEREOF, the Parties’ duly authorized representatives hereto have executed this Third Amendment as of the day and year first above written.

 

SIGNATURES

 

	
Signed
    	
 
    	
Signed
    
	
ORION   CORPORATION
    	
 
    	
UPSHER-SMITH   LABORATORIES, INC.
    
	
By
    	
 
    	
By
    
	
 
    	
 
    	
 
    
	
/s/ Liisa   Hurme
    	
 
    	
/s/   Thomas W. Burke
    
	
Signature
    	
 
    	
Signature
    
	
 
    	
 
    	
 
    
	
Liisa   Hurme
    	
 
    	
Thomas W.   Burke
    
	
Name
    	
 
    	
Name
    
	
 
    	
 
    	
 
    
	
Senior   Vice President
    	
 
    	
EVP of   Commercial Operations
    
	
Title
    	
 
    	
Title
    
	
(Authorized   Officer)
    	
 
    	
(Authorized   Officer)
    
	
 
    	
 
    	
 
    
	
By
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/ Jukka   Muhonen
    	
 
    	
 
    
	
Signature
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/ Jukka   Muhonen
    	
 
    	
 
    
	
Name
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Director
    	
 
    	
 
    
	
Title
    	
 
    	
 
    
	
(Authorized   Officer)
    	
 
    	
 
    

 

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