EX-10.2 Amendment dated May 3, 2007, to Letter Agr



 





Exhibit 10.2





The confidential portions of this exhibit have been filed separately with the
Securities and Exchange Commission pursuant to a confidential treatment request in
accordance with Rule 24b-2 of the Securities and Exchange Act of 1934, as amended.
REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN ***.



May 3, 2007




Shire Pharmaceuticals Ireland Limited

6 Fitzwilliam Square

Dublin 2, Ireland




	 	 	 
	Re:

	 	Letter Agreement dated as of June 15, 2004 by and between Noven
	 

	 	Pharmaceuticals, Inc. (“Noven”) and Shire US Inc. (“Shire US”) relating
	 

	 	to the Development of the Amphetamine Transdermal Delivery System
	 

	 	(the “Agreement”)






Ladies and Gentlemen:




     This letter agreement (the “Amendment”) supplements and amends the Agreement between Noven and
Shire US relating to the development of an amphetamine transdermal delivery system (the “Product”),
such Agreement having been assigned by Shire US to and assumed by its affiliate Shire
Pharmaceuticals Ireland Limited (“Shire Ireland” and, together with Shire US, “Shire”) pursuant to
its terms and that certain Assignment and Assumption Agreement between Shire US and Shire Ireland
dated as of May 25, 2006. This Amendment supersedes and replaces the letter agreement between the
parties dated July 20, 2006.



     This Amendment and the Agreement relate to the transaction agreement dated as of February 26,
2003 by and among Noven, Shire US and Shire Pharmaceuticals Group plc (the “Transaction
Agreement”), such Transaction Agreement having been assigned by Shire US to and assumed by Shire
Ireland pursuant to its terms and that certain Assignment and Assumption Agreement between Shire US
and Shire Ireland dated as of April 7, 2003.



     In consideration of the mutual covenants and agreements of the parties contained herein and
for other good and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, and intending to be legally bound, Noven and Shire Ireland hereby agree as follows:




	1.	 	Capitalized Terms. Capitalized terms used and not defined in this Amendment shall
have the meanings set forth in the Agreement.






	2.	 	Satisfaction of Certain Obligations. Noven acknowledges and agrees that Shire has
paid to Noven an aggregate sum of five hundred thousand dollars ($500,000) as consideration
for work performed by Noven pursuant to and in full and complete satisfaction of Shire’s
payment obligations under Sections 2(a) and 2(b) of the Agreement.




-1-









 












	3.	 	Amendments to the Plan. Section 2 of the Agreement * * * attached thereto are hereby
amended as follows:






	 	3.1.	 	From the date of this Amendment, Noven agrees that it is solely responsible for
the Plan, the Product and the Project, including, without limitation, and for
illustrative purposes only, * * *, Shire’s obligation * * * under Section 2(c) of the
Agreement, and Shire’s obligation * * * under Section 2(d) of the Agreement * * *.
Noven agrees that it shall proceed with the Project solely of its own accord and that
Shire is released of any and all obligations relating to the Plan, the Product and the
Project under the Agreement. Notwithstanding the foregoing, Noven shall provide to
Shire any and all documents, correspondence, and plans for or communications with FDA,
and Shire shall have the right to review, modify and approve all such documents,
correspondence and communications prior to their use or occurrence and to participate
in all meetings and other communications with FDA, provided that such rights shall
cease to apply if Shire does not exercise its Buy-Back Right in accordance with Section
3.3.
	 
	 	3.2.	 	Noven agrees that it shall be solely responsible for any and all activities
necessary * * * described in Section 2(d) of the Agreement * * *, including any and all
costs for activities that are determined to be necessary * * *.
	 
	 	3.3.	 	Shire shall have the right (the “Buy-Back Right”), in its sole discretion, to a
one-time election to resume its exclusive participation with Noven in the development
of the Product upon giving written notice of such election to Noven * * * of the later
of (a) * * * and (b) * * *. In the event that Shire exercises its Buy-Back Right,
Shire shall pay to Noven, on a date that is * * * of Noven’s receipt of Shire’s notice
of exercise of the Buy-Back Right (the “Payment Date”), the following payments:






	 	3.3.1.	 	two million five hundred thousand dollars ($2,500,000); plus
	 
	 	3.3.2.	 	three million three hundred seventy five dollars ($3,375,000), such amount
representing the aggregate sum of the milestone payments set forth in Sections
2(c)-2(e) of the Agreement.






	 	3.4.	 	In the event that Shire exercises its Buy-Back Right, Shire and Noven agree
that (a) Section 2(f) of the Agreement, including Shire’s payment obligation
thereunder, shall remain unchanged; (b) * * *; and (c) Shire shall assume
responsibility for the obligations relating to the Plan, Product and the Project from
and after the Payment Date as set forth in the Agreement.
	 
	 	3.5.	 	In the event that Shire does not exercise its Buy-Back Right as set forth in
this Amendment Section 3, Shire shall be deemed to have terminated the Agreement
without cause and with notice given pursuant to Section 7 of the Agreement and the
terms of that provision shall apply.










-2-









 











     4. Amendments relating to the Product License Agreement.




	 	4.1.	 	Section 6 of the Agreement is hereby amended and restated in its entirety as
follows:
	 
	 	 	 	“In the event that Shire exercises its Buy-Back Right, Shire and Noven will
negotiate in good faith a definitive license agreement (“Product License”), which
shall include * * * and other customary terms and conditions, wherein Noven grants
Shire a license to exclusively develop the Product with Noven under Noven
Intellectual Property Rights and Noven Arising Intellectual Property. If the
parties jointly (through their respective employees, agents or consultants) make or
conceive any inventions or discoveries or other intellectual property in the course
of the work to be performed pursuant to the Project, the ownership of such
inventions or discoveries or other intellectual property and any patent applications
and patents obtained thereon shall be governed by Section 13 below. * * *”
	 
	 	4.2.	 	* * *






	 	4.2.1.	 	* * *.
	 
	 	4.2.2.	 	* * *.






	5.	 	No Further Modification. The parties acknowledge and agree that this Amendment
constitutes an amendment to the Agreement in accordance with the terms and conditions hereof
and thereof. Except as specifically amended hereby, the Agreement shall remain in full force
and effect without any further amendments or modifications.
	 
	6.	 	Shire Payment. Within * * * of the date of this Amendment, Shire shall pay to Noven
one million dollars ($1,000,000) to an account specified in advance by Noven.
	 
	7.	 	Miscellaneous.






	 	7.1.	 	This Amendment shall be construed in accordance with and shall be governed by
the substantive laws of the State of Delaware, without giving effect to the conflict of
laws principles thereof.
	 
	 	7.2.	 	This Agreement shall become binding when any one or more counterparts hereof,
individually or in the aggregate, shall bear the signatures of the duly authorized
representatives of each of the parties hereto. This Amendment may be executed in any
number of counterparts, each of which shall be deemed an original as against the party
whose signature appears thereon, but all of which taken together shall constitute one
and the same instrument. Facsimile signatures of the authorized signatories of the
parties shall constitute due execution and delivery of this Amendment.




-3-









 






	 	7.3.	 	The terms of this Amendment shall not be amended, modified, varied or
supplemented except in writing signed by the duly authorized representatives of the
parties.
	 
	 	7.4.	 	No party shall have a right to assign their Agreement or delegate any of its
rights, interests, duties or obligations hereunder without the prior written consent of
the other party (which consent may be granted in such part’s sole discretion);
provided, however, that any party may assign this Agreement to any of its affiliates
without the prior written consent of the other party; and provided, further that no
such assignment of this Agreement shall relieve the assignor of any of its obligations
or liabilities under this Agreement. Notwithstanding the foregoing, any party may
assign this Agreement without the other parties’ prior written consent in connection
with the transfer or sale of all or substantially all of its assets or business or its
merger or consolidation with another Person upon written notice to the other parties.
This Amendment shall inure to the benefit of and be binding upon the parties hereto and
their successors and permitted assigns.
	 
	 	7.5.	 	If any provision of this Amendment shall be found by any court or
administrative body of competent jurisdiction to be invalid or unenforceable, the
invalidity or unenforceability of that provision shall not affect the other provisions
of this Amendment or the Agreement and all provisions hereof and thereof not affected
by the invalidity or unenforceability shall remain in full force and effect.
	 
	 	7.6.	 	This Amendment, together with the Agreement and the Transaction Agreement,
represents the entire agreement between the parties relating to the subject matter
hereof. Neither party shall have any obligation to the other party hereunder other
than as expressly set forth in this Amendment, the Agreement and the Transaction
Agreement.





     If you are in agreement with the terms and conditions set forth herein, please so indicate by
signing where indicated below and return an executed copy to me.



	 	 	 	 	 
	 	Very truly yours,

 	 
	 	/s/ Robert C. Strauss
 	 
	 	 	 
	 	Robert C. Strauss

President, CEO and Chairman 	 
	 




Acknowledged and agreed this

4th day of May, 2007:



SHIRE PHARMACEUTICALS IRELAND LIMITED




	 	 	 	 	 
	 	 	 
	/s/ Michael Cola
 	 
	By:  	 	 
	Title:  	 	 
	 




-4-