Exhibit 10.27
March 6, 2006
Shire Pharmaceuticals Ireland Limited
6 Fitzwilliam Square
Dublin 2, Ireland

     
Re:
  Transaction Agreement, dated as of February 26, 2003, by and among Noven
Pharmaceuticals, Inc. (“Noven”), Shire US Inc. (“Shire US”) and Shire
Pharmaceuticals
Group plc (the “Transaction Agreement”)

Dear Sir/Madam:
     This letter agreement (together with the Exhibit hereto, this “Agreement”)
will serve to supplement and amend the following agreements:
     A. The Transaction Agreement, which was assigned to and assumed by Shire
Pharmaceuticals Ireland Limited (“Shire Ireland” and, together with Shire US,
“Shire”) pursuant to that certain Assignment and Assumption Agreement between
Shire US and Shire Ireland dated April 7, 2003,
     B. That certain letter agreement, dated April 28, 2004 (the “April 2004
Letter Agreement”) between Noven and Shire US acting on behalf of itself and its
affiliate Shire Ireland, and
     C. That certain letter agreement, dated June 15, 2004 (the “June 2004
Letter Agreement”) between Noven and Shire US acting on behalf of its affiliate,
Shire Ireland (which by its terms replaced that certain letter agreement, dated
November 5, 2003 between Noven and Shire US acting on behalf of its affiliate,
Shire Ireland).
     The Transaction Agreement, the April 2004 Letter Agreement and the June 15,
2004 Letter Agreement are referred to herein as the “Transaction Documents”.
     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, Noven and Shire Ireland hereby
agree as follow:
     1. Capitalized Terms. Capitalized terms used and not defined in this
Agreement shall have the meanings set forth in the Transaction Agreement.
     2. Reimbursement of Certain Known Costs. The parties acknowledge that Shire
has incurred certain costs in pursuit of regulatory approval of the transdermal
methylphenidate drug delivery system for which New Drug Application 21-514 (the
“Product NDA”) is currently pending, including, as described in Exhibit A, with
respect to the December 2, 2005 meeting of the FDA Psychopharmacologic Drugs
Advisory Committee and for certain clinical overruns. Noven hereby agrees to
reimburse Shire for the specific amounts listed in Exhibit A hereto.

 

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     Shire hereby represents and warrants to Noven that such amounts represent
not more than fifty percent (50%) of the amounts actually incurred by Shire and
paid or payable to third parties for the purposes described in Exhibit A. Shire
shall submit an invoice to Noven for the total amount set forth in Exhibit A,
together with supporting documentation for each expense. Noven shall pay such
invoice in full within thirty days (30) days of receipt.
     3. Reimbursement of Certain Resubmission Costs. The parties acknowledge
that Shire has and will incur certain costs related to the February 9, 2006
submission (the “Resubmission”) of an amendment to the Product NDA in response
to the December 2005 approvable letter received from the U.S. Food & Drug
Administration. Noven hereby agrees to reimburse Shire for fifty percent (50%)
of the reasonable out-of-pocket costs actually incurred by Shire and paid to
third parties for consulting and other services related to the Resubmission. The
parties acknowledge that total Resubmission costs are currently estimated to be
approximately $153,400 and agree that in no event shall Noven’s reimbursement
obligation under this Section 3 exceed $100,000. Shire shall submit invoices to
Noven monthly to the Noven finance contact listed below, together with
supporting documentation for each expense for which Shire seeks reimbursement;
provided that Shire shall review each third party invoice for accuracy before
submitting it to Noven. Shire’s review shall be conducted as if Shire were
solely responsible for payment of the invoice. Noven shall pay each invoice
received from Shire within thirty (30) days of receipt.
Accounts Payable
Noven Pharmaceuticals, Inc.
11960 SW 144th Street
Miami, Florida 33186
     4. Amendment to Shire’s Repurchase Right. Section 9.02(c) of the
Transaction Agreement is hereby amended to read as follow:
“If (i) at any time after the Closing Date Seller or Purchaser shall receive a
Non-Approval Notice, or (ii) Regulatory Approval shall not have been obtained by
the second anniversary of the Closing Date, then in either case, Purchaser shall
have the right to demand that Seller repurchase from Purchaser all of the
Purchased Assets transferred hereunder and terminate the license to the
Technology granted to Purchaser under the License Agreement, for an aggregate
consideration of US$4,000,000 and on other terms and conditions to be negotiated
by Seller and Purchaser in good faith; provided, that Purchaser shall provide
written notice of such demand within 90 days of the issuance of such
Non-Approval Notice or the second anniversary of the Closing Date, as the case
may be.”
     All references in the April 2004 Letter Agreement and the June 2004 Letter
Agreement to Shire’s rights under Section 9.02(c) of the Transaction Document
shall give effect to the amendment of Section 9.02 pursuant to this Agreement.
     5. Other. Noven’s reimbursement obligation under this Agreement shall be in
addition to its reimbursement obligations under the Transaction Documents. The
parties acknowledge and agree that this Agreement constitutes an amendment to
the Transaction

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Documents in accordance with the terms and conditions hereof and thereof. Except
as specifically amended hereby, the Transaction Documents shall remain in full
force and effect without any further amendments or modifications. This Agreement
shall be construed in accordance with and governed by the substantive laws of
the State of Delaware, without giving effect to the conflict of laws principles
thereof. This Agreement shall become binding when any one or more counterparts
hereof, individually or in the aggregate, shall bear the signatures of each of
the parties hereto. This Agreement 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 authorized
signatories of the parties shall constitute the due execution and delivery of
this Agreement. This Agreement shall inure to the benefit of and be binding upon
the parties hereto and their successors and permitted assigns. Any disputes
arising under this Agreement shall be resolved in accordance with the dispute
resolution mechanism provided in the Transaction Agreement.

            Very truly yours,
      /s/ ROBERT C. STRAUSS             Robert C. Strauss
President, CEO and Chairman     

ACKNOWLEDGED AND AGREED THIS
6th DAY OF March, 2006:

            SHIRE PHARMACEUTICALS IRELAND LIMITED
      /s/ JOHN R. LEE       By: John R. Lee      Title:   Director     

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