Deed of Consent and Novation among Jagotec AG, Quintiles, Quintiles Ireland, Bradley Pharmaceuticals, and BDY Acquisition Corp.

Exhibit 10.5.4

Confidential portions of this document have been omitted and filed separately with the Commission. The omitted portions have been marked as follows: “***”.

Confidential

DEED OF CONSENT AND NOVATION

        This Deed of Consent and Novation (this “Deed”) is entered into as of August 4, 2004 among Jagotec AG (“Jagotec”), Quintiles Transnational Corp. (“Quintiles”), Quintiles Ireland Limited, an affiliate of Quintiles (“QIreland”), Bradley Pharmaceuticals, Inc. (“Bradley”) and BDY Acquisition Corp. (the “Buyer”), a wholly-owned subsidiary of Bradley.

Recitals

A. Jagotec and Bioglan Pharma Plc entered into the Licence and Manufacturing Agreement dated March 13, 2000 (the “Licence and Manufacturing Agreement”) regarding a pharmaceutical product known as Solaraze^®;

B. Jagotec and Bioglan Pharma Plc entered into the Addendum Agreement dated December 28, 2000 (the “Addendum Agreement”);

C. Jagotec, Bioglan Pharma Plc and QIreland entered into the Second Addendum dated December 20, 2001 (the “Second Addendum”);

D. Jagotec, Bioglan Pharma Plc, Bioglan Pharma Inc. (now known as BPI New Corp.), QIreland and Quintiles entered into the Deed of Variation and Novation dated December 20, 2001 (the “Deed of Variation and Novation”) (the Licence and Manufacturing Agreement, the Addendum Agreement, the Second Addendum, and the Deed of Variation and Novation are collectively referred to in this Deed as the “Licence Documents”);

E. Bioglan Pharmaceuticals Company, an affiliate of Quintiles, and QIreland plan to transfer and sell certain assets to the Buyer, a company organized under the laws of Delaware, U.S.A. (the “Transaction”);

F. In connection with the Transaction, Quintiles and its affiliates have requested that Jagotec consent to the transfer of the Licence Documents to the Buyer and agree to certain matters as set forth in this Deed; and

G. Jagotec agrees to consent to certain other matters on the terms set forth in this Deed.

NOW, THEREFORE, the parties agree as follows:

(2) Without limiting the provisions of the Licence Documents in any manner, Jagotec confirms and agrees that the term “Patent Rights” as defined in the Addendum Agreement

includes the patents and patent applications as shown in the attached schedule 2, and that Jagotec is owner of such patents and patent applications.

(3) In consideration for Jagotec consenting to the assignment and novation of the Licence Documents to the Buyer, Quintiles agrees to pay to Jagotec a consent fee of Five Million United States Dollars (US $5,000,000) at or prior to the closing of the Transaction. Prior to execution of this Deed, QIreland’s obligation to pay all royalties and other fees under the Licence Documents due in respect of sales in 2001, 2002, 2003 and the first quarter of 2004 has been fulfilled. There is no known outstanding dispute with respect to royalties or other fees under the Licence Documents. However, no royalty audit pursuant to Clause 4.4 of the Licence and Manufacturing Agreement has yet taken place and the statements made in this clause are without prejudice to Jagotec’s rights pursuant to the Licence and Manufacturing Agreement including those contained in Clause 4.4

(4) Prior to or following the Assignment Date, each party agrees to execute and deliver such other agreements, documents and instruments, and to do and take such other acts or actions, as any other party to this Deed shall reasonably request for the purpose of carrying out the intent of this Deed, including without limitation in order to carry out or further evidence the assignment and transfer of all of QIreland’s right, title and interest in, to and under Licence Documents to the Buyer.

(5) This Deed shall be binding upon the parties hereto and their successors and assigns and shall inure to the benefit of such parties and their permitted successors and assigns. The parties do not intend that any term of this Deed shall be enforceable solely by virtue of the Contracts (Rights of Third Parties) Act 1999 by any person who is not a party to this Deed.

(6) This Deed may be executed in any number of counterparts, each of which when executed and delivered shall be deemed to be an original and all of which counterparts taken together shall constitute one and the same instrument. The exchange of copies of this Deed and of executed signature pages by facsimile transmission or by email transmission in portable digital format, or similar format, shall constitute effective execution and delivery of this Deed. Signatures of the parties transmitted by facsimile, or by email in portable digital or similar format shall be deemed to be their original signatures for all purposes.

(7) In consideration of Jagotec entering into this Deed, Bradley hereby gives in favour of Jagotec the guarantee in the terms set out in schedule 1.

(8) Each party to this Deed represents and warrants to the other parties that: (a) it is duly organized, validly existing, and in good standing under the laws of the jurisdiction in which it is organized, with full corporate power and authority to execute, deliver and perform this Deed; and (b) this Deed constitutes the legal, valid and binding obligation of it, enforceable against it in accordance with the terms of this Deed. Jagotec represents and warrants to the other parties that it is an Associated Company of SkyePharma Plc. The Buyer and Bradley represents and

warrants to the other parties that the Buyer is an Associated Company of Bradley, and that the Buyer is incorporated in the U.S.A.

(9) If any provision of this Deed is or becomes illegal, invalid or unenforceable in any jurisdiction, that shall not affect:

(10) The rights of each party under this Deed:

(11) This Deed constitutes the entire agreement relating to the subject matter of this Deed and supersedes all prior negotiations, documents, agreements, statements and understandings.

(12) In the event that the Buyer or other party shall have entered into any arrangement pursuant to clause 1(c) whereby the Buyer shall have assigned the benefit of the Licence Documents to any Associated Company of the Buyer or pursuant to clause 1(d) and such assignment results in any set off or deduction whatsoever including, without limitation, any deduction of taxes, charges or other duties that may be required by law, the sums paid under this Deed or under the Licence Documents shall be grossed up such that the payment made shall be as if it had been made in full without any such set-off or deduction provided that Jagotec agrees to cooperate in taking all reasonably necessary steps to take advantage of all double taxation treaties that may be available.

(13) This Deed is governed by and shall be construed in accordance with English law.

(14) The parties agree that the courts of England shall have jurisdiction to settle any disputes which may arise in connection with this Deed and that any judgment or order of an English court in connection with this is conclusive and binding on them and may be enforced against them in the courts of any other jurisdiction.

(15) Jagotec, Quintiles, and the Buyer undertake to, at all times, maintain an agent for service of process in England. Such agent shall be:

or such other address as is notified hereunder to the other of such parties in writing. Further, each of Jagotec, Quintiles, and the Buyer undertake not to revoke the authority of the above and, if for any reason any such agent no longer serves as agent for them, they shall promptly appoint another such agent and advise the other parties accordingly.

[signature page follows]

[Signature page to Deed of Consent and Novation]

IN WITNESS WHEREOF, the parties hereto, through their respective authorized representatives below, have duly executed and delivered this document as a Deed as of the date set forth above.

SCHEDULE 1
The Guarantee

This Deed is governed by and shall be construed in accordance with English law.

SCHEDULE 2

Patent Rights

“Treatment of Conditions and Disease” - Solaraze I

“Formulation Containing Hyaluronic Acid” - Solaraze II

“Treatment of Disease Employing Hyaluronic Acid and NSAIDs” - Solaraze III