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:

(1) Jagotec hereby consents, acknowledges and agrees to the following:

  (a) QIreland may assign and transfer all of its rights and obligations under
the Licence Documents to the Buyer at the closing of the Transaction (the
“Assignment Date”); provided, such assignment and transfer shall not take place
prior to Jagotec receiving the payment referred to in clause 3 below and if for
any reason that date

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  of receipt is later than the date of the closing of the Transaction then that
later date shall be the Assignment Date:

  (i) the Buyer shall assume and be responsible for all liabilities and
obligations of QIreland arising after the Assignment Date, under the Licence
Documents;

  (ii) the Buyer shall have and enjoy all the rights and benefits of QIreland
under the Licence Documents including without limitation under Section 7.1 of
the Deed of Variation and Novation. For the avoidance of doubt, the Licence
Documents provide Buyer with ***;

  (iii) QIreland releases and discharges Jagotec from all its obligations and
liabilities to QIreland under the Licence Documents which accrue in respect of
acts or omissions of Jagotec after the Assignment Date;

  (iv) Jagotec releases and discharges QIreland from all its obligations and
liabilities to Jagotec under the Licence Documents which accrue in respect of
acts or omissions of QIreland after the Assignment Date;

  (v) QIreland shall cease to be a party, and the Buyer shall become a party, to
the Licence Documents with respect to all rights and obligations of QIreland
under the Licence Documents arising after the Assignment Date;

  (vi) Clause 11 and Schedule 1 of the Deed of Variation and Novation, regarding
a guarantee of Quintiles Transnational Corp., shall terminate and have no
further force or effect and shall not constitute an obligation of the Buyer; and

  (vii) the assignment and novation envisaged by this Deed shall not constitute
a “termination” within the meaning of Clause 5.7 of the Licence and
Manufacturing Agreement as amended in the Second Addendum;

  (b) The parties acknowledge and agree that:

  (i) any obligation of QIreland owed to Jagotec pursuant to the terms of the
Licence Documents which remain undischarged at the Assignment Date shall not be
deemed to be waived by Jagotec by virtue of Clause 1(a)(iv) and

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  shall remain obligations owed to Jagotec by QIreland, which for the avoidance
of doubt shall include all royalty obligations due from QIreland in respect of
any period prior to the Assignment Date; and

  (ii) any obligations of Jagotec owed to QIreland pursuant to the terms of the
Licence Documents which remain undischarged at the Assignment Date shall not be
deemed to be waived by QIreland by virtue of Clause 1(a)(iii) and shall remain
obligations owed by Jagotec to QIreland.

  (c) Notwithstanding clause 18 of the Licence and Manufacturing Agreement, the
Buyer shall be entitled to assign and transfer any and all of its rights and
obligations under the Licence Documents, without Jagotec’s consent, to an
Associated Company (as such term is defined in the Licence and Manufacturing
Agreement) of the Buyer, provided that prior written notice of such assignment
is given to Jagotec;

  (d) In the event that the Buyer shall have entered into any arrangement
pursuant to clause 1(c) above whereby the Buyer shall have assigned the benefit
of the Licence Documents to any Associated Company of the Buyer, the Buyer shall
not allow any transaction or event to take place whereby such Associated Company
shall cease to be an Associated Company of the Buyer without first ensuring that
the benefit of the Licence Documents shall prior to any such transaction or
event be assigned by such Associated Company to the Buyer or assigned to another
Associated Company of the Buyer;

  (e) In the event of an assignment pursuant to clause 1(c) or (d), this Deed
shall be binding upon such assignee but no such assignment or transfer shall
relieve the Buyer of any of, and the Buyer shall remain responsible for, its
obligations under the Licence Documents. In such circumstances the Buyer (or any
such other Associated Company, as the case may be, to which such benefit shall
be assigned) shall at the same time as any such assignment execute an agreement
in substantially the same terms as this Deed; and

  (f) The Licence Documents constitute all of the agreements, arrangements or
understandings with respect to the subject matter thereof; the Licence Documents
have not been amended or modified; the Licence Documents are in full force and
effect and, to the knowledge of Jagotec, QIreland and Quintiles are in
compliance with the Licence Documents and no breach or default has occurred
thereunder, and no event has occurred and no circumstance exists that would
constitute a breach or default.

(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

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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

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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:

  (a) the legality, validity or enforceability in that jurisdiction of any other
provision of this Deed; or

  (b) the legality, validity or enforceability in any other jurisdiction of any
other provision of this Deed.

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

  (a) may be exercised as often as necessary;

  (b) are cumulative and not exclusive of its rights under the general law;

  (c) may be waived only in writing and specifically; and

  (d) shall not be deemed waived solely by any delay in exercise or non-exercise
of any such right.

(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:

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  (a) in relation to Jagotec:

  SkyePharma Plc, 105 Piccadilly, London W1V 9FN for the attention of the
Company Secretary

  (b) in relation to the Buyer:

  The London Law Agency Limited, Temple Chambers, 84 Temple Chambers, London,
England EC4Y OHP for the attention of the Buyer’s Secretary

  (c) in relation to Quintiles:

  Quintiles Transnational Corp.
c/o Quintiles, Ltd.
Station House
Market Street, Bracknell, Berkshire RG12 1HX
      Attn: Alasdair MacDonald, Vice President of Legal and Quality Services

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]

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[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.

Executed as a deed by JAGOTEC AG:

)
)

        Director /s/ [ILLEGIBLE]

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  Director or Secretary /s/ [ILLEGIBLE]

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  Executed as a deed by QUINTILES
IRELAND LIMITED: )
) Director /s/ [ILLEGIBLE]

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  Director or Secretary /s/ [ILLEGIBLE]

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  Executed as a deed by QUINTILES
TRANSNATIONAL CORP.: )
) Director /s/ [ILLEGIBLE]

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Director or Secretary /s/ [ILLEGIBLE]

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Executed as a deed by BRADLEY
PHARMACEUTICALS, INC.:

)
)

        Director /s/ [ILLEGIBLE]

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          Director or Secretary   /s/ Iris S. Glassman

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        Executed as a deed by BDY ACQUISITION CORP.:

)
)

      Director   /s/ [ILLEGIBLE]

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          Director or Secretary   /s/ [ILLEGIBLE]

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SCHEDULE 1
The Guarantee

1. GUARANTEE

  Bradley Pharmaceuticals, Inc. (“Bradley”) irrevocably and unconditionally:

  (a) guarantees to Jagotec as principal obligor the due and punctual
performance and observance by the Buyer of all of its obligations under this
Deed; and

  (b) undertakes to indemnify Jagotec against all losses, damages, costs and
expenses incurred by Jagotec arising from any failure by the Buyer to perform
and/or observe any of its obligations under this Deed,

  (together this “Guarantee”).

2. CONTINUING SECURITY

  This Guarantee is to be a continuing security which shall remain in full force
and effect until all of the obligations of the Buyer under this Deed shall have
been fulfilled or shall have expired in terms of this Deed (which ever is the
sooner) and this Guarantee is to be in addition, and without prejudice to, and
shall not merge with any other right, remedy, guarantee, indemnity or security
which Jagotec may now or hereafter hold in respect of all or any of the
obligations of Buyer under this Deed.

3. JAGOTEC’S PROTECTIONS

  The liability of Bradley under this Guarantee shall not be affected, impaired
or discharged by reason of any act, omission, matter or thing which but for this
provision might operate to release or otherwise exonerate Bradley from its
obligations hereunder including, without limitation:

  (a) any amendment, variation or modification to, or replacement of this Deed,

  (b) the taking, variation, compromise, renewal, release, refusal or neglect to
perfect or enforce any rights, remedies or securities against the Buyer or any
other person;

  (c) any time or indulgence or waiver given to, or composition made with the
Buyer or any other person; or

  (d) the Buyer becoming insolvent, going into receivership or liquidation or
having an administrator appointed.

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4. FURTHER PROTECTION

  This Guarantee shall continue in full force and effect notwithstanding:

  (a) that any purported obligation of the Buyer or any other person to Jagotec
(or any security therefor) becomes wholly or partly void, invalid or
unenforceable for any reason whether or not known to Jagotec or Bradley; or

  (b) any incapacity or any change in the constitution of, or any amalgamation
or reconstruction of, the Buyer or Bradley or any other matter whatsoever.

5. PRIMARY OBLIGATIONS

  This Guarantee shall constitute the primary obligations of Bradley and Jagotec
shall not be obliged to make any demand on the Buyer before enforcing its rights
against Bradley under this Guarantee.

6. WAIVER

  No delay or omission of Jagotec in exercising any right, power or privilege
under this Guarantee shall impair such right, power or privilege or be construed
as a waiver of such right, power or privilege nor shall any single or partial
exercise of any such right, power or privilege preclude any further exercise
thereof or the exercise of any other right, power or privilege.

7. INVALIDITY

  If at any time any one or more of the provisions of this Guarantee is or
becomes invalid, illegal or unenforceable in any respect under any law, the
validity, legality and enforceability of the remaining provisions hereof shall
not be in any way affected or impaired thereby.

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8. CHOICE OF LAW

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

Executed as a deed by BRADLEY
PHARMACEUTICALS, INC. on
August 4, 2004:

)
)

        Director /s/ [ILLEGIBLE]

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          Director or Secretary   /s/ Iris S. Glassman

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SCHEDULE 2

Patent Rights

“Treatment of Conditions and Disease” - Solaraze I

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Country             Application No.             Publication No.            
Status      

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Canada   612307   1340994   Granted  

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USA   08/465,335   5,811,410   Granted  

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USA   08/286,263   5,827,834   Granted  

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USA   08/462,615   5,830,882   Granted  

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USA   08/462,147   5,852,002   Granted  

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USA   08/462,614   5,914,314   Granted  

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USA   08/462,148   5,929,048   Granted  

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USA   08/461,124   5,932,560   Granted  

--------------------------------------------------------------------------------

USA   08/462,154   5,985,850   Granted  

--------------------------------------------------------------------------------

USA   08/744,852   5,985,851   Granted  

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USA   08/461,565   6,048,844   Granted  

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USA   07/675,908   6,069,135   Granted  

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USA   08/460,978   6,194,392   Granted  

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“Formulation Containing Hyaluronic Acid” - Solaraze II

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Country             Application No.             Publication No.            
Status      

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Canada   2061703   2061703   Granted  

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Canada   2089621       Pending  

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Mexico   930904   209917   Granted  

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USA   08/467,171   5,942,498   Granted  

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USA   08/467,995   5,977,088   Granted  

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USA   08/466,713   5,990,096   Granted  

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USA   08/018,754   6,103,704   Granted  

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USA   08/352,697   6,114,314   Granted  

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USA   08/466,714   6,140,312   Granted  

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USA   08/467,994   6,218,373   Granted  

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USA   08/468,330   6,147,059   Granted  

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USA   08/474,732   6,087,344   Granted  

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USA   08/466,715   6,136,793   Granted  

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

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Country             Application No.             Publication No.            
Status      

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Canada   2061566   2061566   Granted  

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Canada   2089635     Pending  

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Mexico   930905     Pending  

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USA   07/838,675   5,639,738   Granted  

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USA   08/018,508   5,792,753   Granted  

--------------------------------------------------------------------------------

USA   08/468,329   5,824,658   Granted  

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USA   08/290,848   5,910,489   Granted  

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USA   08/466,774   5,914,322   Granted  

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USA   08/466,778   5,962,433   Granted  

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USA   08/466,775   6,017,900   Granted  

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