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] 
      

    
		 		
		Director
      or Secretary 		/s/ [ILLEGIBLE] 
      

    
		 		
	Executed
      as a deed by QUINTILES 

      IRELAND LIMITED:	)

      )		
		Director		/s/ [ILLEGIBLE] 
      

    
		 		
		Director
      or Secretary 		/s/ [ILLEGIBLE] 
      

    
		 		
	Executed
      as a deed by QUINTILES 

      TRANSNATIONAL CORP.:	)

      )		
		Director		/s/ [ILLEGIBLE] 
      

    
				
		Director
      or Secretary		/s/ [ILLEGIBLE] 
      

    


 
 





	 	
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	 Executed
      as a deed by BRADLEY 

      PHARMACEUTICALS, INC.:
      	
      )

        )

    	     	 
		Director
      		/s/ [ILLEGIBLE] 
      

    
	 	 	 	 
	 	Director
      or Secretary 	 	/s/ Iris S.
      Glassman
      

    
	 	 	 	 
	Executed as
      a deed by BDY ACQUISITION CORP.:	
      )

        )

    	 	 
	 	Director
      	 	/s/ [ILLEGIBLE] 
      

    
	 	 	 	 
	 	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] 
      

    
	 	 	 	 
	 	Director
      or Secretary 	 	/s/ Iris S.
      Glassman
      

    








	 	
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SCHEDULE 2 



Patent Rights 



“Treatment of
Conditions and Disease” - Solaraze I 




	
      

    
	Country	           	Application No.	           	Publication No.	           	Status	     
	
      

    
	Canada	 	612307	 	1340994	 	Granted	 
	
      

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

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

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

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

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

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

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

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

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

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

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

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

    






“Formulation
Containing Hyaluronic Acid” - Solaraze II 




	
      

    
	Country	           	Application No.	           	Publication No.	           	Status	     
	
      

    
	Canada	 	2061703	 	2061703	 	Granted	 
	
      

    
	Canada	 	2089621	 	 	 	Pending	 
	
      

    
	Mexico	 	930904	 	209917	 	Granted	 
	
      

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

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

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

    






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

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

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

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

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

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

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

    








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



	
      

    
	Country	           	Application No.	           	Publication No.	           	Status	     
	
      

    
	Canada	 	2061566	 	2061566	 	Granted	 
	
      

    
	Canada	 	2089635	 		 	Pending	 
	
      

    
	Mexico	 	930905	 		 	Pending	 
	
      

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

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

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

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

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

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

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

    






	 	
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