Document:

Exhibit 10.5.3 

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

		
	DATED	 	2001
	
      

    

		
	         JAGOTEC
      AG	 	(1)
	 	 	
	       BIOGLAN
      PHARMA PLC	 	(2)
	 	 	
	       BIOGLAN
      PHARMA INC	 	(3)
	 	 	
	     QUINTILES
      IRELAND LIMITED	 	(4)
	 	 	
	QUINTILES TRANSNATIONAL CORP	 	(5)

DEED OF VARIATION
AND NOVATION 

 

	  page
      49 

 

THIS DEED
  is dated ..............................................2001 and is made BETWEEN:
  

	       (1)  	  	JAGOTEC
      AG of Eptingerstrassc 51, CH-4132 Muttenz, Switzerland (“Jagotec”);
      

	        (2)  	  	BIOGLAN
      PHARMA PLC registered in England with number 1779870 whose registered
      office is at 5 Hunting Gate, Hitchin, Hertfordshire, OTJ 0TW (“Bioglan”);
      

	        (3)  	  	BIOGLAN
      PHARMA INC. a company incorporated in Delaware whose registered office
      is situated 1013 Center Road, City of Wilmington, New Castle, 19805 Delaware,
      United States of America (“Inc”); 

	        (4)  	  	QUINTILES IRELAND
      LIMITED a company incorporated in the Republic of Ireland with number
      162942 whose registered office is situated  at East Point Business Park, Fairview,
      Dublin 3, Ireland (“Quintiles”); 

	        (5)  	  	QUINTILES TRANSNATIONAL
      CORP a company incorporated in North Carolina whose office is situated
      at 4709 Creekstone Drive, Suite 200, Durham, NC 27703, United States of
      America (“Q”) 

WHEREAS: 

	      (A)  	  	By a Licence and
      Manufacturing Agreement dated 13 March 2000 (the “Licence”) Jagotec
      licensed Bioglan the manufacture and exploitation of a product known as
      Solaraze® in various European countries. 

	       (B)  	  	By an addendum
      agreement dated 28 December 2000 to be read in conjunction with the Licence,
      Jagotec granted a further licence to manufacture and exploit Solaraze®
      in the Additional Territory (the “First Addendum”). Further arrangements
      were made in relation to the Licence and the First Addendum by way of a
      letter dated 14 May 2001, by “Amendment no 1” dated 27 June 2001,
      by way of letter dated 4 October 2001, by way of letter dated 20 November
      2001 and by way of a Second Addendum of even date (the “Second Addendum”).
      

	       (C)  	  	This
Deed sets out the terms and conditions upon which Quintiles            shall be
substituted for Bioglan in relation to rights and            obligations of Bioglan under
the Licence, the First Addendum (as            amended) and the Second Addendum insofar
as they relate to the            Additional Territory. Q has agreed to guarantee the
performance and            the obligations of Quintiles under the aforesaid agreements. 

IT IS HEREBY
  AGREED as follows: 

	       I.  	  	Definitions
and Interpretation 

	       1.1  	  	In
this Deed, unless the context otherwise requires: 

	  	 “Additional
      Territory” means the United States of America (the “USA”),
      Canada and Mexico; 

	  	 “Business
      Day” means a day (other than a Saturday and a Sunday) on which
      banks are open for business in London. 

 

	  page
      50 

	  	 “Effective
      Time” means the time and date of execution hereof. 

	  	 “US Licence”
      means the rights and obligations of Bioglan under the Licence, the First
      Addendum (as amended) and the Second Addendum insofar as they relate to
      the Additional Territory. 

	        1.2  	  	In
this Deed, unless the context otherwise requires: 

	(a)  	  	references
      to clauses are to be construed as references to the clauses to this Deed,
      references to sub-clauses shall unless otherwise specifically stated be
      construed as references to the sub-clauses of the clause in which the reference
      appears; 

	(b)  	  	references
      to this Deed (or to any specified provisions of this Deed) or any other
      document shall be construed as references to this Deed, that provision or
      that document as in force for the time being and as amended, novated or
      supplemented in accordance with its terms, or, as the case may be, with
      the agreement of the relevant parties; 

	(c)  	  	words importing
      the plural shall include the singular and vice versa; 

	(d)  	  	references
      to a person shall be construed as including references to an individual,
      firm, company, corporation, unincorporated body of persons or any state
      or any agency thereof, 

	(e)  	  	references
      to any statute or statutory provision include any statute or statutory provision
      which amends, extends, consolidates or replaces the same, or which has been
      amended, extended, consolidated or replaced by the same, and shall include
      any orders, regulations, instruments or other subordinate legislation made
      under the relevant statute; 

	(f)  	  	the words
      other and otherwise shall not be construed ejusdem generis with any foregoing
      words where a wider construction is possible; 

	(g)  	  	the words
      including and in particular shall be construed as being by way of illustration
      or emphasis only and shall not be construed as, nor shall they take effect
      as, limiting the generality of any foregoing words. 

	       2.  	  	Consideration 

	  	 In consideration
      of the parties entering into this Deed Quintiles shall pay the sum of *** to Bioglan or to such nominee as directed
      by Bioglan. 

	      3.  	  	Variation 

	  	
With
effect from (and including) the Effective Time the Licence, the            First Addendum
(as amended) and the Second Addendum shall be treated            such that they shall
operate as separate agreements, one between            Quintiles and Jagotec in respect
of the Additional Territory and one            between Bioglan and Jagotec in respect of
the territories licensed            pursuant to the Licence. 

	      4.  	  	Novation 

 

	  Page
      51 

	4.1  	  	With
effect from (and including) the Effective Time, Bioglan hereby         novates the US
Licence to QUINTILES and Jagotec consents to such         novation upon the following
terms and conditions: 

	(a)  	  	Bioglan releases
      and discharges Jagotec from all its obligations and liabilities to Bioglan
      under the US Licence which accrue in respect of acts or omissions of Jagotec
      from and after the Effective Time; 

	(b)  	  	Jagotec releases
      and discharges Bioglan from all its obligations and liabilities to Jagotec
      under the US Licence which accrue in respect of acts or omissions of Bioglan
      from and after the Effective Time; 

	(c)  	  	QUINTILES
      undertakes with Jagotec on and with effect from and after the Effective
      Time to perform the obligations and assume the liabilities of Bioglan accruing
      from and after the Effective Time under or in connection with the US Licence
      in all respects as if QUINTILES had been named as a party thereto in place
      of Bioglan; Provided always that any notices of termination served by Jagotec
      against Bioglan before the Effective Time shall not be effective notices
      of termination with respect to Q’s right to exploit Solaraze in the
      Additional Territory from and after the Effective Time; 

	(d)  	  	QUINTILES
      shall be entitled to all of the rights and benefits of Bioglan under the
      US Licence which accrue from and after the Effective Tune, so that QUINTILES
      shall be substituted in place of Bioglan as a party to the US Licence and
      from and after the Effective Time the US Licence shall be construed and
      treated, and Jagotec and QUINTILES shall have rights and obligations under
      the US Licence in all respects, as if QUINTILES was named therein instead
      of Bioglan and all references to Bioglan shall be construed as references
      to Q. 

	4.2  	  	The
parties acknowledge and agree that: 

	(a)  	  	Any obligations
      of Bioglan owed to Jagotec pursuant to the terms of the US Licence which
      remain undischarged at the Effective Time shall not be deemed to be waived
      by Jagotec by virtue of clause 4.1 and shall remain obligations owed to
      Jagotec by Bioglan; 

	(b)  	  	Any obligations
      of Jagotec owed to Bioglan pursuant to the terms of the US Licence which
      remain undischarged at the Effective Time shall not be deemed to be waived
      by Bioglan by virtue of Clause 4.1 and shall remain obligations owed by
      Jagotec to Bioglan. 

	5.  	  	Licence
Continuation 

	  	
Nothing
in this Deed shall affect the Licence in the territories licensed thereunder. 

	6.  	  	Intellectual
Property and Technical information 

	6.1  	  	Pursuant
      to a Trade Mark Licence dated 27 November 2001 between Jagotec and Bioglan
      (the “Trade Mark Licence”), Jagotec agreed to assign trade
      mark applications for Solaraze®
       in the
      USA and Canada to the Bioglan and pending such assignment to license such
      marks to Bioglan. Bioglan and Inc hereby assign to Quintiles with full title
      guarantee:  

	(a)  	  	all trade
      mark registrations for the mark Solaraze® 
      (and applications therefor) in the USA Mexico and Canada owned by Bioglan
      and Inc; and 

 

	  page
      52 

	(b)  	  	insofar as
      Bioglan and Inc are not the proprietor of trade mark registrations for the
      mark Solaraze®
      (and applications therefor) in the USA and Canada at the date of this Deed,
      the Trade Mark Licence in respect of such marks shall be novated on the
      same terms (mutatis mutandis) as set out in clause 4.1 and 4.2. 

	 6.2  	  	To the extent
      that Bioglan and/or Inc have developed any intellectual property rights
      in the Solaraze® 
       product
      or its method of marketing or manufacture or Technical Information (as defined
      in the Licence), Bioglan and Inc hereby grant to Quintiles with effect from
      the date of this Deed an irrevocable, royalty-free, fully paid up, perpetual,
      non-exclusive fully assignable and sublicensable licence to use such intellectual
      property rights and Technical Information in the Additional Territory. 
    

	 6.3  	  	Inc hereby
      undertakes upon the request of Quintiles to transfer to Quintiles (or as
      it shall direct) all its right title and interest in the marketing authorization
      in the United States in respect of the Solaraze® 
      product including the NDA21-005 (the “NDA”) and all electronic
      and other documents relating to the NDA including the dossier of documents
      relating to its filing. 

	 6.4  	  	Quintiles
      and Inc. will, use their reasonable endeavours prior to 31st January 2002
      to agree in good faith the terms of an agreement to commercialize the Solaraze® 
      product in the Additional Territory for a minimum period of one year and
      reflecting the terms set out in the Appendix hereto. Inc. shall, pending
      formal agreement of the terms of a commercialization agreement, continue
      to commercialise and market the product on the basis that it is currently
      doing, but as agent for Quintiles, and will be compensated for such agency
      services in accordance with the terms of the final agreement, and Quintiles
      shall receive the benefit of Inc.’s commercialisation and marketing
      efforts. 

	 7  	  	Indemnity 

	 7.1  	  	With effect
      from the date of this Deed in the event that *** or *** brings legal proceedings
      alleging that Quintiles in the exercise of the rights licensed to it under
      the US Licence has infringed any of their intellectual property rights in
      any way whatsoever (a “Claim”) then Jagotec shall defend Quintiles
      on the following terms: 

	(a)  	  	Jagotec hereby
      fully and effectively indemnifies Quintiles against all damages and costs
      arising from a Claim awarded against Quintiles in a final judgment of a
      court of competent jurisdiction (or, subject to the provisions of this Deed,
      agreed by Jagotec by way of settlement), strictly on the condition that
      Quintiles: 

	  	(i)  	  	promptly notifies
      Jagotec of the Claim; 

	  	(ii)  	  	permits Jagotec
      the exclusive right to conduct in its own name the defence of any such Claim
      instead of Quintiles and to take any step in such Claim or to compromise
      such Claim on such terms as Jagotec in its sole discretion shall deem fit;
      

 

	  page
      53 

	  	(iii)  	  	sign any and all
      such documents and do all such acts as Jagotec may reasonably require in
      relation to such Claim for the purposes of such conduct or compromise; 

	  	(iv)  	  	provide Jagotec
      (and such others as it may require), with such reasonable assistance in
      relation to such Claim, including access to documents and to individuals,
      as Jagotec may reasonably request; 

	  	(v)  	  	take no action
      in such Claim, nor make any statement, nor compromise or seek to compromise
      them, except with Jagotec’s prior written consent which shall not be
      unreasonably withheld or delayed; 

	  	(vi)  	  	take all reasonable
      steps to mitigate Quintiles’ losses in respect of or as a consequence
      of the Claim; 

	  	
and
provided that such infringement is not caused by or               contributed to by any
act of Quintiles which would constitute a               breach of the US License. 

	(b)  	  	Save where
      expressly stated in Clause 6 or this Clause 7.1(b) the terms of the US License
      shall apply and remain in full force and effect in respect of the Additional
      Territory and, in particular, Jagotec’s obligation to provide written
      declarations of non-infringement from *** and *** as contained in Clause
      4.1 of the Licence and Clause A6-4 of the US Licence shall remain in full
      force and effect. Nothing contained in the indemnity set out in clause 7.1(a)
      above shall be deemed to waive any of Quintiles’ rights in respect
      of the US License. 

	(c)  	  	The indemnity
      set out in clause 7.1(a) above shall take effect from the Effective Time
      without the need for the Borrower or Inc. to take any further action whatsoever
      and shall continue until the date on which Quintiles has received the Declarations
      of Non-Infringement referred to in clause 7.1(b) above. 

	        7.2  	  	Jagotec
acknowledges that this Deed shall not constitute an “expiration” of the Licence
for the purposes of Clause                5.7 of the Licence. 

	        8.  	  	Miscellaneous 

	        8.1  	  	If any provision
      of this Deed is or becomes illegal, invalid or unenforceable in any jurisdiction
      that shall not effect: 

	  	(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 that any other provision
      of this Deed. 

	        8.2  	  	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; 

 

	  page
      54 

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

	  	(d)  	  	delay in exercising
      or non-exercise of any such right is not a waiver of that right. 

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

	        8.4  	  	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. 

	        8.5  	  	This
Deed may be executed in any number of counterparts and all such counterparts taken
together shall be deemed to                 constitute one instrument. 

	        8.6  	  	Notwithstanding
clause 18 of the Licence Agreement Quintiles                 shall be entitled to assign
the US Licence to an Associated                 Company of Quintiles provided that Q
guarantees the performance                 of its obligations under the US Licence by
such Associated                 Company. 

	        8.7  	  	All sums due under
      the US Licence shall be made in full without any set-off or deduction whatsoever
      including without limitation any deduction of taxes, charges or other duties
      that may be imposed except as required by law and, if so required, sums
      paid under the US License shall be grossed up so 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 all respects reasonably necessary to
      take advantage of all double taxation treaties that may be available. 

	        8.8  	  	The parties agree
      that they will at the request and expense of a party (the “Requesting
      Party”) promptly perform all acts and/or execute such other documents
      as are reasonably necessary in order to effect the provisions of this Deed
      and the Second Addendum. 

	        9.  	  	Representation 

	        9.1  	  	Bioglan
hereby represents to Quintiles that there are no other                 agreements between
the parties which may affect the exploitation                 of the SOLARAZE product by
Quintiles is the Additional Territory                 which are not mentioned in this
Deed or which have not otherwise                 been disclosed to Quintiles. 

	        9.2  	  	Jagotec
hereby represents to Quintiles that there are no other                 agreements between
the parties which may affect the exploitation                 of the SOLARAZE product by
Quintiles in the Additional Territory                 which are not mentioned in this
Deed or which have not otherwise                 been disclosed to Quintiles. 

	        9.3  	  	Jagotec hereby
      represents to Quintiles that agreement(s) have been reached between Jagotec
      and *** which preclude *** or *** from making any Claim (as defined in Clause
      7.1 above) against Jagotec or its sublicensee (including on and after the
      Effective Time) Quintiles relating to the Solaraze product in the Additional
      Territory. 

	        10.  	  	Law
and Jurisdiction  

	10.1  	  	Law 

 

	  page
      55 

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

	10.2 	  	Jurisdiction 

	  	
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         Deed is conclusive and binding
on them and may be enforced against them         in the courts of any other jurisdiction.
However, nothing in this Clause         shall limit the right of Bioglan and/or Inc to
bring proceedings against         Quintiles and/or Jagotec in connection with this Deed
in any court of         competent jurisdiction nor shall the taking of proceedings in one
or         more jurisdictions preclude the taking of proceedings in any other
        jurisdiction, whether concurrently or not. 

	10.3  	  	Agent
for Service 

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

	  	        (a)  	  	in
relation to Jagotec: 

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

	  	        (b)  	  	in
relation to Inc. 

	  	
Bioglan
Pharma PLC, 5 Hunting Gate, Hitchin, Hertfordshire 6TJ OTW for the attention of the
Company Secretary 

	  	        (c)  	  	in
relation to Q or to Quintiles: 

	  	
CMS
Cameron McKenna, 160 Aldersgatc Street, London ECIA 4DD for the attention of Mitre
Secretaries. 

	  	 or such other
      address as is notified to the other parties in writing. Further, each of
      Jagotec and Quintiles 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. 

	11.  	  	GUARANTEE 

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

 

	  page
      56 

SCHEDULE I 

The Guarantee 

	 I.  	  	Guarantee
      

	 1.1  	  	Q
irrevocably and unconditionally: 

	  	(a)  	  	guarantees
to Jagotec as principal obligor the due and punctual performance and observance by
Quintiles 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 Quintiles 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 Quintiles under this Deed shall have been
      fulfilled or shall have expired in accordance with the 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 Quintiles under this Deed.
      

	3.  	  	Jagotec’s
      Protections 

	3.1  	  	The
liability of Q 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 Q 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 Quintiles or any other person; 

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

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

	4.  	  	Further Protection
      

	4.1  	  	This
Guarantee shall continue in full force and effect notwithstanding. 

 

	  Page
      57 

	  	               (a)  	  	that any purported
      obligation of Quintiles 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 Q; or 

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

	        5.  	  	Primary Obligations
      

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

 

	  Page
      58 

IN WITNESS whereof the parties have
executed this document as a Deed on the day and year first before written. 

		
	EXECUTED as a Deed by	)	 
	JAGOTEC AG	)	/s/
      

    
	                             	) 	Director
	                             	) 	 /s/

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	BIOGLAN PHARMA PLC	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	BIOGLAN PHARMA INC	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	QUINTILES IRELAND LIMITED	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	QUINTILES TRANSNATIONAL CORP	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

 

	  page
      59 

 
IN WITNESS whereof the parties
  have executed this document as a Deed on the day and year first before written.
  

		
	EXECUTED as a Deed by	)	 
	JAGOTEC AG	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	BIOGLAN PHARMA PLC	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	BIOGLAN PHARMA INC	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	QUINTILES IRELAND LIMITED	)	 /s/

      

    
	                             	) 	Director
	                             	) 	 /s/

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	QUINTILES TRANSNATIONAL CORP	)	 /s/

      

    
	                             	) 	Director
	                             	) 	 /s/

      

      Director/Secretary

	  page
      60 

 
IN WITNESS whereof the parties
  have executed this document as a Deed on the day and year first before written.
  

		
	EXECUTED as a Deed by	)	 
	JAGOTEC AG	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	BIOGLAN PHARMA PLC	)	 /s/

      

    
	                             	) 	Director
	                             	) 	 /s/

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	BIOGLAN PHARMA INC	)	 /s/

      

    
	                             	) 	Director
	                             	) 	 /s/

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	QUINTILES IRELAND LIMITED	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

		
	EXECUTED as a Deed by	)	 
	QUINTILES TRANSNATIONAL CORP	)	 

      

    
	                             	) 	Director
	                             	) 	 

      

      Director/Secretary

 

 

	  page
      61 

Appendix 

Term Sheet — Solaraze®/PharmaBio
Commercialization of Solaraze 

Overview: Quintiles
  will acquire commercialization rights to Solaraze® in North America. Bioglan
  will provide “turn key” services to Quintiles in support of such commercialization
  activities, upon the terms and conditions outlined below. 

	1.  	  	Structure
of the Service Relationship 

	  	a.  	  	Overview  

		•		Quintiles
 will contract with Bioglan for “turn key” services to commercialize
Solaraze®; from an operational perspective, this structure is intended to operate in the
same manner, and utilizing all internal resources and infrastructure, as products owned
directly by Bioglan (and, indeed, the same resources/infrastructure currently being
utilized by Bioglan in support of the launch of Solaraze®); 

		•		Quintiles
will supplement Bioglan’s services       with resources from Quintiles’ commercialization
divisions; for example,       Quintiles will contribute additional sales representatives
to support the       launch of Solaraze®  (which sales representatives will be managed by
the Bioglan       team) such services to be paid for by Quintiles;

		•		The
parties will establish a Joint Steering Committee (JSC) to oversee the relationship
between Bioglan and Quintiles.

	  	b.  	  	Bioglan
Services and Relationship 

	•		Bioglan will have overall responsibility for managing
      all aspects of the commercialization of Solaraze®; specific activities will
      be provided by third parties (e.g. manufacturing and distribution) and Quintiles
      (e.g. supplemental sales representatives) Quintiles will pay for all sales
      and promotional activities for Solaraze®;

	•		Bioglan will be paid through (i) a “cost plus”
      fee on the infrastructure supporting the commercialization of the products,
      (ii) a “cost plus” contribution to the Bioglan sales force (e.g.
      ***% of the costs assuming Solaraze®  is detailed in the P1 detailing position);
      (iii) a merit based royalty payment tied to sales of the products; cost
      allocations for infrastructure will be agreed upon with a philosophy of
      “materiality” and reviewed regularly by the JSC to ensure equity;
      the pricing for Bioglan’s services is expected to accelerate Bioglan’s
      overall profitability;

	•		Bioglan shall promote Bioglan owned products along
      side Solaraze®; the detailing position for the respective parties and cost
      contribution for Bioglan owned products will be agreed upon by the parties.

	  	c.  	  	Third
Party Services 

	•		Quintiles will contract for ancillary services
      relating to the commercialization of the products (or alternatively B will
      contract with these parties), e.g. manufacturing and distribution;

	•		B will manage the relationship with the third parties.

 

	  Page
      62Exhibit 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 

	 	
1
of 13	 

	  	
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 

	 	
2
of 13	 

	  	
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 

	 	
3
of 13	 

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 

	 	
4
of 13	 

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: 

	 	
5
of 13	 

	   	
          (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]  

	 	
6
of 13	 

[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] 
      

    

 
 

	 	
7
of 13	 

 
	 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] 
      

    

	 	
8
of 13	 

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. 

	 	
9
of 13	 

	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. 

	 	
10
of 13	 

	 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
      

    

	 	
11
of 13	 

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	 
	
      

    

	 	
12
of 13	 

	 	           	 	           	 	           	 	     
	
      

    
	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	 
	
      

    

	 	
13
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