Exhibit 10.1
AMENDMENT NO. 2 TO JPPLP INTELLECTUAL PROPERTY TRANSFER
AND LICENSE AGREEMENT
This Amendment No. 2 (the “2nd JPPLP Amendment”) is made and entered into as of
May 12, 2005 by and between Janssen Pharmaceutica Products, L.P., a New Jersey
limited partnership having a principal place of business at 1123
Trenton-Harbourton Road, Titusville, New Jersey 08628 (hereinafter referred to
as “JPPLP”) and Barrier Therapeutics, Inc., a Delaware corporation having an
address at 600 College Road East, Suite 3200, Princeton, New Jersey 08540
(hereinafter referred to as “Barrier”).
WHEREAS, JPPLP and Barrier are parties to that certain Intellectual Property
Transfer and License Agreement dated May 6, 2002, as amended by an Amendment
No. 1 between JPPLP and Barrier dated September 7, 2004 (collectively, the
“JPPLP Agreement”);
WHEREAS, Barrier and Johnson & Johnson Consumer Companies, Inc., an Affiliate of
JPPLP (“JJCC”), are parties to a certain Intellectual Property Transfer and
License Agreement between Barrier and JJCC dated May 6, 2002, as amended by an
Amendment No. 1 between JJCC and Barrier dated September 7, 2004 (collectively,
the “JJCC Agreement”) under which Barrier obtained exclusive rights to the ‘683
Product (as defined in the JJCC Agreement) containing ketoconazole;
WHEREAS, JPPLP and JJCC believe that neither the JPPLP Agreement nor the JJCC
Agreement require JPPLP or JJCC to provide Barrier with authorization to
cross-reference JPPLP’s NDAs or INDs for Barrier’s development of a Ketoconazole
USP 2% Topical Gel;
WHEREAS, Barrier believes that one or both of the JPPLP Agreement and JJCC
Agreement, require JPPLP and/or JJCC to provide Barrier with authorization to
cross-reference JPPLP’s NDAs or INDs for Barrier’s development of a Ketoconazole
USP 2% Topical Gel; and
WHEREAS, in order to amicably resolve this disagreement, JPPLP and Barrier
desire to make further modifications to the JPPLP Agreement pursuant to the
terms of this 2nd JPPLP Amendment.
NOW, THEREFORE, in consideration of the above premises and the covenants
contained herein, the parties agree as follows:
1. Definitions. Capitalized terms used herein and not otherwise defined shall
have the meanings given to them in the JPPLP Agreement.
2. A new Section 3.3(g) is hereby added to the JPPLP Agreement to read in its
entirety as follows:

 

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     “(g) JPPLP shall provide Barrier with a letter authorizing the FDA (or if
requested, Health Canada) to reference the information contained in JPPLP’s NDA
Nos. 19-927, 19-084, 19-576, 19-648 and 18-533, and IND 31,783 (and any foreign
equivalents thereof in Canada) for preclinical, clinical, and chemistry and
manufacturing controls information on behalf of an IND No. 67,820 for the
Ketoconazole USP 2% Topical Gel set forth therein and the NDA (or DIN) in
connection therewith. Barrier acknowledges and agrees that JPPLP and its
Affiliates have no further obligation to provide any additional authorization to
reference their NDAs or INDs for any other product containing ketoconazole
(other than Barrier’s combination product containing ketoconazole and desonide).
3. Except as expressly amended herein, all terms and conditions of the JPPLP
Agreement shall remain in full force and effect.
4. All matters affecting the interpretation, validity, and performance of this
JPPLP Amendment shall be governed by the laws of the State of New York, USA,
without regard to its choice or conflict of law principles.
5. This 2nd JPPLP Amendment may be executed in one or more counterparts, each of
which shall for all purposes be deemed to be an original and all of which shall
constitute the same instrument. This 2nd JPPLP Amendment may be executed by
facsimile signature which shall have the same force and effect as the original
signatures.
     IN WITNESS WHEREOF, and intending to be legally bound, the parties hereto
have caused this JPPLP Amendment to be executed by their duly authorized
representatives as of the date first set forth above.
JANSSEN PHARMACEUTICA PRODUCTS, L.P.

         
By:
  /s/ JANET VERGIS    
 
       
 
        Print Name: Janet Vergis    
 
        Print Title: President    

BARRIER THERAPEUTICS, INC.

         
By:
  /s/ AL ALTOMARI    
 
       
 
        Print Name: Al Altomari    
 
        Print Title: Chief Commercial Officer    

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