AMENDMENT NO. 2 TO JPPLP INTELLECTUAL PROPERTY TRANSFER AND LICENSE AGREEMENT
Exhibit 10.1
AMENDMENT NO. 2 TO JPPLP INTELLECTUAL PROPERTY TRANSFER
AND LICENSE AGREEMENT
AND LICENSE AGREEMENT
This Amendment No. 2 (the “2nd JPPLP Amendment”) is made and entered into as of
May 12, 2005 by and between Xxxxxxx Pharmaceutica Products, L.P., a New Jersey limited partnership
having a principal place of business at 0000 Xxxxxxx-Xxxxxxxxxx Xxxx, Xxxxxxxxxx, Xxx Xxxxxx 00000
(hereinafter referred to as “JPPLP”) and Barrier Therapeutics, Inc., a Delaware corporation
having an address at 000 Xxxxxxx Xxxx Xxxx, Xxxxx 0000, Xxxxxxxxx, Xxx Xxxxxx 00000 (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 Xxxxxxx & Xxxxxxx 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:
“(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.
XXXXXXX PHARMACEUTICA PRODUCTS, L.P.
By:
|
/s/ XXXXX XXXXXX | |||
| Print Name: Xxxxx Xxxxxx | ||||
| Print Title: President | ||||
BARRIER THERAPEUTICS, INC.
By:
|
/s/ XX XXXXXXXX | |||
| Print Name: Xx Xxxxxxxx | ||||
| Print Title: Chief Commercial Officer | ||||
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