Exhibit 10.42
FIRST AMENDMENT TO
DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT
This Amendment to
Development and Commercialization Agreement (this “
Amendment ”) is made and entered into this
Fourteenth day of December, 2004 (the “ Effective
Date ”), by and between Advancis Pharmaceutical
Corporation, a Delaware corporation (“ Advancis
”), and Par Pharmaceutical, Inc., a Delaware corporation
(“ Par ”).
WHEREAS, Advancis
and Par are parties to that certain Development and
Commercialization Agreement dated May 28, 2004 (the “
Development and Commercialization Agreement ”);
and
WHEREAS, Advancis
and Par wish to modify the Development and Commercialization
Agreement so that the development and commercialization of an
amoxicillin-only product for the pediatric population targeting
acute otitis media will be replaced by the development and
commercialization of an amoxicillin clavulanic acid product for
such indication, in accordance with the terms of this
Amendment.
NOW, THEREFORE, in
consideration of the mutual covenants and promises contained in
this Amendment and other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, Advancis
and Par agree as follows:
1.
Definitions; Format . All capitalized terms not otherwise
defined in this Amendment shall have the definitions ascribed to
such terms in the Development and Commercialization Agreement.
Where a textual passage is amended in part only, new language will
be shown double underlined , deleted language will be shown
in strikeout , and language that is unmodified will be shown
as an ellipsis (“...”). Double underlining, deleted
language and ellipses are for convenience only and are not part of
the Development and Commercialization Agreement, as
amended.
2.
Development Plan . Pursuant to Section 4.1 of the
Development and Commercialization Agreement, the Development Plan
had been agreed to by the Parties by letter dated June 2,
2004. The Parties agree to work together in good faith to mutually
agree in writing upon an amended and restated Development Plan
within one week of the Effective Date of this Amendment which will
reflect the modifications to the Development Program set forth in
this Amendment (the “ Amended and Restated Development
Plan ”). The Amended and Restated Development Plan
will be substantially similar to the most recent development plan
materials circulated by Advancis to Par as of the date of this
Amendment.
3.
Modification of Definition of Compound . Section 1.20,
the definition of “Compound” is amended to read as
follows:
“ Compound ” means,
individually and collectively, as applicable, the Amox-Only
Compound and the Amox-Clav Compound. the compound
amoxicillin, including all racemates, chelates, complexes,
enantiomers, diastereoisomers, salts, bases, esters, hydrates,
solvates, polymorphs, crystal forms, crystal habits,
-1-
prodrugs, isotopic or radiolabeled equivalents,
metabolites, or the like, thereof and all mixtures of any of the
foregoing.
4.
Addition of New Definition of Amox-Only Compound . A new
Section 1.20.1, the definition of “Amox-Only
Compound” is inserted to read as follows:
“ Amox-Only Compound ”
means the compound amoxicillin, including all racemates, chelates,
complexes, enantiomers, diastereoisomers, salts, bases, esters,
hydrates, solvates, polymorphs, crystal forms, crystal habits,
prodrugs, isotopic or radiolabeled equi
