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
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compound amoxicillin, including all
racemates, chelates, complexes, enantiomers, diastereoisomers,
salts, bases, esters, hydrates, solvates, polymorphs, crystal
forms, crystal habits, 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 equivalents, metabolites, or the like, thereof and all
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