EXHIBIT 10.7
AGREEMENT REGARDING REGULATORY RESPONSIBILITIES
This AGREEMENT REGARDING
REGULATORY RESPONSIBILITIES (this “ Agreement
”), dated as of November 7, 2007, is entered into by and
between MiddleBrook Pharmaceuticals, Inc ., a Delaware
corporation (“ MiddleBrook ”), and Lex
Pharmaceuticals, Inc ., a Delaware corporation (“
Lex ”).
WHEREAS , MiddleBrook and Lex
have entered into an Asset Purchase Agreement, dated as of the date
of this Agreement, (the “ Asset Purchase Agreement
”) which, among other things, provides for the sale from
MiddleBrook to Lex of certain New Drug Applications (“
NDAs ”);
WHEREAS , pursuant to the
Asset Purchase Agreement, and subject to conditions set forth
therein, Lex may purchase a Notice of Claimed Investigational
Exemption for a New Drug, number 73,767 (“ IND
”) submitted by MiddleBrook to the United States Food and
Drug Administration (“ FDA ”);
WHEREAS, pursuant to the
terms of a Registration and Trademark License Agreement, dated as
of the date hereof, between MiddleBrook and Lex, MiddleBrook will
receive an exclusive license under the NDAs and, if purchased, the
IND; and
WHEREAS , MiddleBrook shall
assume all regulator
