definiens: means the expenses incurred by a Party that are c onsistent with a Development Plan and are specifically attributable or reasonably allocable to the Development of a Collaboration Product . Development Expenses shall i nclude, but are not limited to, the following costs incurred for the Development of a Collaboration Product : the cost of studies on the toxicological, pharmacokine tic, metabolic or clinical aspects of a Collaboration Pr oduct directed to obtaining Regulatory Approval of a Collaboration Product ; the cost of Phase - 3 - III - B Clinical Trials, and costs ( and related fees ) for preparing, submitting, reviewing or developing data or information for the purpose of submission to a Gove rnmental Authority to obtain Regulatory Approval of a Collaboration Product ; and manufacturing process de velopment and scale - up for Collaboration Products i n bulk and finished form . Development Expenses shall exclu de any [ * ] incurred by a Party in connection with t he Development of a Collaboration Product