definiens: means the expenses incurred by a Party that are consistent with a Development Plan and are specifically attributable or reasonably allocable to the Development of a Collaboration Product . Development Expenses shall include, but are not limited to, the following costs incurred for the Development of a Collaboration Product : the cost of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Collaboration Product directed to obtaining Regulatory Approval of a Collaboration Product ; the cost of Phase -3 - CONFIDENTIAL TREATMENT m - B Clinical Trials, and costs ( and related fees ) for preparing, submitting, reviewing or developing data or information for the purpose of submission to a Governmental Authority to obtain Regulatory Approval of a Collaboration Product ; and manufacturing process development and scale - up for Collaboration Products in bulk and finished form . Development Expenses shall exclude any internal costs ( e.g., staff or administrative ) incurred by a Party in connection with the Development of a Collaboration Product