definiens: shall mean that at any given time [COMPANY] shall be diligently engaging in one or 18 I - PHl1232732.23 more of the following Development activities for the lead Direct Thrombin Inhibitor or Licensed Product it has selected to Develop : [ formulation development, study / protocol design activity, awaiting protocol approval from the applicable institutional review board or FDA, patient recruitment, patient treatment, data analysis, report writing for any clinical trial, regulatory file ( s ) being drafted or pending, pricing or marketing approvals pending, manufacturing investment work, synthetic process development, drug synthesis, packaging development, manufacturing scale - up and validation, preclinical or in vitro characterization and go / no go decision awaited from a formal research and development committee within [COMPANY] to initiate any of the preceding activities . ] 4.5 Development Responsibility and Costs . Except in the case where 3DP Co­Develops Licensed Product for DVT in the United States as described in Section 4.7 herein, [COMPANY] shall have sole responsibility for, and shall bear the cost of conducting, Development with respect to Licensed Products and Direct Thrombin Inhibitors