definiens: means ( a ) with respect to the acute peripheral arterial occlusion and catheter occlusion indications, those Clinical Trials relating to Licensed Product sponsored by [COMPANY] that are i1 progress but not complete as of the Effective Date, including HA-004, HA-005, HA-006, HA-007, and HA-008 and ( b ) with respect to stroke, deep vein thrombosi s, or any other indications approved by the JSC, those Clinical Trials recommended by the IDC and approved by the JSC that are part of an integrated clinical development program whose primary goal is to generate data that the Parties anticipate at the time of trial design to be required to obtain Regulatory Approval of Licensed Product in the United States, the Major Countries, Canada and Japan . also includes such CMC activities, manufacturing process development and manufacture of clinical supplies of Licensed Product as are approved by the JSc . Global Development Programs may be conducted entirely or partially within the United States, or completely within the [COMPANY] Territory . excludes pricing studies and studies conducted for formulary approval