definiens: means, for each Clinical Development Candidate, a detailed plan that sets forth theresponsibilities of, and the activities to be conducted by, each of the Parties in advancing each such Clinical DevelopmentCandidate to Regulatory Approval for a Cardiovascular Indication ( including a detailed budget corresponding to each suchplan ) . Each such Clinical Development Plan shall include, without limitation, the following activities ( or their equivalents),to the extent applicable : ( a ) conducting pre - clinical research, pre - clinical development and other pre - clinical studies that are intended tosupport clinical development of a Clinical Development Candidate for a Cardiovascular Indication;- 3 -Table of Contents ( b ) preparation and filing of an IND for a Clinical Development Candidate for a Cardiovascular Indication ; ( c ) conducting clinical trials of such Clinical Development Candidate for a Cardiovascular Indication, includingclinical trials that are intended to support Regulatory Approvals for such Clinical Development Candidate for suchCardiovascular Indication ; and ( d ) preparation and filing of documentation, applications ( including, for example, an NDA / BLA ) and related activitiesto enable the Parties to seek Regulatory Approval for such Clinical Development Candidate for such CardiovascularIndication