Regulatory Diligence. [[Party:Organization]] shall use Commercially Reasonable Efforts in undertaking the Development activities (including Initial Development Activities) for the initial Licensed Product containing or comprising the Lead Compound for the Initial Indications in those countries in the Territory set forth in the Initial Development Plan and Budget. [[Party:Organization]] acknowledges that the exercise of its Commercially Reasonable Efforts as set forth in this Section 3.1.3 means the delivery by [[Party:Organization]] to [[Organization A:Organization]] of the # RA Complete Data Package by the date set forth in the Initial Development Plan and Budget, and # SLE Complete Data Package by the date set forth in the Initial Development Plan and Budget, in each case, unless otherwise mutually agreed to by the Parties.

Diligence. Following the successful completion by [[Party:Organization]] of the Initial Development Activities in accordance with the Initial Development Plan and Budget and [[Organization A:Organization]] proceeding with the In-Licensing, [[Organization A:Organization]] shall use Commercially Reasonable Efforts to obtain all Regulatory Approvals for the initial Licensed Product containing or comprising the Lead Compound for the Initial Indications in accordance with the applicable Development Plan.