Examples of Initial Development Plan and Budget in a sentence
Ablynx acknowledges that the exercise of its Commercially Reasonable Efforts as set forth in this Section 3.1.3 means the delivery by Ablynx to AbbVie of the (i) RA Complete Data Package by the date set forth in the Initial Development Plan and Budget, and (ii) 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.
Prior to completion of the Initial Development Activities, the JDC shall jointly develop the Development Plan for further Development (other than Development covered by the Initial Development Plan and Budget), which will occur after AbbVie proceeds with the In-Licensing, with respect to the Lead Compound for the Initial Indications.
Due to the lead-time for manufacturing, the initial Phase 3 clinical supply materials and associated manufacturing activities are set forth and included in the Initial Development Plan and Budget.
Either Party, directly or through its representatives on the JDC, may propose amendments to the Initial Development Plan and Budget from time to time.
Ablynx 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.
Further, Ablynx must obtain AbbVie’s prior written consent (not to be unreasonably withheld or delayed) for each Third Party Provider proposed by Ablynx that will provide services that would likely bridge the Initial Development Plan and Budget and the Development Plan (a period which is after AbbVie proceeds with the In-Licensing).
Following the successful completion by Ablynx of the Initial Development Activities in accordance with the Initial Development Plan and Budget and AbbVie proceeding with the In-Licensing, AbbVie 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.
After AbbVie proceeds with the In-Licensing, AbbVie shall have the sole right, at its expense, to Manufacture (or have Manufactured) and supply the Licensed Compound and Licensed Products for commercial sale in the Territory by AbbVie and its Affiliates and Sublicensees, except to the extent otherwise provided in the Initial Development Plan and Budget or any Development Plan.
Ablynx shall perform the Initial Development Activities, and shall do so in accordance with the Initial Development Plan and Budget by allocating sufficient time, effort, equipment, and skilled personnel to complete such Initial Development Activities.
After Xxxxxx proceeds with the In-Licensing, Xxxxxx shall have the sole right, at its expense, to Manufacture (or have Manufactured) and supply the Licensed Compound and Licensed Products for commercial sale in the Territory by Xxxxxx and its Affiliates and Sublicensees except to the extent otherwise provided in any Initial Development Plan and Budget or Development Plan and Budget.