Initial Development Plan and Budget definition

Initial Development Plan and Budget means the initial Development Plan and Budget concerning the Development of Oncolym as set forth in more detail on Exhibit B hereto.

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Initial Development Plan and Budget means a development plan setting forth in reasonable detail specific Clinical Studies and the Initial Development Activities (and associated timelines) to be performed with respect to the Licensed Compound or Licensed Product and the related budget as set forth in Schedule 1.98, as the same may be amended from time to time in accordance with the terms hereof.

Initial Development Plan and Budget means the Development Plan and Budget covering the Initial Development Activities attached as Schedule 1.97, as the same may be amended from time to time in accordance with the terms hereof.

Examples of Initial Development Plan and Budget in a sentence

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.
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.
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 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 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.
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).
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.
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.
Either Party, directly or through its representatives on the JDC, may propose amendments to the Initial Development Plan and Budget from time to time.
Either Party, directly or through its representatives on the JDC, may propose amendments to the Initial Development Plan and Budget from time to time as appropriate, including in light of changed circumstances.

More Definitions of Initial Development Plan and Budget

Initial Development Plan and Budget means the initial Development Plan and Budget concerning the Development of the Product set out in Schedule Ito this Agreement.

Initial Development Plan and Budget means the initial Development ----------------------------------- Plan and Budget concerning the Development of Lisofylline for Development Indications during the period commencing with the Effective Date and ending on (i) in the case of the BMT Indication December 31, 1998 and (ii) in the case of the AML Indication, June 30, 1997, which Initial Development Plan and Development Budget has been agreed to by the Parties and is attached to a separate letter exchanged between the Parties concurrently herewith.

Initial Development Plan and Budget has the meaning set forth in Section 3.2.1.

Initial Development Plan and Budget means the initial Development Plan ------------------------------------- and Budget concerning the Development of an Eligible Compound or a Collaboration Compound for an Indication that is not, at the time the plan is prepared and agreed to as provided in Article V, an extant Development

Initial Development Plan and Budget means the Development Plan and Budget to be exchanged by the Parties as soon as reasonably possible after the Effective Date, in accordance with Section 3.2.

Initial Development Plan and Budget means a Development Plan and Budget to be submitted to the JSC for approval, pursuant to Section 2.4, within 10 days after the Effective Date.