Initial Development Activities definition

Initial Development Activities means those activities to be performed in furtherance of the following Clinical Trials: [***], each of which ((a) – (c)) is separately described in the TAK-385 Development Plan.

Initial Development Activities means the key development activities and related expenditures anticipated in the thirty (30) days following the Effective Date as set forth in Exhibit 1.53 (Initial Development Activities), attached hereto.

Initial Development Activities means the Development activities (as further set forth in the Initial Development Plan and Budget) to be performed by Galapagos in order to achieve the Phase 2B RA Success Criteria.

Examples of Initial Development Activities in a sentence

• Each Party shall perform or cause to be performed, any and all of its Development activities, including Initial Development Activities, in good scientific manner and in compliance with all Applicable Law.

• Notwithstanding anything to the contrary set forth herein, Licensee will complete all such Initial Development Activities and provide to Takeda all data, reports, and other Information generated in the performance thereof on or prior to [***].

• Licensee will be solely responsible for the conduct of all Initial Development Activities and all expenses, including Third Party expenses, related to such Initial Development Activities.

• The Parties acknowledge that during the thirty (30)-day period immediately following the Effective Date, Coherus will undertake the activities set forth in Exhibit 1.29 (Initial Development Activities), pursuant to which Coherus will incur the Reimbursable Costs included therein.

• Lilly shall own all Regulatory Approvals after the conclusion of the Initial Development Activities and be responsible for all decisions in connection therewith for Regulatory Approvals of Products in the Field and in the Territory; provided, that Nektar shall cooperate in these efforts as reasonably requested by Lilly.

More Definitions of Initial Development Activities

Initial Development Activities means the Party Development Activities set forth in the Initial Development Plan to be performed by Licensor (or, pursuant to Section 3.1.2 or 5.10.3, Licensee) in order to obtain Product Approval for the Initial Licensed Compound (or any Backup Compound pursued in its stead pursuant to Section 5.10) for the applicable Initial Indication in the Major Markets and in the United States.

Initial Development Activities means the development activities that the Parties intend to be primarily performed (subject to Section 4.4(a)) by Nektar in accordance with the initial Product Development Plan attached hereto as Schedule 4.1, including the performance of [***] and enabling activities to support additional stages of development.

Initial Development Activities means the Development activities to be performed by Ablynx (or, pursuant to Section 3.1.2, by AbbVie) in order for Ablynx to achieve the Phase 2A SLE Success Criteria and the Phase 2B RA Success Criteria as further set forth in the Initial Development Plan and Budget.

Initial Development Activities has the meaning set forth in Section 3.1.1.

Initial Development Activities means any and all Development activities set forth in the Initial Development Plan to be performed by Harpoon (or, pursuant to Section 3.1.2, AbbVie) in order to advance the Licensed Compound and Licensed Product to the point of readiness to commence [***] (or to proceed directly to pivotal clinical trials, if applicable) and ultimately support the filing of Drug Approval Applications and obtain Regulatory Approvals for a Licensed Product in the Field in the Territory.

Initial Development Activities has the meaning set forth in the Amplixa Global Development Outline as agreed as of the Execution Date.

Initial Development Activities shall have the meaning set forth in Section 2.1.2.