Additional Development Costs definition

Additional Development Costs means those Out-of-Pocket Costs and FTE Costs incurred by the Proposing Party in performing the relevant Additional Development Activities, which costs shall be determined using the same manner of calculating Development Costs and Allowable Expenses as if such Additional Development Activities had been incorporated into the Development Plan.

Additional Development Costs means the charges for any Additional Development undertaken by the Supplier on either a time and materials basis or on an agreed fixed cost basis as more particularly detailed in the relevant notice.

Additional Development Costs has the meaning set forth in Section 6.5.2(b)(i).

Examples of Additional Development Costs in a sentence

• If, within [***] days of the Declining Party’s receipt of the Phase 3 Update, the Declining Party submits an Additional Development Opt-In Notice to the JPT and Proposing Party: (1) the Declining Party shall, subject the review rights set forth in to Section 8.6.1(b), pay to the Proposing Party an amount equal to [***] of the Additional Development Costs identified in the Phase 2 Update and Phase 3 Update and (2) the terms of Section 4.2.4(e)(iv) shall apply.

• In the event that the Declining Party does not submit the Additional Development Opt-In Notice in accordance with Section 4.2.4(e)(i) or (ii), and the Proposing Party receives Regulatory Approval in a Major Market country with respect to the Additional Development Activities, the Proposing Party shall promptly notify the Declining Party in writing of such Regulatory Approval and the Additional Development Costs incurred by the Proposing Party (the “Regulatory Approval Update”).

• Subject to the terms and conditions Customer may be charged with Additional Development Costs as stipulated in Order.

• Within [***] days after the date of the database lock for the first Phase II Trial related to the Additional Development Activities, the Proposing Party shall furnish to the JPT and the Declining Party, a written report of the results of such Clinical Study and the Additional Development Costs incurred by the Proposing Party (the “Phase 2 Update”).

• In the event that the Declining Party does not submit the Additional Development Opt-In Notice in accordance with Section 4.2.4(e)(i), then within [***] days after the date of the database lock for the first Phase III Trial related to the Additional Development Activities, the Proposing Party shall furnish to the JPT and the Declining Party, a written report of the results of such Clinical Study and the Additional Development Costs incurred by the Proposing Party (the “Phase 3 Update”).

More Definitions of Additional Development Costs

Additional Development Costs means: (i) all Development Costs incurred in conducting the NSCLC POC Trial Plan in excess of the Cap; (ii) all Development Costs associated with the Development of Ficlatuzumab under the Development Plan other than costs incurred in conducting the NSCLC POC Trial Plan; and (iii) Ficlatuzumab Cost of Goods for supply in excess of the Existing Supply of Ficlatuzumab. If Biodesix incurs Additional Development Costs with the approval of the JSC, such costs shall be reconciled with, and off-set from, as appropriate, the Additional Development Costs incurred by AVEO such that each Party bears 50% of the aggregate Additional Development Costs.

Additional Development Costs has the meaning set forth in Section 9.3.4(a).

Additional Development Costs means all Additional Essential Element Expansion Costs, Additional Label Expansion Costs, and Additional First Approval Costs.

Additional Development Costs means, after the Development Costs arising out of the approved Original ODP have been fully recovered, the capital expenditures incurred when carrying out the Additional Development Operation within the Contract Area.

Additional Development Costs means, with respect to an Additional Development Project, all Development Costs attributable to the Additional Development Activities with respect to such Additional Development Project.

Additional Development Costs means, with respect to a Discretionary Amendment under which Company elects not to fund any Development Costs in excess of the Budget Threshold pursuant to Section 2.2(c)(iii), Company’s applicable share of the Development Costs incurred by or on behalf of Regeneron under such Discretionary Amendment in excess of the Budget Threshold not to exceed [***********], from the Effective Date through completion of the Initial Development Plan.

Additional Development Costs means all reasonable third party direct costs incurred to conduct the Additional Development in accordance with the Development Plan. For example, if the parties incurred Additional Development Costs in the amount of US$[***], then each party would bear US$[***] and Pioneer would bear an additional US$[***]; and Pioneer will have the right to deduct the Additional Development Costs it bears in the amount of US$[***] (US$[***] + US$[***]) from the Price of the Product as described under Exhibit D.