Estimated Development Costs Clause Samples
The Estimated Development Costs clause defines the projected financial outlay required for a development project, typically outlining anticipated expenses for labor, materials, and related services. This clause may specify how these estimates are calculated, the scope of costs included, and whether adjustments are permitted if actual costs differ from projections. Its core function is to provide transparency and set expectations regarding budgetary commitments, helping both parties plan effectively and avoid disputes over unforeseen expenses.
Estimated Development Costs. The budget set forth in the First Indication Development Plan (the “Development Budget”) shall set out the Third Party costs projected to be incurred by GW Pharma in the performance of its obligations under such Development Plan (including the cost to GW Pharma of relevant clinical trial insurance) other than the costs to GW Pharma of generating the CMC Data (“Development Costs”). The Development Budget shall estimate the Development Costs to be incurred by GW Pharma for each calendar quarter of each calendar year covered by such Development Budget. GW Pharma shall submit the first invoice in respect of GW Pharma’s estimated Development Costs from the Closing Date until the end of the first full calendar quarter after the Closing Date to Otsuka as soon as practicable following the Closing Date and this first invoice shall be payable within ten (10) days of its submission. Otsuka shall, upon receipt of GW Pharma’s invoices (other than for this first period) at least 30 days in advance, pay to GW Pharma GW Pharma’s estimated Development Costs for such calendar quarter by the 1st day of such calendar quarter. GW Pharma shall submit to Otsuka via the JDC a progress report and to Otsuka itself copies of invoices paid by GW during such calendar quarter to Third Parties for the performance of Development Plan activities within ten (10) days of the end of each such calendar quarter or within forty-eight (48) hours of their receipt from the Third Party, if later. Each progress report shall, without limitation, set forth in respect of clinical studies managed or conducted by GW Pharma under the Development Plan, the number of screened subjects, the number of enrolled subjects, the number of withdrawn or discontinued subjects, the number of completed subjects and such other information as may be reasonably requested by Otsuka. Pre-clinical studies conducted or managed by GW Pharma under the Development Plan and paid by Otsuka shall become a subject of the progress report due following the calendar quarter in which such pre-clinical study was completed. In respect of any such pre-clinical study, the progress report shall include the study report for such pre-clinical study and copies of all invoices paid by GW to Third Parties in respect of the performance of such pre-clinical study. The Parties shall discuss and agree any other information or data to be included in the format for the progress report. In the event the JDC or JCC (as applicable under Section 3.7) make ...
Estimated Development Costs. As of the Effective Date, estimated Development Costs (based on the Draft Development Plan) for the anticipated first (1st) three (3) Development Period Years are set forth on Exhibit E (collectively, the “Development Costs Estimate”). The Development Costs are subject to the “Notes and Assumptions” set forth in the Draft Development Plan and are expected to total amounts equal or less than the amounts presented in Exhibit E. The Development Plan includes a reasonable description of the anticipated Development Costs for the anticipated first (1st) three (3) Development Period Years. The Development Plan will include estimated FTE Costs and the Development Plan will list all FTEs (by title) with the associated FTE Rate and anticipated hours such FTE will dedicate to performing activities under the Development Plan in each applicable Development Period Year. The Annual FTE Costs based on the Draft Development Plan are expected to total to amounts equal or less than the amounts set forth on Exhibit I. If the JDC makes any changes to the Development Plan, or if any of the activities under the Development Plan are accelerated or delayed, the JDC will discuss in good faith whether Exhibit E and Exhibit I need to be amended by the Parties to reflect the then-current scope and timing of the activities set forth in the Development Plan. The Development Costs Estimate does not include any DRL Development Costs that may arise and that cannot reasonably be estimated by the Parties as of the Effective Date, including certain consultant costs and fees, intellectual property enforcement costs and as otherwise set forth in the “Notes and Assumptions” set forth in the Draft Development Plan (collectively, the “Additional Costs”). For clarity, the Development Cost Estimate only includes DRL’s technology transfer obligations under Section 4.3(c) and the cost to Journey, and does not include any other costs and expenses that may be incurred by or on behalf of Journey in connection with the technology transfer, which shall not be deemed “Development Costs”. Promptly upon becoming aware of anticipated Additional Costs, DRL will promptly present the anticipated Additional Costs to the JDC for review whenever such anticipated Additional Costs arise during the Development Period. Additional Costs will be subject to JDC approval. Journey shall be solely responsible for all Development Costs, including any approved Additional Costs, incurred under the terms and conditions of this Ag...
Estimated Development Costs. If ARCHEMIX exercises its Co-Development Option for an IL-23 Product as set forth in Sections 4.11.1 and 4.11.2, ELAN shall provide ARCHEMIX with ELAN’s revised non-binding, good faith estimate of all Development Costs and Commercialization Costs it expects to incur with respect to that Co-Developed Product (for the applicable Indications and formulations and, as to the Psoriatic Diseases Co-Development Option, Co-Development Territory(ies)) during the next four (4) Quarters on or before the first day of each full Quarter after the date of exercise.
Estimated Development Costs. In June of each Calendar Year ELAN and WARATAH shall provide each other with their respective non-binding, good faith estimates of all Development Costs and Commercialization Costs that each expects to incur with respect to the Product in the second half of the Calendar Year.
Estimated Development Costs. In ("deleted text") of each Calendar Year ELAN and WARATAH shall provide each other with their respective non-binding, good faith estimates of all Development Costs and Commercialization Costs that each expects to incur with respect to the Product in the second half of the Calendar Year.