Work Plan; Budget Sample Clauses

Work Plan; Budget. (a) The Device Development Agreement, to be entered into by the Parties subject to Section 4.4, shall contain a work plan mutually agreed upon by the Parties to govern all activities to be conducted by the Parties leading up to initiation of Technology Transfer and through completion of Technology Transfer (the “Work Plan”), including agreed upon objectives, target timelines and a budget of estimated FTE Costs and Out-of-Pocket Costs (each as defined below) for the work needed to be done, supply forecast, pre-clinical and clinical development activities anticipated to be conducted by Novo Nordisk, and planned tasks and resource allocations (including establishing a joint core project team) by each Party with the goal of conducting the Licensed Product scale up and other mutually-agreed Technology Transfer activities until completion of Technology Transfer. (b) Subject to a budget approved, in writing, by both Parties, Novo Nordisk will pay ▇▇▇▇▇▇ for all of ▇▇▇▇▇▇’s out of pocket costs and expenses (“Out-of-Pocket Costs”) and internal costs for personnel at the FTE rate set forth below (“FTE Costs”), incurred after the Effective Date associated with device development, formulation, scale up, manufacture, supply and Technology CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. Page 18 of 52 Transfer activities under this Agreement or the Device Development Agreement until completion of the Technology Transfer. Zosano shall conduct development and transfer activities not covered under the Work Plan (or after the completion of Technology Transfer) reasonably requested by Novo Nordisk, to the extent that the conduct of such activities does not conflict with ▇▇▇▇▇▇’s internal operations and provided that Novo Nordisk reimburses Zosano for ▇▇▇▇▇▇’s FTE Costs and Out-of-Pocket Costs associated with the conduct of such activities, including technical support, manufacturing support, regulatory support and support of scale-up (and, for purposes of clarity, any reference to “at Novo Nordisk’s cost” in this Agreement shall mean ▇▇▇▇▇▇’s FTE Costs and Out-of-Pocket Costs). The initial FTE rate shall be at [**] (to be adjusted by ▇▇▇▇▇▇ on an annual basis based on changes in the Consumer Price Index (“CPI”), as quoted by the U.S. Department of Labor, Bureau of Labor Statistics, where the index as of January 1, 2014 shall be 100.) The FTE rate will not be adjusted until January 1, 2015....