definiens: shall mean all costs and expenses associated with obtaining Licenses, including without limitation . clinical 1rial costs, assay development and validation, development of seed stocks, production processes scale - up, formulation development, production of pre - licensing serials, conduct of field safety trials, application fees and other costs and expenses reasonably incidents thereto . As between . the parties, Registration Costs shall include labor and service charges at [COMPANY] 's standard hourly rates, as amended from time to time, direct cost of materials, and out - of - pocket and third - party expenditures . ' 13.]5 shall mean, as the context may require, either one or both of the following, which have been, mutually agreed upon by the parties : ( i ) vendor - certified appropriate quantitative and qualitative particulars for all raw materials inclucling active and non - active exc;pients that are used to prepare all components represented in and by flnal Products, and ( ii ) a : filed and approved USDA Outline of Production describing in detail the manufacturing process applicable for each Product and the testing and release criteria applicable to each Product