definiens: means, with respect to a Product, all FTE Costs a nd out - of- pocket costs actually incurred by a Party to Third Parties ( collectively ) after the Effective Date in connection with the Development of such Product in accordance with the r elevant POC Plan or Therapeutic Development Plan and POC Budget or Therapeutic Development Plan Budget, as determined from the books and records of the applicable Party and/or its Affiliat es maintained in accordance with the Accounting Standards and each P arty ’s policies and practices as such may be modifi ed from time to time . For clarity, Development Costs shall include all filing fees and expenses associated with regulatory submissions to a Governmental Authority for the Products . In the eve nt that the Pa rties mutually agree in a POC Plan or Therapeutic Development Plan to conduct activities separately or in advance with respect to products incorporating the [COMPANY] Core Technology or Selecta Core Technology, but not both together, in connection with, or in preparation for the Developm ent of a Product, the FTE Costs and out - of- pocket costs associated with such activities shall neverth eless be included in Development Costs