definiens: means all activities associated withcarrying out the analytical testing and release of the Product which are necessary for delivery of the Product for Developmentor sale in the Field in the Territory, but which are not necessary for delivery of the Product for Development or sale in theField in the U.S. Such activities shall include : transferring test methods, developing and validating new analytical testsrequired in the Territory, amending the release specifications to be in compliance with local Laws in the Territory, conductingthe release testing of the Product and final release of the Product ( including raw materials, intermediates, drug substance, drugproduct and sterile diluents ) . For clarity, preparation of reference standards to be used for Territory - Specific AnalyticalRelease Testing and Characterization includes analytical tests other than release testing ( e.g., mass spectrophotometry, isoelectrofocusing, N- and C - terminal sequencing, amino acid analysis, etc . ), which activities shall also be deemed Territory - Specific Analytical Release Testing and Characterization hereunder