definiens: shall mean any Product sold for administration by injection, except for thoseProducts sold for administration directly into a vein, such as for administration by intravenous injection andintravenous infusion . ” 1.2 The definition of Budget is amended as follows : shall mean the budget for the Development Plan as updated and approved at least annually by theDT and JSC, if applicable . ” 1.3 The definition of Commercialisation is amended as follows : ( including variations such as and the like ) shall mean theperformance of any and all activities directed to promoting, marketing, importing, exporting, distributing, selling or offering to sell ( including pre - marketing ), and post - marketing drug surveillance of the Product(including any Phase IV Clinical Trials and GHO Studies ) or, to the extent permitted under this Agreement, tohave any of those activities performed by a Third Party, but excludes Development and Manufactureactivities . ” 1.4 The last paragraph of the definition of Development Costs shall be amended as follows : “ but specifically excluding ( a ) Commercialisation Costs ( including but not limited to GHO Costs ), ( b ) FullyBurdened Manufacturing Costs ( other than those associated with the Manufacture of Clinical Supplies),(c ) Patent Costs except as otherwise indicated in Clause 10.9, and ( d ) expenses relating to filing andmaintenance of Product Tradenames or [COMPANY] Trademark registrations . ” 1.5 The definition of Development Plan is amended as follows : shall mean the plan for the Development of the Product for the Oncology Indication asupdated and approved at least annually by the DT and JSC, if applicable . ” 1.6 The definition of FTE Cost is amended as follows : shall mean, for any period, ( i ) the percentage of time during full time employment each full timeemployee is involved in the Development or Manufacture of the Product in accordance with this Agreement, multiplied by ( ii ) the number of employees involved in such activity for such percentage of time, multiplied by(iii ) an amount equal to [ * * * ] pounds sterling [ * * * ] per Calendar Year ( or pro rata amount thereof ) for each FTEinvolved in the Development or Manufacture of the Product in accordance with this Agreement