definiens: means the actual costs, including [ * * ], properly incurred by a Party in connection with a Development Program ( to the extent specifically p rovided for in any development budget or any approv ed cost - overruns ) ( excluding any [ * * ] and [ * * ] required to be paid to any [ * * ] in connection with [ * * ] for, [ * * ] and [ * * ] any [ * * ] ), as Page 11 of 77 37155043.2 [ * * ] = CERTAIN CONFIDENTIAL INFORMATION OMITTED approved from time to time by the Joint Development Committee ( acting reasonably ) and specifically inc ludes the following to the extent so approved : a. reasonable & direct [ * * ] ( [ * * ] ) incurred by a Party properly allocable to the development activities d irectly related to the Development Program, including the costs associated with any required or approved [ * * ] or [ * * ] related to the Products such as [ * * ] or [ * * ] but excluding however [ * * ] and [ * * ] for [ * * ] ; b. amounts properly billed to a Party by a Third Party with respect to assistance rendered by such Third Party in connection with the Development Program ; c. amounts paid or accrued by any Party for the [ * * ], by [ * * ], [ * * ], [ * * ] or otherwise, of [ * * ] relating to and properly allocable to the Development Program ( which, for th e avoidance of doubt, shall constitute [ * * ] - unles s the same is [ * * ] - and the Parties shall have regard to clau se [ * * ] in this respect ) ; d. provided such costs are pre - approved by the Joint D evelopment Committee, the cost to a Party of [ * * ] a nd / or [ * * ] and [ * * ] ( excluding [ * * ] of the relevant Party or Affil iate thereof ) who will be [ * * ] in a Development Pro gram but only for the actual duration of each [ * * ] therein a nd at a [ * * ] or [ * * ] to such [ * * ] to such Developme nt Program which is pre - agreed in advance, provided further th at : 1 . the Party does not have the relevant [ * * ] or [ * * ] f rom within its own Development Program [ * * ] ; 2 . the aforesaid costs of such [ * * ] will be [ * * ] than the cost of [ * * ] the [ * * ] to be [ * * ] by a [ * * ] ; 3 . in no circumstances will any [ * * ] or [ * * ] and [ * * ] relating to [ * * ] of such [ * * ] constitute Shared Dev elopment Costs ; 4 . the parties shall use their commercially reasonable efforts to ensure that the Joint Development Commi ttee agrees a system for effectively monitoring [ * * ] by relevant [ * * ] on the Development Program