definiens: shall mean ( i ) all out - of - pocket expenses incurred by NovaDel to perform the agreed to development activities including, without limitation, expenses for contract research organizations, medical writing, statistical analysis, clinical trial investigative sites, clinical trial investigator grants and patient and/or subject costs, contract manufacturers, clinical trial insurance, and third party consultants for regulatory, chemistry manufacturing and control, and ( ii ) NovaDel 's reasonable and verifiable internal research and development staff costs of NovaDel employees working on such development activities allocated to the development of Licensed Product based on the time spent by such staff on such development activities as compared to other activities . In no event shall NovaDel Development Expenses include the costs of Licensed Product supplied to BioAliiance and paid for by BioAliiance, which shall be addressed by the supply agreement between the parties . For the avoidance of doubt, any Licensed Product required for use in connection with any agreed development activities performed by NovaDel will be purchased by BioAliiance under the terms of the supply agreement between the parties, and in the event that NovaDel needs any supply of active pharmaceutical ingredients, inactive ingredients, raw materials, placebos or comparators ( excluding Licensed Product or any materials used in manufacturing Licensed Product ) to conduct any development activity, BioAliiance shall be responsible, at its cost and expense, to provide any such materials to NovaDel