definiens: or means, in respect of a Product, the [ * * * ], but excluding : ( A ) [ * * * ] ( B ) [ * * * ] ( C ) [ * * * ] means the period of time that, from the date of a Firm Order, [COMPANY] will require to : ( A ) supply the relevant Existing Clinical API, Existing Clinical Product or Existing Clinical Placebo ( including sufficient time to allow for ordering and d elivery of Materials ) ; or ( B ) Manufacture and supply to the Third Party responsible for undertaking analytical testing in respect of the applicable Product, the relevant New Clinical Product, New Clinical Placebo or New Clinical API ( including sufficient time to allow for ordering and delivery of Materials and Existing Clinical API ), in each case as specified in Part A of Schedule 1 or as otherwise notified in writing by [COMPANY] to the Purchaser from time to time . For the avoidance of doubt, Delivery in respect of New Clinical Product, New Clinical Placebo and/or New Clinical API shall not occur until ( i ) the Third Party responsible for undertaking analytical testing in respect of the applicable Product has conducted the relevant analytical tests and provided the results of those test to G SK and ( ii ) [COMPANY] has conducted a technical release of that Product on the basis of such results and in accordance with the Quality Agreement and, accordingly, the Lead Time does not identify the expected date of Delivery in respect of New Clinical Product, New Clinical Placebo and/or New Clinical API