definiens: shall mean on a Regulatory Jurisdiction per Regulatory Jurisdiction basis and pro - rated per month for each year during the five year period after Commercial Launch, with the exception of paragraphs ( ii ) and ( iii ) below which shall only be considered for the calculation of Excess ( as defmed in Section 6.2.5 ) in the first 12 months after Commercial Launch in a Regulatory Jurisdiction : ( i ) SB ' s fully absorbed standard cost of goods, formulation, bulk manufacturing, filling, packaging and storing of the Products ; and ( ii ) Costs related to regulatory approvals to the following extent : ( a ) from the moment of Commercial Launch in Major Markets and 12 months thereafter, all costs incurred by SB during the year preceding Commercial Launch ( including a reasonable overhead ) related to regulatory approvals up to and including PLAIELA in such Major Market ; ( b ) for the purpose of determining said costs under paragraph ( ii)(a ) above in Regulatory Jurisdictions other than Major Markets, the average weighted cost per unit of Product as this results from paragraph ( ii)(a ) for Major Markets, shall apply to number of doses sold in the Regulatory Jurisdiction other than Major Markets in the 12 months period after Commercial Launch in such Regulatory Jurisdiction ; and ( iii ) Prelaunch cost : as from Commercial Launch in a Regulatory Jurisdiction and 12 months thereafter, all prelaunch costs ( including a reasonable overhead ) incurred by SB during the year preceding Commercial Launch in such Regulatory Jurisdiction necessary for the marketing, distribution and selling of the Product in such Regulatory Jurisdiction ; and APH0005 ( iv ) Costs relating to marketing distributing and selling the Product in Major Markets as such costs result from the forecasted costs given under the Marketing Plan for such Major Market in such year . For the purpose of determining such costs under this paragraph ( iv ) for Regulatory Jurisdictions other than Major Markets, the average weighted percentage of such costs on Net Sales in Major Markets shall apply for said Regulatory Jurisdictions