definiens: means with respect to a given period, the followin g expenses to the extent specifically identifiable or reasonably allocable to the Optione d Product with respect to Commercialization or Medi cal Affairs Activities in the United States, or the man ufacture for use in such Commercialization activiti es, incurred by or on behalf of Sanofi or its Affiliates, and re corded as an expense by Sanofi or its Affiliate and incurred by Sanofi or any of its Affiliates or any of its Subli censees during the period commencing eighteen ( 18 ) months prior to anticipated launch, and any time thereafte r, in each case in accordance with Sanofi SOPs : 1 . COGS ; 2 . Distribution / Warehousing Costs ; 3 . Sales and Marketing Costs ; 4 . Regulatory Costs ; 5 . Marketing Study Costs ; 6 . Medical Affairs Costs ; and 7 . Third Party Payments