definiens: means the grant of all necessary regulatory and governmental approvals by a Regulatory Authority or other governmental body required to market and sell the Product in any country of the Territory but excluding any Pricing Approval ; Milestone Event means a Third Party to whom flynn Pharma has granted rights as a sub - distributor or sub - licensee in respect of the Products in the countries of the Territory other than the United Kingdom and Republic of Ireland in accordance with the terms hereunder ; means the plan for the marketing, distribution and sale of the Product in the Territory submitted to the Commercialisation Committee in accordance with clause 4 : means any period of twelve consecutive months ; means the UK Medicines and Healthcare Products Regulatory Agency or any successor thereto ; means an event identified in clause 6 which triggers a one - off Milestone Payment ; means each one - off payment by Flynn Pharma to Pacira identified in clause 6 which is by a Milestone means total gross sales of Product invoiced by Flynn Pharma its AfJiiiates and : \;1arketing Partners to Third Parties . less the following amounts actually deducted or allowed : ( i ) transport freight and insurance costs ( including for cross border movement of bulk shipments and local distribution within any country of the Territory ) ; ( ii ) sales and excise taxes and duties : 5 ( i ii ) normal and customary trade, quantity and and rebates : and discounts ( iv ) amounts repaid or credited for properly rejected, returned or rccalled goods ; means any improvement to the Pacini Patents and Pacini Know­How relating to the Product and developed by Pacira or Flynn Pharma or their respective Affiliates during the Term . Pacira Improvements shall constitute part of Pacira IP subject to Pacira ' s third - party agreements if any ; means the Pacira Know - How . Pacira Patents and Pacira Improvements ; means all information . procedures, instructions, techniques, elata, technical information . knmvledge and experience ( including