definiens: ProductProduct DataQuarterRegulatory AuthoritySupply means any pncmg and reimbursement approval required by a Regulatory Authority to enable of the Product in any country of the Territory follovving grant of the Marketing Authorisation in that country ; means the DepoFoamf:\l formulation of morphine sulphate for epidural administration presented in vials . appropriately packaged and labclled for sale to end users in such presentations and dosages as required in each country in the Territory and as are defined in the Supply Terms ; means all data . information or results in the performance of any clinical studies . non - clinical studies ( including pharmacological and toxicological studies ) or chemistry and analytical studies, market . customer and product utilisation studies and reports in respect of the Product conducted by or on behalf of either party whether before or after the Date ; means a three month period ending on the last day of March, June, September or December in any Calendar Year ; means any competent regulatory authority or other governmental body ( for example . but not by way of limitation the EMEA or MHRA ) responsible for granting a Marketing Authorisation or Pricing Approval in any country within the Territory ; means the terms and conditions for the supply of the Product by Pac ira to be negotiated by the parties pursuant to clause 5.10 ; means the term of this Agreement as sct out in clause 15 ; 7 ' means the countries listed in Schedule V : ' means any company, corporation, firm, individual or other entity but excluding a party to this Agreement or an Affiliate ; means those trade marks registered or applied for set out 111 Schedule II and such other trade marks as are agreed between the parties from time to time : means a vial containing the Product supplied to Flynn Pharma in presentations and dosages and other relevant terms set out in the Supply Terms ; means the period of twelve months commenCll1 g on the first Commercial Delivery of the Product in the Territory, and each consecutive period of twelve months thereafter during the Term