definiens: means either ( a ) any corticoid product or formulation ( other than a Product, includingan Improvement ), whether alone or in combination for use in the treatment ofinflammatory diseases ; or ( b ) any product or formulation containing prednisone(other than a Product, including an Improvement ), whether alone or in combinationused for the treatment of diseases other than inflammatory diseases, that is developedor acquired by the Principal or its Associates or to which the Principal or itsAssociates has or is granted a license ; * * * Confidential Treatment Requested6 means the pharmacovigilance agreement to be entered into between the parties withinninety ( 90 ) days of the signing of this Agreement ; means both pricing and ( where approval is required for reimbursement ) reimbursementapproval as applied for by the Distributor and/ or its Associates in any country of theTerritory ; means any and all Intellectual Property related to the Product that is Controlled by thePrincipal as of the Commencement Date or during the Term including ( withoutlimitation ) the Intellectual Property licensed from SkyePharma plc and/or Jagotec AGregarding GeoClock Technology and its use with corticosteroids, the patent filed bySkyePharma plc consisting of [ … * * * … ] ( the ), the patent filed by the Principal consisting of [ … * * * … ] ( the ) ( and any patent applications, divisional patent applications, continuation applications, continuation in part applications, patents, supplementaryprotection certificates and extensions derived from or granted in relation to suchPrincipal Patent Applications ) insofar as they relate to corticosteroids, and any know - how Controlled by the Principal relating to the Product including pharmacokineticand clinical data, technical information, manufacturing formulae and methods andfurther techniques and designs of a confidential nature ; means modified release formulation of prednisone 1 mg, 2 mg, 5 mg and includingImprovements ; * * * Confidential Treatment Requested7 means a concept for a New Product under development or acquired or licensed by thePrincipal or its Associates in respect of which either in vitro laboratory data, in vivopharmacokinetic or clinical data or other appropriate test reasonably confirm that suchconcepts is feasible ; means any competent regulatory authority or other governmental body responsible forgranting a Marketing Authorisation or Pricing Approval in the relevant country of theTerritory ; means excluding all others except the Principal or a licensee of the Principal ; means the manufacturing and supply agreement entered into between the Principal andMundipharma Medical Company signed on the same date as this Agreement ; means the technical agreement to be entered into between the Principal and theDistributor or one of its Associates within ninety ( 90 ) days of the signing of thisAgreement ; means the countries listed in Schedule 1 ; means the period of time specified by Clause 19.1 ; means any person or entity other than the Principal or the Distributor or an Associateof either of them ; means the trademark Lodotra ™ that is Controlled by the Principal ; 81.2Any reference in this Agreement to or cognate expressions includes a reference to facsimile transmission