definiens: means : ( a ) any and all Intellectual Property owned or c ontrolled by [COMPANY] or its Affiliates at the Effective Date relating to the Pu lmatrix Technology and/or Formulation(s ), including the Patents and su ch rights in the [COMPANY] Data ; and ( b ) any improvements or developments thereto dev eloped independently of this Agreement ; and ( c ) any improvements or developments thereto cre ated or developed by or on behalf of [COMPANY] during the course of this Agre ement except to the extent such improvements or developments constitute [COMPANY] IP ; means [COMPANY] ’s proprietary iSPERSE ™ technology ; means a formulation of tiotropium applying the Pulm atrix Technology ; means any regulatory authority or competent body in any jurisdiction as relevant to the Formulation, Product or Study Produ ct and/or the Manufacture, approval, registration and sale thereo f, including the FDA ; shall have the meaning set out in Clause 6.3 ; means the Physical Material ’s specifications as set out in the Study P lan ; shall have the meaning set out in Clause 7.1 ; means the work plan of activities, fees and timelin es as detailed in Schedule 1 attached to this Agreement, which at the Effective Date is the Parties ’ best estimate of the work required to be undertaken to d evelop the Study Product ; means PUR0200 in a Device ; means a Third Party that may participate in the dev elopment and/or Manufacturing and/or the commercialisation of a Pro duct on behalf of [COMPANY] through a sub -licence agreement with [COMPANY] or its Affiliates ; shall have the meaning set out in Clause 2.1 ; means the United States of America, its territories and possessions ; THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURIT IES AND EXCHANGE COMMISSION ( THE ) PURSUANT TO RULE 24B- 2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, GRANTING CONFIDEN TIAL TREATMENT TO SELECTED PORTIONS . ACCORDINGLY, THE CONFIDENTIAL PO RTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPA RATELY WITH THE COMMISSION . OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH