definiens: and have the equivalent meaning ; means the registration(s ) of a Prod uct in the Territory as granted by the applicable Regulatory Authority ; means [ * * * * * ] alone for monotherapy, and not in combination with any other active ingredient ; means any patents and patent applications listed in Schedule 3, as may be supplemented from time - to - time by patents and pa tent applications filed by [COMPANY] in the Territory after the Effec tive Date relating to the [COMPANY] Technology and/or Formulation(s ) ; means any physical materials, including formulated Tiotropium or [ * * * * * ], set out in Part 1 of Schedule 2 ; means the Study Plan and, if applicable, the Develo pment, Regulatory and Commercialisation Plan ; means any product combining a Device with a Formulation ; ` means any data, reports or other documentation, inc luding the data package for PUR0200, in [COMPANY] ’s possession or u nder its control as at the Effective Date, as set out in Part 2 of Sche dul e 2 ; 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