Regulatory Plan definition

Regulatory Plan has the meaning set forth in Section 3.2.

Regulatory Plan has the meaning set forth in Section 5.1(a).

Regulatory Plan means a plan regarding the timing and approach to preparing, submitting or reviewing Regulatory Materials and obtaining and maintaining Drug Approval.

Examples of Regulatory Plan in a sentence

• The RSB’s Regulatory Plan or Annual Return (as applicable) and interim reporting will contain such detail as the FRC reasonably requires for the FRC to fulfil its statutory oversight and reporting responsibilities.

• The RSB has submitted to the FRC key principles of its work plan in relation to this task by way of the RSB’s submission to the FRC of its Regulatory Plan in accordance with Appendix 5 or such other information as the FRC may reasonably request.

• Annual Regulatory Plan The Ministry may request that Tarion provide further information on the rationale, anticipated impacts, and timing of individual proposals as requested by the Ministry.

• This plan offers the functionality of the Regulatory Plan and adds support for engine and accelerometer data.

• The Signatories also have agreed that certain costs incurred subsequent to the test year, as well as related costs should be capitalized to the Regulatory Plan Capital Investment project to which they apply.

More Definitions of Regulatory Plan

Regulatory Plan means the comprehensive plan or plans and overall strategy, and any updates thereto, for preparing and filing any and all Regulatory Filings regarding Cell Therapy Products or Collaboration Products (in accordance with customary standards for a product of comparable market potential) and for communications with Regulatory Authorities, including all interactions with respect to such Regulatory Filings. The Regulatory Plan shall include, but not be limited to, a reasonably detailed description of the schedule of the work activities, responsibility for the work activities and an associated budget.

Regulatory Plan. Regulatory Plan means the regulatory strategy with respect to the Development of Memantine-Donepezil FDC Product as agreed to by the Parties in writing as of the Effective Date, as it may be modified from time to time in accordance with this Agreement. The Regulatory Plan as agreed as of the Effective Date is attached hereto as Schedule 1.80.

Regulatory Plan means document(s) containing regulatory services and support for the development and maintenance of regulatory submissions and supporting documentation to be performed by Baxter as mutually agreed upon by the Parties.

Regulatory Plan means the document(s) containing regulatory services and support for the development and maintenance of regulatory submissions and supporting documentation as set forth in Section 2.3.

Regulatory Plan shall have the meaning set forth in Section 5.2.2. ---------------

Regulatory Plan means a plan regarding the timing and approach to preparing, submitting or reviewing Regulatory Materials and obtaining and maintaining Drug Approval in the Licensed Territory.

Regulatory Plan means an Initial Regulatory Plan as updated as contemplated under Section 5.1.