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 Regulatory Plan appears in part II in a daily edition of the Federal Register.

• An asterisk (*) indicates agencies that appear in The Regulatory Plan.

• 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.

• While companies may plan an exit strategy prior to bringing a product to late-stage clinical development (P2 and or P3) or to the market, the development and adherence to a logical, expeditious, and fully integrated regulatory plan is advisable to maximize value for any potential purchaser.Accordingly, the Regulatory Plan is an important part of the CPRIT application and an opportunity for the successful applicant to demonstrate proficiency and expertise.

• While companies may plan an exit strategy prior to bringing a product to late-stage development or to the market, the development and adherence to a logical, expeditious, and fully integrated regulatory plan are advisable to maximize value for any potential purchaser.Accordingly, the Regulatory Plan is an important part of the CPRIT application and an opportunity for the successful applicant to demonstrate proficiency and expertise.

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 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. 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 the plan containing regulatory services and support for regulatory submissions and supporting documentation for Production of Products attached as Exhibit 9, as amended, supplemented or restated from time to time by mutual written agreement of 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 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 a regulatory plan outlining the regulatory strategy for obtaining Marketing Authorisations for the Drug Product and split of regulatory responsibilities of the Parties with the aim of ensuring equitable and affordable access to the Product for people in the DNDi Territory and the Entasis Territory at the earliest possible date, as further described in Schedule 4 hereto and in Clause 5, as may be amended from time to time;