Regulatory Plan definition

Regulatory Plan has the meaning set forth in Section 3.2.

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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 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.

• SENOMYX shall solicit PEPSICO input to such Regulatory Plan during the regular Steering Committee process, but in the event of any disagreement between the parties SENOMYX shall have final decision making authority.

• Details shall be agreed upon between the Parties in the Regulatory Plan.

• Forest shall, directly or indirectly through its Affiliates or Sublicensees, use Commercially Reasonable Efforts to Develop and obtain Regulatory Approval for a Memantine-Donepezil FDC Product in the Field in the Territory in accordance with the Development Plan and the Regulatory Plan, including the conduct of the DM303 and DM304 studies.

• Each Party will report on Development activities, if any, undertaken by it in accordance with Development and Regulatory Plan in connection with meetings of the JSC, including by providing a reasonably detailed summary of all results, data, and material inventions, if any, obtained from such activities.

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 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 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;

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 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.