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
Agencies may in- corporate the information required under 5 U.S.C. 602 and [former] 41 U.S.C. 402 into these agendas.(c) The Regulatory Plan.
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 Regulatory Plan and Unified Agenda do not create a legal obligation on agencies to adhere to schedules in this publication or to confine their regulatory activities to those regulations that appear within it.
No. -- The sequence number identifies the location of an entry in the printed edition of the Regulatory Plan and the Unified Agenda.
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 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 shall have the meaning set forth in Section 5.2.2. ---------------
Regulatory Plan shall have the meaning assigned to such term in Section 5.1(b) hereof.
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.