Estimated Program Approval Date definition

Estimated Program Approval Date means, for each Project or Sub-Program thereof for which Program Approval has not been achieved, the estimated date for Program Approval as set forth on the page titled “Project Business Plan – Timing” under the heading “Project Business Plan – Timing” and column “PA” of the Project Business Plan.
Sample 1

Related to Estimated Program Approval Date

  • Final Approval Date means the date on which the Court enters its Order and Judgment approving the Settlement.

  • Approval Date means the date on which the Plan is approved by the Company’s stockholders.

  • Preliminary Approval Date means the date on which the Court enters the Preliminary Approval Order.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Post-Closing Straddle Period means the portion of a Straddle Period beginning the day after the Closing Date.

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

  • Target Completion Date has the meaning given such term in Section 3.3(b).

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Pre-Closing Straddle Period means the portion of the Straddle Period ending on the Closing Date.

  • Non-Approval Event means, in respect of the Benchmark:

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Estimated Closing Statement has the meaning set forth in Section 2.4(a).

  • Disclosure Statement Approval Order means the Final Order approving, among other things, the adequacy of the Disclosure Statement pursuant to section 1125 of the Bankruptcy Code.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Development approval means any written authorization from a

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

  • Project Completion Date means the date on which the Completion Certificate is issued;

  • Estimated Closing Working Capital has the meaning set forth in Section 2.04(a)(ii).

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Estimated Transaction Expenses has the meaning set forth in Section 2.3(a).