Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.
Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.
Electronic Submission means a successful submittal of Offeror’s proposal.
Final Approval Hearing means the hearing before the Court where the Parties will request the Final Judgment to be entered by the Court approving the Settlement Agreement, the Fee Award, and the incentive award to the Class Representative.
Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.
Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.
Responding state means a state in which a petition or comparable pleading for support or to determine parentage of a child is filed or to which a petition or comparable pleading is forwarded for filing from another state or a foreign country.
Final Fairness Hearing means the hearing in the Action for the Court to consider final approval of this Settlement and the entry of Judgment.
Non-Acceptance of Proposal means another proposal was deemed more advantageous to the University or that all proposals were rejected.
Adjudicatory hearing means a hearing to determine:
Sending state means the state from which a child of a military family is sent, brought, or caused to be sent or brought.
Step therapy protocol means a protocol or program that establishes the specific
Locational Deliverability Area Reliability Requirement means the projected internal capacity in the Locational Deliverability Area plus the Capacity Emergency Transfer Objective for the Delivery Year, as determined by the Office of the Interconnection in connection with preparation of the Regional Transmission Expansion Plan, less the minimum internal resources required for all FRR Entities in such Locational Deliverability Area.
Notice of Hearing means a notice containing the information set out in Schedule VIII;
Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).
Bid Submission Date means the last date by which the City will accept Bids for an Invitation For Bid.
Expedited review means an examination, in accordance with
Locational Deliverability Area or “LDA” shall mean a geographic area within the PJM Region that has limited transmission capability to import capacity to satisfy such area’s reliability requirement, as determined by the Office of the Interconnection in connection with preparation of the Regional Transmission Expansion Plan, and as specified in Reliability Assurance Agreement, Schedule 10.1.
Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the LHIN. The form, content and scheduling of the Planning Submission will be identified by the LHIN;
Final Decision means a final action of the commission determining the legal rights, duties, or privileges of any person. “Final decision” does not include preliminary, procedural, or intermediate actions by the commission, actions regulating the internal administration of the commission, or actions of the commission to enter into or refrain from entering into contracts or agreements with vendors to provide goods or services to the commission.
Records Review means any assessment the Province conducts pursuant to section A.7.4 (Records Review).
Substantiated report means a report of sexual conduct that TSPC or ODE determines is founded.
Initiating state means a state in which a proceeding pursuant to this or a substantially similar reciprocal law is commenced.
Preponderance of evidence means evidence which is of greater weight or more convincing than the evidence which is offered in opposition to it.
Benchmarking Report means the report produced by the Supplier following the Benchmark Review and as further described in this Framework Schedule 7;
Protocol means, in respect of any category of object and associated rights to which this Convention applies, the Protocol in respect of that category of object and associated rights;