Initial Submission definition

Initial Submission has the meaning given in Section 2.5(c).
Sample 1
Initial Submission shall have the meaning ascribed thereto in Section 6.6.
Sample 1
Initial Submission has the meaning set forth in Section 3.5(f)(i).
Sample 1

Examples of Initial Submission in a sentence

  • Charter School Average Daily Membership (CSADM) Projections for FY 2021-2022Phase I Due January 22, 2021 - All Charter, Regional, and UNC Lab Schools with current year enrollment are required to report between January 11 – 22, 2021.ALL charter school, regional school and lab school Executive Directors are required to submit the CSADM, Phase I - ADM Projection Initial Submission for School Year 2021-2022.

  • The Sponsors may, in their sole discretion, amend or supplement the RFP Documents prior to the Initial Submission Deadline.

  • Phase 1 Proposal Documents received after the Initial Submission Deadline and Phase 2 Proposal Documents received after the Final Submission Deadline, as documented by the time and date stamp, shall be returned unopened to the sender.

  • For the purposes of this RFP Process, the determination of whether either the Phase 1 Proposal Documents or the Phase 2 Proposal Documents were submitted before the Initial Submission Deadline or Final Submission Deadline, as applicable, shall be based on the time and date stamp the Proponent must ensure it receives at the address for submission set out in the RFP Data Sheet.

  • EXHIBIT B FIRM (ENTITY) CREDENTIALING REQUIREMENTS Minimum Qualification Requirement Initial Submission Renewal Thereafter Conflict of Interest Signed Vendor Conflict of Interest Form No. 501b Submitted with Firm’s Response to RFP June 1st annually, beginning in 2022 W-9 Signed IRS Form W-9 showing Legal Business Name, FEIN and remittance address.

  • In connection with the Initial Submission, neither of the parties may submit (and the arbitrator may not accept) any additional documentation (including affidavits).

  • Please refer to Section 2.2, Submittal Requirements for Initial Submission and Second Tier Additional Information, when Applicable, for the amount of copies to be submitted.

  • It is the sole responsibility of the Proponent to ensure that its Phase 1 Proposal Documents and Phase 2 Proposal Documents are received by Infrastructure Ontario prior to the Initial Submission Deadline or Final Submission Deadline, as applicable, and to ensure that the Proponent receives a date and time stamp receipt from Infrastructure Ontario confirming the timely delivery of each of the Phase 1 Proposal Documents and Phase 2 Proposal Documents.

  • The Sponsors may, in their sole discretion, refuse to accept a change in an Identified Proponent Party that occurs or is requested by the Proponent after the Initial Submission Deadline and may, in their sole discretion, disqualify the Proponent from continuing in the RFP Process.

  • The Sponsors may use the negotiations process to negotiate any aspect of the Negotiations Proponents’ Proposals or the Project Agreement Documents, or both, including, for clarity, any amendments to the Project Agreement Documents that are reasonably required to accommodate the Negotiations Proponents’ financing arrangements or impacts of a Relevant Change in Law arising after the Initial Submission Deadline.


More Definitions of Initial Submission

Initial Submission has the meaning given in Section 2.5 [Fast Track Referee Process] in Schedule 20 [Dispute Resolution Procedure].
Sample 1
Initial Submission has the meaning set forth in (S)10.2(a). ------------------
Sample 1
Initial Submission has the meaning set forth in §10.2(a).
Sample 1
Initial Submission. Not later than 2 working days after access is no longer required 12. SUBMISSION FREQUENCY: As required
Sample 1
Initial Submission. Not later than 10 working day following end of first period of performance
Sample 1

Related to Initial Submission

  • 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;

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

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

  • IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the equivalent agency in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • Clinical Trial means a Phase I Clinical Trial, Phase II Clinical Trial or Phase III Clinical Trial, or any post-approval human clinical trial, as applicable.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Final completion and acceptance means the stage in the progress of the work as determined by the Contracting Officer and confirmed in writing to the Contractor, at which all work required under the contract has been completed in a satisfactory manner, subject to the discovery of defects after final completion, and except for items specifically excluded in the notice of final acceptance.

  • Development Candidate means a Collaboration Compound designated by Biogen Idec as a Development Candidate in accordance with Section 2.6.

  • Feasibility Study means a comprehensive study of a deposit in which all geological, engineering, operating, economic and other relevant factors are considered in sufficient detail that it could reasonably serve as the basis for a final decision by a financial institution to finance the development of the deposit for mineral production;

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • Phase IV Clinical Trial means a Clinical Trial conducted after a Product achieves Regulatory Approval, carried out for purposes of conducting safety surveillance and ongoing technical support of the Product.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Additional SDU Study means a deliverability study that a Developer may elect to pursue as that term is defined in OATT Section 25 (OATT Attachment S). For purposes of Section 23.4.5 of this Attachment H, “Affiliated Entity” shall mean, with respect to a person or Entity:

  • Non-Acceptance of Proposal means another proposal was deemed more advantageous to the University or that all proposals were rejected.