Initial Submission definition

Initial Submission has the meaning given in Section 2.5(c).
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

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.

  • 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.

  • 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.

  • 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.

  • 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 Section 3.5(f)(i).
Sample 1
Initial Submission shall have the meaning ascribed thereto in Section 6.6.
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

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, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 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).

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • 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, as applicable.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.

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

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • 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 Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • Development Candidate means a Compound that meets the Development Candidate Criteria for the initiation of a Development Program for the treatment of CF, and which is the subject of a notice from Vertex to CFFT that Vertex intends to commence formal pre-clinical development of the Compound in the Field pursuant to the provisions of Section 3.1 hereof.

  • Feasibility Study means the evaluation and analysis of the potential of a project, which aims at supporting the process of decision-making by objectively and rationally uncovering its strengths and weaknesses, opportunities and threats, as well as identifying the resources required to carry it through and ultimately its prospects for success;

  • 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 trial involving administration of a Compound to sufficient numbers of human patients with the goal of establishing that the Compound is safe and efficacious for its intended use, to define warnings, precautions and adverse reactions that are associated with the drug or label expansion of such Compound, and to be considered as a pivotal study for submission of an NDA.

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Phase II Study means a human clinical trial, for which the primary endpoints include a determination of dose ranges and/or a preliminary determination of efficacy in patients being studied as described in 21 C.F.R. § 312.21(b) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • 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:

  • Additional Indication means any indication other than the Initial Indication.