BAFO Submission definition

BAFO Submission means a selected Qualifying Bidder's response to the BAFO Document;
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BAFO Submission means a selected Qualifying Bidder's response to the BAFO Documentation.
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BAFO Submission means the documents entitled Merseyrail Electrics BAFO Submission submitted to DLA Solicitors (as agents for the Awarding Authority and the SRA) by the Bidding Consortium, on behalf of the Concessionaire and dated 24 January 2003.
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Examples of BAFO Submission in a sentence

  • Bidder Group Two or more persons acting together as a consortium for the purposes of any PQ, EPQ, QTT, ITT or BAFO Submission to Ofgem in accordance with the Tender Regulations.

  • Best and Final Offers (BAFOs) shall be organized and provided per the instructions of Section 3.3, Final Bids, except that all changes shall be marked with tracked changes, and shall include an Executive Summary of changes, with a corresponding statement, as described in Section 4.3.3, BAFO Submission.

  • BAFO Submission A selected Qualifying Bidder’s response to the BAFO Document.

  • The Referee will render his or her decision in writing, with detailed reasons, and shall provide a copy of the decision to each Party within 5 Business Days of the BAFO Submission Date or such later date as the Parties may agree in writing (the “Referee Review Period”).

  • The Referee will render their decision in writing, with detailed reasons, and shall provide a copy of the decision to each Party within 5 Business Days of the BAFO Submission Date or such later date as the Parties may agree in writing (the “Referee Review Period”).

  • Please refer to the BAFO Submission Instructions document provided as part of this Addendum.A137 c.

  • Bidder Group Two or more persons acting together as a consortium for the purposes of any PQ, QTT, ITT or BAFO Submission to Ofgem in accordance with the Tender Regulations.

  • Council officers and their professional team are now engaged in a due diligence exercise to understand the commercial assumptions underpinning the model and to compare it with the July 2007 BAFO Submission.


More Definitions of BAFO Submission

BAFO Submission means the Tender.
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Related to BAFO Submission

  • 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 any pricing or reimbursement approvals, as applicable, 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.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • 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.

  • Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the Funder. The form, content and scheduling of the Planning Submission will be identified by the Funder;

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

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

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

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with a Regulatory Authority in a country other than the United States to commence a clinical trial of pharmaceutical product.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • Electronic Submission means a successful submittal of Offeror’s proposal.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Bid Submission Date means the last date by which the City will accept Bids for an Invitation For Bid.

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Development Report means a written account of Licensee’s progress under the Development Plan having at least the information specified on Appendix B to this Agreement, and shall be sent to the address specified on Appendix B.

  • 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.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • 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.

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is: