Successful Completion means that in the reasonable opinion of the Customer, Deliverables completed by the Supplier are fit for purpose, completed on time and otherwise meet all the criteria defined under this Contract;
Successful Vendor means the organization or person with whom the order is placed or who is contracted to execute the work as detailed in the bid.
Successful Applicant means an “employee applicant” or “applicant” who has been offered employment within this Bargaining Unit by the Employer.
Successful Bid means the Bid of the Successful Bidder for acquisition of the Corporate Debtor on Going Concern basis as declared by the Liquidator as per this Process Memorandum;
Successful Proposer means any Proposer selected by the University to receive an Award as a result of this RFP and to enter into a Contract to provide the University with the products or services sought by this RFP.
Successful Syndication shall have the meaning given to such term in the Fee Letter.
Successful Proponent means a Proponent who the City may award the agreement to, as a result of this RFP document.
Successful Bidder” or “Successful E-Auction Process Participant means, the Qualified Bidder whose bid is approved and who is declared successful by the Liquidator at the end of the determined auction phase.C. INTRODUCTION
Successful Remarketing means, as applicable, a Successful Optional Remarketing or a Successful Final Remarketing.
Successful Bidder As defined in Section 7.01(c).
Development Milestone Event has the meaning set forth in Section 7.2.1.
Phase III Trial means a Clinical Trial of an investigational product in subjects that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to generate data and results that can be submitted to obtain Regulatory Approval as described in 21 C.F.R. 312.21(c), or a comparable Clinical Trial prescribed by the relevant Regulatory Authority in a country other than the United States.
Project Milestone means the project milestone set forth in Schedule-J;
Milestone Date means the date set against the relevant Milestone in the Implementation Plan;
Successful Bidder(s) means the bidder(s) to whom work in this tender is awarded.
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.
Development Milestone is defined in Section 5.3.
Phase 2 Trial means a human clinical trial conducted on study subjects with the disease or condition being studied for the principal purpose of achieving a preliminary determination of efficacy or appropriate dosage ranges, as further described in 21 C.F.R. §312.21(b) (including any such clinical study in any country other than the United States).
Milestone Event has the meaning set forth in Section 8.2.1.
Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.
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).
Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.
Pivotal Clinical Trial means a human clinical trial in any country that is prospectively designed to generate data intended to satisfy the requirements of 21 C.F.R. § 312.21(c) (as amended) in the U.S. or a similar clinical study prescribed by a Regulatory Authority from another country, from time to time, pursuant to Applicable Law.
Supplier/ Successful or Selected bidder means the person, private or government entity, or a combination of the above, whose Bid to perform the Contract has been accepted by the Purchaser and is named as such in the Agreement, and includes the legal successors or permitted assigns of the successful/ selected bidder.
Phase 1 Study means a clinical study of a drug candidate in human patients with the primary objective of characterizing its safety, tolerability, and pharmacokinetics and identifying a recommended dose and regimen for future studies as described in 21 C.F.R. §312.21(a), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The drug candidate can be administered to patients as a single agent or in combination with other investigational or marketed agents.
POC means Point of Compliance. "POE" means Point of Exposure. "PSI" means pounds per square inch.