Product Candidate means each biological and drug candidate, compound or other device or product being developed, labeled, manufactured, marketed, sold and/or distributed by the Company or a Company Subsidiary, or regarding which the Company or a Company has rights, and including any such biological and drug candidate, compound or product that has received Marketing Approval.
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.
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.
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.
Collaboration Target means the Initial Collaboration Targets set forth on Exhibit F and any Additional Target or Substitute Target that is selected in accordance with Section 3.3 of this Agreement.
Successful Applicant means an “employee applicant” or “applicant” who has been offered employment within this Bargaining Unit by the Employer.
POC (Proof of Concept) means testing the Software for evaluation purposes.
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.
Lead Compound means any compound of lead other than galena which, when treated in the manner described below, yields to an aqueous solution of hydrochloric acid a quantity soluble lead compound exceeding, when calculated as lead monoxide, five percent of the dry weight of the portion taken analysis.
Successful Proponent means a Proponent who the City may award the agreement to, as a result of this RFP document.
Successful Bid means the Bid whose Financial Bid results in maximization of the value for the Corporate Debtor/stakeholders, as determined by the Liquidator;
Independent candidate means any candidate who claims not to be affiliated with a political party, and whose name has been certified on the office-type ballot at a general or special election through the filing of a statement of candidacy and nominating petition, as prescribed in section 3513.257 of the Revised Code.
continuing candidate means any candidate not deemed to be elected, and not excluded,
Collaboration Compound means any of the following: (a) FG-4592, (b) any HIF Compound (other than FG-4592) that is added to this Agreement pursuant to Section 3.6, and (c) any salts, esters, complexes, chelates, crystalline and amorphous morphic forms, pegylated forms, enantiomers (excluding regioisomers), prodrugs, solvates, metabolites and catabolites of any of the foregoing ((a) or (b)).
Replacement Candidate means any Candidate Introduced by the Agency to the Client to fill the Engagement following the Introduction of another Candidate whose Engagement either did not commence or was terminated during the first 12 weeks of the Engagement;
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 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 Remarketing means, as applicable, a Successful Optional Remarketing or a Successful Final Remarketing.
Back-Up Compound means, with reference to any particular Development Candidate or Drug Product Candidate, a Compound which (a) has the same principal mode of action (i.e., Potentiator or Corrector) as that Development Candidate or Drug Product Candidate; and (b) was among the group of Compounds, identified by VERTEX as potential additional lead molecules having the same principal mode of action, from which the Development Candidate was selected.
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.
Successful Bidder As defined in Section 7.01(c).
Selected Bidder or Successful Bidder means the Bidder selected pursuant to this RfS to set up the Project and supply electrical output as per the terms of PPA.
Successful Bidder(s) means the bidder(s) to whom work in this tender is awarded.
Collaboration Product means any pharmaceutical product in finished form that contains a Collaboration Compound, either as the sole active ingredient or in combination with one or more other active ingredients, and all present and future formulations, dosages and dosage forms thereof.
Initiating tribunal means the tribunal of a state or foreign country from which a petition or comparable pleading is forwarded or in which a petition or comparable pleading is filed for forwarding to another state or foreign country.
Clinical Study means a Xxxxx 0 Xxxxx, Xxxxx 2 Study, Phase 3 Study, Post-Marketing Study, Supplemental Study or other study (including a non-interventional study) in humans to obtain information regarding the product, including information relating to the safety, tolerability, pharmacological activity, pharmacokinetics, dose ranging or efficacy of the product.