Successful Proof of Concept definition

Successful Proof of Concept means, with respect to a Licensed Product, initial evidence of therapeutic activity and safety (safety in patients receiving ASN007 is defined as: <10% ASN007-related SAEs, <20% ASN007-related Grade 3+ AEs, <20% of patients discontinue due to an ASN007-related AE, and no ASN007-related deaths) in an indication obtained in a Phase 2 Clinical Trial that warrants continued clinical evaluation and development in a Registrational Trial, including an extension or continuation of such Phase 2 Clinical Trial that would serve as the Registrational Trial for such Licensed Product. Without limiting the generality of the foregoing, a Licensed Product will be deemed to warrant continued clinical evaluation development in a Registrational Trial in an indication upon the earliest of (A) the achievement of the applicable success criteria set forth in Exhibit 1.50, (B) the date on which a final protocol for such Registrational Trial has been signed by a duly authorized officer of Parent or (C) Parent’s receipt of the FDA’s minutes from an end-of-phase 2 meeting between Parent and the FDA with respect to such Phase 2 Clinical Trial, indicating that the dose and safety and efficacy data from the Phase 2 Clinical Trial are sufficient to proceed to a Registrational Trial of the Licensed Product.
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Successful Proof of Concept has the meaning set forth in Annex A hereto.
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Successful Proof of Concept shall have the meaning assigned to such term in Section 3.1(a).
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Examples of Successful Proof of Concept in a sentence

  • Successful Proof of Concept of Family Planning and Immunization Integration in Liberia.

  • Step 4: Design An Example of a Successful Proof of Concept| ETL | Expert ...The Blueprint helps you create a compelling proof of concept.

  • Eligible Buyer shall, within five (5) working days after the date of this Agreement, make diligent and truthful application to the lender and furnish to the City and the lender such information, forms or other materials as may be required by such lender within fifteen (15) working days after the date of this Agreement.


More Definitions of Successful Proof of Concept

Successful Proof of Concept means agreement of the Parties in writing that there exists evidence of an effect (whether a clinical outcome or other bio marker) indicating a high chance of achieving a result of a Phase III Clinical Trial in an indication in which the Licensed Product concerned could be expected to generate peak Annual Net Sales of at least *** U.S. Dollars ($***), or initiation of the next step of clinical assessment by AstraZeneca after having discovered such effect.
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Successful Proof of Concept shall have the meaning assigned to such term in Section 3.1(a). 1.40 “Target A Royalty Rate” means [***]. 1.41 “Target Formulations” shall mean either Target [***] and/or Target [***]. 1.42 “Target [***]” shall mean [***]. 1.43 “Target [***] Patent Right” means any patents and patent applications Covering Target [***] conceived or reduced to practice by Core, issued patents resulting from such applications, and all divisions, continuations, substitutions, reissues, extensions, registrations, patent term extensions and renewals of the foregoing. 1.44 “Target [***] Royalty Period” shall have the meaning assigned to such term in Section 3.1(d)(i). 1.45 “Target [***]” shall mean [***]. 1.46 “Target [***] Patent Right” means any patents and patent applications Covering Target [***] conceived or reduced to practice by Core, issued patents resulting from such Note: Certain material has been redacted from this document and filed separately with the SEC pursuant to a request for confidential treatment under Rule 24b-2. The locations of these redactions are indicated throughout the document by the following marking: [***].
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Related to Successful Proof of Concept

  • Proof of Concept has the meaning set forth in Section 2.3.

  • Successful Proponent means a Proponent who the City may award the agreement to, as a result of this RFP document.

  • Successful Applicant means an “employee applicant” or “applicant” who has been offered employment within this Bargaining Unit by the Employer.

  • 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 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 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 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;

  • Targeted Unsuccessful Security Incident means an Unsuccessful Security Incident that appears to be an attempt to obtain unauthorized Access, Use, Disclosure, modification or destruction of the Covered Entity’s Electronic PHI.

  • 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

  • Phase III Trial means a human Clinical Trial of the Licensed Product, which trial is designed (a) to establish that the Licensed Product is safe and efficacious for its intended use; (b) to define warnings, precautions and adverse reactions that are associated with the Licensed Product in the dosage range to be prescribed; and (c) consistent with 21 CFR § 312.21(c).

  • Successful Syndication shall have the meaning given to such term in the Fee Letter.

  • Unsuccessful Security Incident means a Security Incident such as routine occurrences that do not result in unauthorized Access, Use, Disclosure, modification, or destruction of information or interference with system operations in an Information System, such as: (i) unsuccessful attempts to penetrate computer networks or services maintained by Business Associate; and (ii) immaterial incidents such as pings and other broadcast attacks on Business Associate's firewall, port scans, unsuccessful log-on attempts, denials of service and any combination of the above with respect to Business Associate’s Information System.

  • Final Approval Order and Judgment means the order in which the Court certifies the Settlement Class, grants final approval of this Settlement Agreement, authorizes the entry of a final judgment, and dismisses the Action with prejudice.

  • 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 Security Incident means a Security Incident that results in the unauthorized Access, Use, Disclosure, modification, or destruction of information or interference with system operations in an Information System.

  • proof of B-BBEE status level of contributor means:B-BBEE Status level certificate issued by an authorized body or person;A sworn affidavit as prescribed by the B-BBEE Codes of Good Practice;Any other requirement prescribed in terms of the B-BBEE Act;

  • Phase II Trial means a clinical trial of a Licensed Product on patients, including possibly pharmacokinetic and dose ranging studies, the principal purposes of which are to make a preliminary determination that such Licensed Product is safe for its intended use and to obtain sufficient information about such Licensed Product’s efficacy to permit the design of further clinical trials, and generally consistent with 21 CFR §312.21(b), or its successor regulation, or the equivalent in any foreign country.

  • Phase I Trial means a clinical trial of a Licensed Product in human patients conducted primarily for the purpose of determining the safety, tolerability and preliminary activity of the Licensed Product, including, without limitation, for determining the maximum tolerated dose, or optimal dose. For purposes of this Agreement, a Phase I trial shall specifically exclude a study in healthy volunteers.

  • 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).

  • Final Approval Hearing means the hearing before the Court where the Parties will request the Final Judgment to be entered by the Court approving the Settlement Agreement, the Fee Award, and the incentive award to the Class Representative.

  • Proof of Claim means a proof of Claim Filed against any of the Debtors in the Chapter 11 Cases.

  • Phase 3 Trial means a human clinical trial of a Product on a sufficient number of subjects that is designed to establish that a pharmaceutical product is safe and efficacious for its intended use, and to determine warnings, precautions and adverse reactions that are associated with such pharmaceutical product in the dosage range to be prescribed, which trial is intended to support Approval of a Product, as described in 21 C.F.R. 312.21(c) for the United States, or a similar clinical study prescribed by the Regulatory Authorities in a foreign country.

  • 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.

  • Proof of Interest means a proof of Interest Filed against any of the Debtors in the Chapter 11 Cases.

  • 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.

  • Successful Respondent means an organization that receives a grant award as a result of this RFA. May also be referred to as "Grantee, ""Awarded Applicant," "Subrecipient" or "Grant Recipient."