Target Product Profile definition

Target Product Profile means the product criteria set forth in Exhibit A.

Target Product Profile or “TPP” means, with respect to a given R&D Program, collectively, [***].

Target Product Profile means [ * ].

Examples of Target Product Profile in a sentence

• Within [***] of the designation of an Elected Candidate, Merck shall update, if required, the Target Product Profile from which such Elected Candidate was selected by providing written notice to Moderna of [***].

• Within [***] of the designation of a Back-Up Elected Candidate, Merck shall update, if required, the Target Product Profile from which such Back-Up Elected Candidate was selected by providing written notice to Moderna of [***].

• APPENDIX B Respiratory Syncytial Virus Vaccine - Target Product Profile Executive Summary Variable Minimum The minimal target should be considered as a potential go/no go decision point.

• The Target Product Profile Template in Appendix C of the draft guidance details the suggested information to be included in each section of the TPP.

• Using the Target Product Profile as a guide in its decision making, ChemoCentryx shall conduct all studies it determines appropriate, applying at all times its Diligent Efforts, and shall select such Collaboration Compound it determines has met the Development Candidate Criteria and is appropriate for nomination by the JSC as a Development Candidate, and shall propose to the JSC such Collaboration Compound as a Development Candidate.

More Definitions of Target Product Profile

Target Product Profile or "TPP" means, with respect to each Target, the projected product profile that describes the commercially relevant range of acceptable product performance of a Collaboration Compound against key product characteristics, which shall be used by the Parties to guide and shape the progression of and development decisions for Collaboration Compounds directed toward such Target.

Target Product Profile or “TPP” means a description of Product performance aspirations for launch, established by GSK and OncoMed pursuant to Section 3.4.4.

Target Product Profile or “TPP” shall mean, with respect to a given Development Candidate or class of compounds, and a given Indication, the targeted attributes for an aspirational drug product for the treatment and/or prophylaxis of such Indication. These attributes will be determined through an understanding of current and future unmet medical and market needs, and of the product performance necessary for Regulatory Approval and ***Confidential Treatment Requested competitive differentiation at the time of anticipated launch. By way of guideline only, a TPP typically contains information on at least the following parameters: [...***...].

Target Product Profile shall have the meaning provided in Section 5.1(a).

Target Product Profile or “TPP” shall mean the set of potential characteristics and attributes for the Drug Product, described in Schedule 5 hereto, and revised from time to time by mutual consent through the JSC;

Target Product Profile or “TPP” means, with respect to a given Development Candidate or class of compounds, and a given Indication, the desired and required attributes for an aspirational drug product based thereon to treat, delay or prevent such Indication. These attributes will be determined through an understanding of current and future unmet medical and market needs, and of the product performance necessary for regulatory approval and competitive differentiation at the time of anticipated launch. A TPP should contain information on at least the following parameters: Indication(s); Summary product proposition (e.g. improved symptom reliever, disease modifier); Target label summary - outline basis for regulatory approval; Target patients for drug - segment(s) of patient population for whom drug would be most relevant; Clinical efficacy - key endpoints, acceptable clinical effects versus baseline and placebo, main comparators; Safety and tolerability – acceptable/unacceptable level and types of adverse events, contra-indications, drug interactions; Presentation/administration - route and frequency of administration; Cost of Goods – target threshold level for cost of goods for finished commercial product; Competitive set - current gold standard and treatment options, those expected at time of potential TPP launch; Timing information – time period of future product launch for which TPP is relevant (e.g. for 2015-2020 launch).

Target Product Profile means the target clinical profile established by Tocagen for Product, including administration, clinical use and safety, as such profile may be updated from time to time by Tocagen in its discretion.