Phase 1 Data Package definition

Phase 1 Data Package means, with respect to a given Program for which a Phase 1 Clinical Trial is conducted, the following: (i) a reasonably detailed analysis of the data and applicable endpoints of the Phase 1 Clinical Trial after Data Lock (“Phase 1 Data”), including [***]; (ii) [***]; (iii) [***]; (iv) [***]; (v) [***]; (vi) [***]; (vii) [***]; (viii) [***]; (ix) [***]; (x) [***]; (xi) [***]; (xii) a list of [***], as well as a [***]; and (xiii) [***].
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Phase 1 Data Package means the following: (a) a reasonably detailed analysis of the data and applicable endpoints of the PRX019 Phase 1 Clinical Trial after Data Lock (“Phase 1 Data”), including the investigational medicinal product dossier and the investigator’s brochure; (b) protein, amino acid and nucleotide sequence information for the Licensed Antibody(ies) thereunder, including the imaging agents and surrogate Antibody(ies) for preclinical use, if any, used in connection therewith; (c) all indication information generated with respect to such Licensed Antibody(ies), including subject demographics, target Indication, treatment history (including duration of most recent response or period of stable disease); (d) all safety and tolerability information generated with respect to such Licensed Antibody(ies), including nature, incidence and severity of adverse events (both drug related and overall) in relation to dose, any abnormalities in laboratory values, ECG parameters, xxxxx xxxxx, or physical/neurological examination, and the non-tolerated dose and dose limiting toxicities that defined the maximum tolerated dose; (e) all pharmacokinetics information generated with respect to such CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. Licensed Antibody(ies), including parameters (e.g., Cmax, Tmax, AUC, all with coefficients of variation) in relation to dose as well as pre-dose samples and characterization for each readout for each trial participant; (f) all pharmacodynamics information generated with respect to such Licensed Antibody(ies), including clear evidence for dose responsive target engagement or pharmacodynamics that indicates that such Licensed Antibody(ies) is pharmacologically active and helps establish proof of mechanism and an appropriate dose range with sufficient safety margins for a Phase 1b/Phase 2 Clinical Trial expansion, as well as desired pharmacodynamics marker responses that should be supported by pre-clinical/non-clinical data; (g) all preliminary safety and efficacy information generated with respect to such Licensed Antibody(ies), including standard response criteria; (h) all dosing and exposure information generated with respect to such Licensed Antibody(ies), including days of dosing, cumulative dose intensity and dose modifications; (i) all patient selection information generated with respect ...
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Phase 1 Data Package means the manufacturing and controls, regulatory, quality and any other Data relating to the first Phase 1 Clinical Study (including the reports for such Phase 1 Clinical Study). An updated list of Patent Rights Controlled by Servier or Pfizer, as applicable, that are associated with such Phase 1 Data Package shall be included therein.
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Examples of Phase 1 Data Package in a sentence

  • For the avoidance of doubt, if Celgene has exercised its IND Option for a given Program, the Phase 1 Development Portion of the Collaboration with respect to such Program may continue beyond the end of the Research Term until delivery of the Phase 1 Data Package for such Program.

  • If Celgene designates a Third Party advisor to receive the Phase 1 Data Package, such Third Party advisor shall, prior to receiving such Phase 1 Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8.

  • If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program.

  • Celgene shall have the right to exercise its Phase 1 Option with respect to such Program as set forth in Article 3 (including entering into a Global License Agreement for such Program with Prothena), with the date that Prothena so delivers the complete Phase 1 Data Package for such Program being deemed be the End of Phase 1 Date for such Program, and the provisions of Article 3 shall apply in connection therewith, mutatis mutandis.

  • Confidential treatment has been requested with respect to the omitted portions.shall, no later than [***] ([***]) days after receiving such Phase 1 Data Package, notify Prothena of [***].

  • Protagonist shall use Diligent Efforts to complete the clinical study report for the Phase 1 Clinical Trial of the Initial Product set forth in the Clinical Development Plan as promptly as is practicable following the delivery of the Phase 1 Data Package, and shall deliver such clinical study report to Xxxxxxx promptly following its completion (and, in any event, no later than [ * ] after the Phase 1 Completion Date).

  • Following Xxxxxxx’x receipt of a complete Phase 1 Data Package pursuant to Section 3.3.2, the JSC shall meet to discuss such Phase 1 Data Package and determine whether the results from the Phase 1 Activities support continuation of preparation and conduct of the CD Phase 2 Clinical Trial and related Phase 2 Activities.

  • Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) shall, no later than [***] ([***]) days after receiving such Phase 1 Data Package, notify Prothena of [***].

  • Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission.

  • Upon reception by Servier of each Phase 1 Data Package, Servier shall have the opportunity during [***] to raise questions regarding the Phase 1 Data Package and the Candidate Product.


More Definitions of Phase 1 Data Package

Phase 1 Data Package means, with respect to a Compound directed to an Available Target, the following: (i) the final and complete clinical study report for the Phase 1 Clinical Trial of such Compound, based on an analysis performed on the complete and cleaned dataset from such Phase 1 Clinical Trial, (ii) chemical structure information for such Compound, (iii) all safety and efficacy data generated with respect to such Compound and all correspondence to and from any Regulatory Authority regarding such Compound, and (iv) a reasonably detailed summary of any other research and development activities conducted with respect to such Compound, including any data generated in connection therewith; provided that, EPIZYME shall use Commercially Reasonable Efforts to conduct a follow-up of patients in the Phase I Clinical Trial of such Compound, as set forth in the applicable protocol, and shall include the results of any such follow-up that is conducted in the Phase 1 Data Package to the extent available at such time as the Phase 1 Data Package is otherwise complete.
Sample 1
Phase 1 Data Package means the following: (a) a reasonably detailed analysis of the data and applicable endpoints of the PRX019 Phase 1 Clinical Trial after Data Lock (“Phase 1 Data”), including the investigational medicinal product dossier and the investigator’s brochure; (b) protein, amino acid and nucleotide sequence information for the Licensed Antibody(ies) thereunder, including the imaging agents and surrogate Antibody(ies) for preclinical use, if any, used in connection therewith; (c) all indication information generated with respect to such Licensed Antibody(ies), including subject demographics, target Indication, treatment history (including duration of most recent response or period of stable disease); (d) all safety and tolerability information generated with respect to such Licensed Antibody(ies), including nature, incidence and severity of adverse events (both drug related and overall) in relation to dose, any abnormalities in laboratory values, ECG parameters, vital signs, or physical/neurological examination, and the non-tolerated dose and dose limiting toxicities that defined the maximum tolerated dose; (e) all pharmacokinetics information generated with respect to such
Sample 1
Phase 1 Data Package means, with respect to a Compound directed to an Available Target, the following: (i) the final and complete clinical study report for the Phase 1 Clinical Trial of such Compound, based on an analysis performed on the complete and cleaned dataset from such Phase 1 Clinical Trial, (ii) chemical structure information for such Compound, (iii) all safety and efficacy data generated with respect to such Compound and all correspondence
Sample 1

Related to Phase 1 Data Package

  • Data Package has the meaning set forth in Section 2.9(a).

  • 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.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States 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).

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Phase 1 Trial means, with respect to a Licensed Product, a clinical trial (or — in case of a multi-phase clinical trial — those parts of a clinical trial) in line with the provisions of 21CFR312, Section 21 (a).

  • Phase 2 Clinical Trial means a human clinical trial, for which the primary endpoints include a determination of dose ranges or an indication of efficacy in patients being studied as described in 21 C.F.R. §312.21(b), or an equivalent clinical trial in a country in the Territory other than the United States.

  • 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.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • 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 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.

  • 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 I Trial means a Clinical Trial, the principal purpose of which is preliminary determination of safety of an investigational product in healthy individuals or patients or that otherwise meets the requirements described in 21 C.F.R. §312.21(a), or similar Clinical Trial in a country other than the United States.

  • Phase II Clinical Trial means a controlled human clinical study that would satisfy the requirements of 21 CFR 312.21(b), conducted to study the effectiveness and establish the dose range of a Product for a particular Indication in patients with the disease or condition under study, including a Phase IIA Clinical Study or Phase IIB Clinical Study.

  • 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.

  • 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 III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • 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 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.

  • Clinical Study means a Phase I Study, Phase II Study, Phase III Study, as applicable.

  • Phase 3 Study means a clinical study of a drug candidate in human patients that incorporates accepted endpoints for confirmation of statistical significance of efficacy and safety with the aim to obtain Regulatory Approval in any country as described in 21 C.F.R. 312.21(c), or a comparable clinical study prescribed by the relevant Regulatory Authority in a country other than the United States. The relevant drug candidate may be administered to patients as a single agent or in combination with other investigational or marketed agents.

  • Phase III Clinical Trial means a human clinical trial of a product, the design of which is acknowledged by the FDA to be sufficient for such clinical trial to satisfy the requirements of 21 C.F.R. 312.21(c) (as amended or any replacement thereof), or a similar human clinical trial prescribed by the Regulatory Authority in a country other than the United States, the design of which is acknowledged by such Regulatory Authority to be sufficient for such clinical trial to satisfy the requirements of a pivotal efficacy and safety clinical trial.

  • Phase 1 means the phase of the ATP comprised of: (1) improvements to the State Street Substation; (2) construction of the Proposed Line; (3) the rebuilding of NYSEG’s existing Lines 971 and 000 xxxxx xx Xxxxxxxx Xxxx xx the NYSEG ROW to allow for construction of the Proposed Line as intended; (4) improvements to the Elbridge Substation to accept the Proposed Line; and (5) National Grid’s conveyance to NYSEG of the NYSEG Acquired ROW and such other land interests as contemplated by the Purchase and Sale Agreement.

  • Work package means a major sub-division of the proposed project.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.