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. [***] [***] CONFIDENTIAL MATERIAL REDACTED AND SEPARATELY FILED WITH THE COMMISSION. 45 / 56
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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
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Examples of Phase 1 Data Package in a sentence

  • 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.

  • 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.

  • 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.

  • 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 [***].

  • 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.

  • 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 [***].

  • 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 .

  • 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.


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.
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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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Related to Phase 1 Data Package

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

  • 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 of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Phase II Study means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

  • Phase I Clinical Trial means a clinical trial conducted in healthy humans or patients, which clinical trial is designed to establish the safety, drug-drug interactions and/or pharmacokinetics of an investigational drug given its intended use, and to support continued testing of such drug in Phase II Clinical Trials.

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]

  • 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 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 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, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

  • 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, the principal purpose of which is to demonstrate clinically and statistically the efficacy and safety of a Licensed Product for one or more indications in order to obtain Marketing Approval of such Licensed Product for such indication(s), as further defined in 21 C.F.R. §312.21 or a similar clinical study in a country other than the United States.

  • Phase 1 means the first implementation phase of this section, beginning June 1, 2018 and ending May 31, 2022.

  • 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.

  • 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).

  • Development Plan has the meaning set forth in Section 3.2.