IND Data Package definition

IND Data Package means, with respect a given Program for which an IND has been Filed with the FDA, the following: (i) a reasonably detailed analysis of the key data related to the Lead Candidate(s) from such Program, (ii) [***], (iii) [***], (iv) [***], (v) a list of [***], as well as a [***], and (vi) [***].
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IND Data Package shall have the meaning provided in Section 2.10.
Sample 1
IND Data Package has the meaning set forth in Section 6.4(a).
Sample 1

Examples of IND Data Package in a sentence

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

  • Within [***] ([***]) days after Filing of the first IND with the FDA for a Lead Candidate from a given Program ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the IND Data Package for such Program (which, for clarity, shall specify all then-existing Lead Candidates from such Program).

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

  • Following completion of IND-Enabling Studies for a given Joint SAV Program, the Party that conducted such IND-Enabling Studies will promptly prepare and provide the other Party with the SAV IND Data Package for such Joint SAV Program.

  • Xxxxxxx shall make the IND application decision no later than [***] days after the IND Data Package Delivery Date for [***].

  • Upon receipt of the IND Data Package, CELGENE (or its designee) shall have [**] days to review such IND Data Package and CELGENE (or its designee) shall notify EPIZYME within [**] days of receipt of any reasonable additional information and records related to such Development Candidate that CELGENE desires (such right to request additional information to be limited to a single request within such period), and EPIZYME shall respond to such request within [**] days thereof.

  • Werewolf shall promptly provide to Jazz any data or information that Jazz identifies as missing from such IND Data Package and shall promptly provide responses to Jazz’s inquiries for clarification regarding the data and information included in such IND Data Package.

  • For each Research Program with respect to a Xxxxxxx Antigen, the Research Plan shall describe the contents of the DC Data Package and IND Data Package for such Research Program.

  • If CELGENE designates a Third Party advisor to receive the IND Data Package, such Third Party advisor shall agree to be bound by confidentiality obligations consistent with those set forth in Article 9 and shall only provide to CELGENE a written report summarizing its conclusions regarding the suitability of such Development Candidate for further Development and Commercialization and shall not provide to CELGENE the IND Data Package.


More Definitions of IND Data Package

IND Data Package means a collection of all then-available information, data, and results from IND Enabling Studies for such Pre-IND Collaboration Candidate. Fate will include in the IND Data Package evidence of the early phase CMC Development process for such Pre-IND Collaboration Candidate, with data demonstrating process manufacturability for future adaption into the pivotal and commercial Manufacturing process.
Sample 1
IND Data Package means, with respect to a Compound directed to an Available Target for which EPIZYME proposes to file an IND in the United States or a Major EU Country and conduct a Phase 1 Clinical Trial, the following: (i) a reasonably detailed summary of any research and development activities conducted with respect to such Compound, including any data generated in connection therewith, (ii) chemical structure information for such Compound, (iii) the draft IND for such Compound and all correspondence to and from any Regulatory Authority regarding such Compound, and (iv) the information and data set forth in Schedule 1.35 with respect to such Compound.
Sample 1
IND Data Package means, with respect to a Compound directed to an Available Target for which EPIZYME proposes to file an IND in the United States or a Major EU Country and conduct a Phase 1 Clinical Trial, the following: (i) a reasonably detailed summary of any research and development activities conducted with respect to such Compound, including any data generated in connection therewith, (ii) chemical structure information for such Compound, (iii) the draft IND for such Compound and all correspondence to and from any Regulatory Authority regarding such Compound, and (iv) the information and data set forth in S chedule 1.35 with respect to such Compound.
Sample 1

Related to IND 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).

  • Third-party filer means an entity that submits a Product filing to the Commission on behalf of an Insurer.

  • 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 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 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 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 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 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 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 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 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.

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

  • 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)).

  • 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.

  • 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.

  • GSK has the meaning set forth in the preamble.

  • 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.

  • Product Candidate means any pharmaceutical product developed, manufactured and/or tested by or on behalf of the Company that has not received a Regulatory Authorization for commercial distribution other than in connection with pre-clinical or clinical trials.

  • 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).

  • Study Data shall have the meaning set forth in Section 8.1.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • Licensed Compounds means: (a) Research Program Active Compounds; (b) Novartis Active Compounds; (c) salts, hydrates, solvates, esters, metabolites, intermediates, stereoisomers and polymorphs of Research Program Active Compounds or Novartis Active Compounds; and (d) prodrugs of Research Program Active Compounds or Novartis Active Compounds (any of the foregoing, a “Licensed Compound”).

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • 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 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.