IND Submission definition

IND Submission with respect to a Venture Product means submission of an Investigational New Drug regulatory application ("Chiken Todoke" corresponding to an IND application in the U.S.) to authorities for approval to initiate any new phase of human trials of the product in a jurisdiction in the Territory.
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IND Submission means an "Investigational New Drug" application to the FDA requesting approval to initiate a clinical trial on a new drug or biological product.
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IND Submission means the submission by the Company of its first IND for G-202 as confirmed by the assignment of an IND number by the FDA.
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Examples of IND Submission in a sentence

  • IND Submission Updates and FDA Meetings This task will include submissions to the IND and possible FDA meetings that will be required prior to the BLA submission.

  • In case ADCT is the Withdrawing Party prior to providing the IND Submission and Clinical Work Plan, and Genmab does not elect to be the Continuing Party, then notwithstanding the above, Genmab may at its sole discretion decide that the Divestment Process as set forth in Article 9 shall not be initiated and that the Agreement be terminated.

  • ADCT may tile the final version of the Proposed IND Submission with the Regulatory Authority as the IND.

  • FDA IND Submission & Updates ü Sponsor will be responsible for all FDA submissions.

  • The Joint Steering Committee shall evaluate the Proposed IND Submission and proposed Clinical Work Plan, and any comments provided by Genmab and attempt, with the understanding that time and cost is of the essence (while at all times adhering to and complying with quality and regulatory requirements), to include in the initial versions of the Proposed IND Submission and the Clinical Work Plan and budgets any input provided by either Party that keep the Clinical Work Plan within the Clinical Plan Framework.

  • Genmab shall also be entitled to get access to all regulatory packages related to the Proposed IND Submission and the CMC related matters and provide input on such packages and matters, where relevant as well as all official Food and Drug Administration minutes for informational purposes.

  • Once the Proposed IND Submission has been approved by the JSC pursuant to Section 5.1.2(a), the [**] shall not be changed.

  • The JRDC shall assess the status of such Preclinical Development Activities, and, if a Development Candidate meets the IND Submission Criteria, or if the JRDC otherwise determines that an IND should be submitted for a Development Candidate, then the JRDC shall nominate such Development Candidate for IND submission to [ * ].

  • The JSC shall take into good faith consideration the comments from Genmab, but ADCT will have the casting vote on consideration of such comments and modifications, and may approve such Proposed IND Submission and proposed Clinical Work Plan and budgets, provided such are within the parameters set forth in the Clinical Plan Framework.

  • No later than thirty (30) calendar days after either Proposed IND Submission or Establishment of Clinical Proof of Concept (the Opt-Out Points), as applicable, and on a Collaboration Product-by-Collaboration Product basis, each Party (the Opt-Out Party) shall have the right to provide the other Party with irrevocable (subject to Section 15.6) notice in writing that it wishes to discontinue its participation in the further Development and Commercialization of such Collaboration Product (the Opt-Out Notice).


More Definitions of IND Submission

IND Submission means the submission of an IND to a Regulatory Authority in a Major Market Country.
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IND Submission means the collection, assembly and presentation of an Investigational New Drug application, or equivalent, to a Regulatory Authority in support of a first-in-man Phase I Trial and which has been accepted by the Regulatory Authority, thereby allowing the Phase I Trial to commence.
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IND Submission means the submission of an IND for the Licensed Product with the relevant Regulatory Authority.
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Related to IND Submission

  • Planning Submission or “CAPS” or “Community Accountability Planning Submission” means the HSP Board approved planning document submitted by the HSP to the LHIN. The form, content and scheduling of the Planning Submission will be identified by the LHIN;

  • Regulatory Submissions means any filing, application, or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Selected submission means and refers to the submission sent to the City of Waco by the Selected Firm.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • IND means (i) an investigational new drug application filed with the FDA for authorization to commence clinical studies and its equivalent in other countries or regulatory jurisdictions and (ii) all supplements and amendments that may be filed with respect to the foregoing.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • Phase I Clinical Trial means a study in humans which provides for the first introduction into humans of a product, conducted in normal volunteers or patients to generate information on product safety, tolerability, pharmacological activity or pharmacokinetics, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(a) or its foreign equivalents.

  • Phase I Clinical Study means, as to a particular Licensed Product, an initial clinical study in humans with the purpose of assessing the Licensed Product’s safety, tolerability, toxicity, pharmacokinetics or other pharmacological properties.

  • 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 IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by BMS and that otherwise fit the foregoing definition.

  • Subject of a Clinical Trial means the health care service, item, or drug that is being evaluated in the Approved Clinical Trial and that is not a Routine Patient Cost.

  • 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.

  • 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.

  • Application Review Start Date means the later date of either the date on which the District issues its written notice that the Applicant has submitted a completed Application or the date on which the Comptroller issues its written notice that the Applicant has submitted a completed Application and as further identified in Section 2.3.A of this Agreement.

  • Phase 4 Clinical Trial means a Clinical Study in any country which is conducted after Regulatory Approval of a product has been obtained from an appropriate Regulatory Authority, consisting of trials conducted voluntarily for enhancing marketing or scientific knowledge of an approved indication and trials conducted due to request or requirement of a Regulatory Authority.

  • 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.

  • Program of study means a curriculum that requires a candidate to demonstrate and document competency in the specific knowledge, skills, and dispositions for a particular endorsement to an educator’s license, a licensure content area, or level of licensure, and is:

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • Clinical Trials means a controlled study in humans of the safety or efficacy of a Product, and includes, without limitation, such clinical trials as are designed to support expanded labeling or to satisfy the requirements of an Agency in connection with any Product Approval and any other human study used in research and Development of a Product.