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 of an IND to a Regulatory Authority in a Major Market Country.
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Examples of IND Submission in a sentence

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

  • 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.

  • 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.

  • 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.

  • 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.

  • 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 [ * ].

  • 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.

  • 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).

  • Furthermore, except for the first two Milestone payments above (IND Submission and Completion of Phase IIb Human Proof of Concept study), each Milestone payment is payable once for each Product for which the Milestone is achieved.


More Definitions of IND Submission

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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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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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 Funder. The form, content and scheduling of the Planning Submission will be identified by the Funder;

  • 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 any pricing or reimbursement approvals, as applicable, 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.