IND Submission definition

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 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.

IND Submission means the submission of an IND to a Regulatory Authority in a Major Market Country.

Examples of IND Submission in a sentence

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.
Once the Proposed IND Submission has been approved by the JSC pursuant to Section 5.1.2(a), the [**] shall not be changed.
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.
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.
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.
Once such an IND submission package has been agreed on by the Joint Steering Committee, Proposed IND Submission for the purposes of Section 14 and the financial terms set forth in Exhibit 1 shall be deemed reached.
As part of any Research Plan, upon the Parties’ mutual agreement, MeiraGTx may initiate Natural History Studies prior to any IND Submission with respect to the applicable Research IRD Target Indication associated with such Research IRD Target.

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.

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.

IND Submission means the date that Voyager submits an IND to the FDA for a Covered Indication with respect to a Licensed Product.