IND Approval definition

IND Approval means the acceptance (or deemed acceptance) of the filing of an IND by the applicable Regulatory Authority. For purposes of clarity, acceptance (or deemed acceptance) of the filing of the foreign equivalent of an IND by the applicable Regulatory Authority in such country will be an IND Approval.

IND Approval means approval of an IND filed with the FDA.

IND Approval means, (i) with respect to an IND submitted to the FDA, the date on which the thirty (30)-day period following the receipt by the FDA of such IND has expired (or, if the FDA places a clinical hold on such IND that survives such thirty (30)-day period, the date on which such hold has been lifted without the imposition of material restrictions or conditions on the clinical trial of the applicable Development Candidate), (ii) with respect to an IND submitted to a Regulatory Authority in *****, the date such IND is approved in accordance with applicable law or the first date on which a clinical trial may be conducted in accordance with applicable law (whatever is earlier), and (iii) with respect to an IND submitted to the European Medicines Agency, the date such IND is approved in accordance with applicable law.

Examples of IND Approval in a sentence

• AstraZeneca shall and hereby does assume all regulatory responsibilities in connection with Lead Compounds and Products in the Product Field after the Development Transition Date for such Collaboration Target, including all subsequent IND submissions in countries outside the country of the Initial Major Market IND Approval.

• Thereafter during the Research Term, Regulus shall have sole responsibility for all Regulatory Documentation and follow-up with Regulatory Authorities in such Major Market in connection therewith, and for using Commercially Reasonable Efforts to obtain the first IND Approval in such Major Market (the “Initial Major Market IND Approval”).

• The Initial Major Market IND Approval filed by Regulus with respect to the relevant Lead Compound with respect to a Collaboration Target shall be in Regulus’ name.

• Following the earlier to occur of (a) Initial Major Market IND Approval with respect to a Collaboration Target and (b) the end of the Research Term (the “Development Transition Date” for such Collaboration Target), AstraZeneca will have sole responsibility, including without limitation sole responsibility for all funding, resourcing and decision-making, for all development and commercialization of such Lead Compound and all Products containing or comprising such Lead Compound in the Product Field.

• In the event that a Lead Compound is designated during the Research Term but Regulus does not obtain Initial Major Market IND Approval of such Lead Compound, the Parties agree to discuss in good faith regarding an extension of the Research Term to permit additional time for Regulus to obtain such Initial Major Market IND Approval; provided, that the Parties agree that such agreement may include additional payments to be made by AstraZeneca to Regulus to support such activities.

More Definitions of IND Approval

IND Approval means the expiration of the thirty-day waiting period for IND effectiveness, or earlier approval to proceed with clinical trial(s) under the IND, or, if a clinical hold is imposed, notification from a Division Director that the clinical trial may proceed.

IND Approval means the approval of an IND by EMA, FDA or other competent regulatory authority.

IND Approval of a Product means that an IND for such Product has been submitted to the FDA or equivalent Regulatory Authority and not rejected (including placed on clinical hold) by the FDA or equivalent Regulatory Authority within [***] days after such submission.

IND Approval means approval by the FDA of an Investigational New Drug application which permits Discovery to conduct clinical studies of the new drug in the United States.

IND Approval means, with respect to a Development Candidate, that the applicable Regulatory Authority permits such Development Candidate to be administered to humans in a Clinical Trial, including by issuing a “safe to proceed” letter or similar authorization.

IND Approval means with respect to an IND, the earlier of (a) receipt by Lilly, its Affiliate of written confirmation from a Regulatory Authority or other applicable Person that human clinical studies may proceed under such IND, and (b) expiration of the applicable waiting period after which human clinical studies may proceed under such IND.

IND Approval of a Product means that an IND for such Product has been submitted to the FDA or equivalent Regulatory Authority and not rejected (including placed on clinical hold) by the FDA or equivalent Regulatory Authority within [* * *] after such submission.