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 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.

Examples of IND Approval in a sentence

• In an effort to maximize understanding of the safety profile and pharmacokinetics of Regulus compounds, after IND Approval, Sanofi will cooperate with Regulus and forward safety information to Regulus designated contact persons.

• If Affimed fails to successfully develop ***** Development Candidate through IND Approval prior to the expiration of the applicable Maximum Efforts Period, it shall provide to the Company and Xxxxxxx notice thereof on or before the end of such Maximum Efforts Period.

• The goal of Phase C is to develop ***** Development Candidate through IND Approval and delivery of GMP compliant drug product of ***** Development Candidate in order to supply clinical Phase I and Phase II studies and in sufficient quantities to allow the Company (or Affimed, as the case may be) to meet the Warrant Holder CMC Objectives (as defined in the Warrant Agreement).

• 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.

• Following IND Approval, should Lilly determine that it desires to use one or more trademarks of Sigilon used in connection with the Encapsulation Technology or the Encapsulation Material for use in connection with the marketing and sale of one or more Licensed Products, it shall so inform Sigilon in writing, including a description of the use which Lilly intends to make of such Sigilon trademark.

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, (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.

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

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 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 (a) with respect to an IND filed with the FDA in the United States, the earlier of (i) notification by the FDA that the clinical investigations in the IND may begin in accordance with 21 CFR § 312.40, and (ii) thirty (30) days after the FDA receives the IND, unless the FDA provides notice that the investigations described in the IND are subject to a clinical hold under 21 CFR § 312.42; and (b) with respect to an IND filed in countries or regulatory jurisdictions outside of the United States, (i) equivalent notification received by the applicable Regulatory Authority that clinical investigations in the IND may begin, or (ii) passage of the equivalent time period (if applicable) without the applicable Regulatory Authority providing notice that clinical investigations in the IND may not begin. 1.74