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.

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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

• 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).

• 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 ▇▇▇▇▇▇▇ notice thereof on or before the end of such Maximum Efforts Period.

• Sanofi hereby assumes all regulatory responsibilities in connection with Licensed Compounds and Products after IND Approval, including sole responsibility for all Regulatory Documentation and for obtaining all Approvals.

• Prior to IND Approval (and Sanofi’s payment to Regulus of the applicable milestone under Section 6.5.1) for a given Collaboration Target, Regulus may, consistent with its practice with its other compounds and products, publish and present data regarding any such Collaboration Targets, Licensed Compounds and/or Products; provided, however, that Regulus will provide any such proposed publication to Sanofi at least 30 days prior to submission for publication or presentation.

• In the event that Company files an IND before December 31, 2006, the Milestone Payment for Receipt of IND Approval will be waived by Penn.

More Definitions of IND Approval

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 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 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, with respect to a Clinical Trial, the date on which the IND for such Clinical Trial is in effect, as set forth (as of the Original Effective Date) at 21 C.F.R. Section 312.40(b), which is the earlier of: (a) the date that is [***] following confirmation by the FDA of its receipt of such IND without imposition of a clinical hold by the FDA; or (b) the date that FDA provides notice that such Clinical Trial may begin.