Submission Milestone definition

Submission Milestone means submission by or on behalf of a Selling Entity of a new drug application to the FDA with respect to a Product for the treatment of XXXX.
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Submission Milestone means: the submission of the BLA to the FDA. The Submission Milestone is passed when the file has been delivered to, and accepted by, the FDA. The Submission Milestone ensures that all documentation determined by NN to be sufficient to satisfy the applicable requirements for Regulatory Approval is completed and collected and that the BLA is received by the FDA.
Sample 1
Submission Milestone means satisfaction of each of the following events: (a) no Default or Event of Default shall have occurred and be continuing, and (b) the FDA’s acceptance for the filing of the NDA submitted by Borrower for Avacopan for the treatment of AAV.
Sample 1

Examples of Submission Milestone in a sentence

  • Upon exercise of the Option, Ophthotech is required to pay AVEO a fee of $2 million in addition to the IND Submission Milestone Payment if such payment has not then been previously paid.

  • Subject to the terms and conditions of this Agreement and Borrower’s satisfaction of the Submission Milestone, beginning on the New Loan Effective Date, and continuing through December 15, 2020, Borrower may request, and if requested, Lender shall make New Loan Tranche B Advances in an aggregate principal amount up to $20,000,000 in minimum increments of $1,000,000.

  • This haze reflects some sunlight back to space, and can have a small, cooling effect on climate.

  • Thereafter the land should revert to cultivation using normal agricultural machinery for the area.

  • The following highlighted pages appear in the Thesis Submission Milestone.

  • Monsanto Canada shall pay or cause to be paid to Protiva, within thirty (30) days after achievement of the Post-Closing Plant Submission Milestone, [***] by electronic wire as arranged with Protiva.

  • Table 2: Demolition Design Stage Submission Milestone Dates The timeframe for the Contracting Authority accepting the Construction Manager’s GMP Amendment for the demolition of Boyd E.

  • Towards Submission Milestone Review (Master of Research Practice not applicable ) Date Approved/Achieved:5.

  • This Invitation does not require any approval from or filing with the Polish Financial Supervision Authority or any other public authority.This Invitation was published on 3rd of September 2021.

  • If Isis assigns its rights in the Licensed Technology to any person it shall do so expressly subject to the Licensee’s rights under this Agreement.Portions herein identified by [*****] have been omitted as Confidential Information and has been filed separately with the Securities and Exchange Commission.

Related to Submission Milestone

  • Project Milestone means the project milestone set forth in Schedule-J;

  • Project Milestones means the project milestones set forth in Schedule-G;

  • Development Milestone Event has the meaning set forth in Section 7.1.

  • Milestone 2 means achievement of annual Net Sales of at least $35,000,000 during any Calendar Year ending on or before December 31, 2024.

  • Milestone Event has the meaning set forth in Section 8.4.

  • Milestone 1 means achievement of annual Net Sales of at least $20,000,000 during the Calendar Year ending on December 31, 2021.

  • Milestone Events has the meaning set forth in Section 3.3 (Milestone Payments).

  • Milestone Date means the date set against the relevant Milestone in the Implementation Plan;

  • Milestone Schedule means Seller’s milestone schedule, the form of which is attached to this Agreement as Exhibit Q.

  • Performance Milestone means an act or event specified in section 5.1 and described in section 9 of the EPLA.

  • Milestone means an event or task described in the Implementation Plan which, if applicable, must be completed by the relevant Milestone Date;

  • Development Milestone Payment shall have the meaning set forth in Section 9.2(a).

  • Milestone Dates means the dates for completion of specified Project activities as contained in the Project Schedule.

  • Milestones means control points in the project that help to chart progress. Milestones may correspond to the completion of a key deliverable, allowing the next phase of the work to begin. They may also be needed at intermediary points so that, if problems have arisen, corrective measures can be taken. A milestone may be a critical decision point in the project where, for example, the consortium must decide which of several technologies to adopt for further development.

  • Sales Milestone Payment is defined in Section 5.3.

  • Timeline means the list of critical dates and actions included in the Introductory Materials.

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

  • Phase 2 Clinical Trial means a human clinical trial of a product in any country that would satisfy the requirements of 21 C.F.R. 312.21(b) and is intended to explore a variety of doses, dose response, and duration of effect, and to generate initial evidence of clinical safety and activity in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.

  • Milestone Failure means a failure by the Grant Recipient fully to achieve any Milestone by the relevant Milestone Date;

  • Final Completion means the date determined and certified by A/E and Owner on which the Work is fully and satisfactorily complete in accordance with the Contract.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase 1 Clinical Trial means a Clinical Trial of a Product on sufficient numbers of normal volunteers and/or patients that is designed to establish that such Product is safe for its intended use and to support its continued testing in Phase 2 Clinical Trials. For purposes of this Agreement, ‘initiation’ of a Phase 1 Clinical Trial for a Product means the first dosing of such Product in a human subject in a Phase 1 Clinical Trial.

  • Pivotal Clinical Trial means, with respect to a Licensed Product, (a) a phase 3 Clinical Trial or (b) any other clinical trial that is intended (as of the time the study is initiated) to obtain the results and data to support (without the need to conduct any additional clinical trial) the filing of an application for Regulatory Approval for such product.

  • Phase III Study means a human clinical trial that is prospectively designed to demonstrate statistically whether a product is safe and effective for use in humans in a manner sufficient to obtain regulatory approval to market such product in patients having the disease or condition being studied as described in 21 C.F.R. § 312.21(c) (FDCA), as amended from time to time, and the foreign equivalent thereof.

  • Phase II Clinical Study means a human clinical study of a product initiated to determine the safety and efficacy in the target patient population, as described 21 C.F.R. 312.21(b).

  • Phase III Clinical Study means a human clinical study of a product on a sufficient number of subjects that is designed to establish that such product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with such product in the dosage range to be prescribed, which trial is intended to support Regulatory Approval of such product, as described in 21 C.F.R. 312.21(c). 1.185. [***] 1.186. [***]