First IND definition

First IND means the first acceptance for filing of a submission by Avanir or any of its Affiliates or sublicensees of an IND in the U.S., EU or Japan for any Licensed Product.
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First IND means the IND for the First Phase I Study.
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First IND means IND # 18124 submitted by or on behalf of Dimension to the FDA on or about April 12, 2018, as may be amended from time to time.
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Examples of First IND in a sentence

  • On each anniversary of the First IND Date thereafter during the Term, Bellicum shall pay to BioVec a nonrefundable license maintenance fee of one hundred and fifty thousand U.S. dollars ($150,000 USD).

  • Avanir shall send a draft manuscript of any such publication proposed to be published before the First IND of a Licensed Product by FDA or EMA to Concert for review at least [**] days before the date on which Avanir plans to submit the proposed submission for publication, and as to any such proposed publications before First IND Concert may provide comments thereon to Avanir.

  • Notwithstanding anything to the contrary in Article 8, Avanir may publish any data within the Concert Technology, Collaboration Technology or otherwise resulting from Clinical Trials conducted on a Licensed Product, subject to the JSC’s review and approval of all such proposed publications before First IND, and thereafter in Avanir’s discretion without review by the JSC or Concert.

  • After First IND, any additional activities undertaken in the Development Program or conducted at Avanir’s request pursuant to Section 3.4.5 or Section 3.8 by Concert would be upon written agreement of the Parties, but at the rate of [**] U.S. Dollars ($[**]) per FTE.

  • If Concert has any comments as to any such proposed publications before First IND, Concert shall provide its written comment on the publication within [**] days from receipt of the draft.

  • Until First IND, Avanir will provide Concert an opportunity to provide comments, but not approval, if and to the extent reasonably possible under the circumstances and permitted in accordance with applicable Law (as determined by outside legal counsel of Avanir) of any such press releases by Avanir.

  • Avanir will pay Concert for Concert’s activities actually conducted under the Development Program or conducted at Avanir’s request pursuant to Section 3.4.5 or Section 3.8 at the rate of [**] U.S. Dollars ($[**]) per FTE (prorated for partial FTEs as appropriate) until First IND, subject in the case of Development Plan activities to the maximum amount of FTEs to be reimbursed for each of Concert’s activities specified in the Development Plan.

  • Either Party may subcontract any of its obligations under this Agreement with the prior written consent of the JSC; provided, however, that no such consent is required by Avanir after First IND.

  • The detail of this notification procedure shall be agreed separately from this Agreement by a pharmacovigilance agreement which shall be executed between the parties by the time when AnHeart, its Affiliate, or Sublicensee makes an application for the First IND.

  • Other than the First IND, all regulatory filings submitted in connection with obtaining Marketing Authorizations to test or market a Collaboration Compound or Product, including all IND, MAA and NDA submissions and other regulatory filings relating to the Collaboration Compounds and Products, shall be owned by and submitted by and in the name of, Novartis, its Affiliates or its designees.

Related to First IND

  • First Commercial Sale means, with respect to any Licensed Product, the first sale for use or consumption by the general public of such Licensed Product in any country in the Territory after Approval of such Licensed Product has been granted, or such marketing and sale is otherwise permitted, by the Regulatory Authority of such country.

  • NPCC means the Northeast Power Coordinating Council, Inc. (a reliability council under Section 202 of the Federal Power Act) or any successor organization.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • PMA means the annual product multiplier and/or seasonal factor as appropriate for Gas Year “t”, in accordance with the Gas Product Multipliers and Time Factors Table.