IND". IND definition

IND". IND means an application submitted to a Regulatory Authority to initiate human clinical trials, including (a) (i) a United States Investigational New Drug Application, or any successor application, and (ii) any foreign counterpart of a United States Investigational New Drug Application, and (b) all supplements and amendments that may be filed with respect to the foregoing.
View Source

Examples of IND". IND in a sentence

  • Notwithstanding the foregoing, data and documentation associated with any IND, IND Equivalents, NDAs or NDA Equivalents relating to the CMC/Process Development and Manufacture of the Compound and the Product shall be excluded from such data transfer and shall not be transferred or made available to Licensee until such time as Bayer transfers responsibility for CMC/Process Development and Manufacture of the Product to Licensee, as set forth in Section 4.3.2 below.

  • Contractor shall retain experimental records and laboratory notebooks relating to each Project, and shall maintain suitable CMC support documentation to allow Synergy or its Affiliates to file an IND, IND amendment, NDA or ANDA with the FDA.

  • Company shall provide reasonable assistance to Transferee, and its Permitted Transferees, in the preparation of and filing of any IND, IND amendment, or NDA with respect to any Covered Product for use in any Indication in the Territory.

  • Company and Company’s Affiliates shall provide (and shall make Commercially Reasonable Efforts to require any other Company Affiliate, successor, or licensee outside of the Territory to provide) reasonable assistance to Transferee (and Transferee shall reimburse for Out-of-Pocket Expenses) in the preparation of and filing of any IND, IND amendment, or NDA with respect to any Covered Product in the Territory.

  • Company shall provide reasonable assistance to Transferee in the preparation of and filing of any IND, IND amendment, or NDA with respect to any Covered Product in the Territory, subject to Transferee’s reimbursement of Company’s Reimbursable Costs and Out-of-Pocket Expenses.

  • Secondary Objectives:• 36 month DFS and Overall Survival (OS) IND IND will be filed in the US by Galena and all trial sites will be in India Treatment NeuVax (nelipepimut_S) with [***] vs.

  • Additionally, upon Transferee’s request, Company shall make available to Transferee and/or the applicable Regulatory Authorities within the Territory all regulatory information under Company’s Control that is requested by Regulatory Authorities in the Territory in connection with their evaluation of any IND, IND amendment, or NDA for Covered Product filed by Transferee in the Territory or the Development and/or Commercialization of any Covered Product.