IND shall definition

IND shall mean an Investigational New Drug Application filed with the FDA and any foreign counterparts thereof.
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IND shall mean an Investigational New Drug Application, as defined in the United States Code of Federal Regulations (21 CFR).
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IND shall mean an Investigational New Drug Exemption Application for the Drug Product, as defined in the United States Food and Drug Administration (FDA) rules and regulations, 21 CFR.
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Examples of IND shall in a sentence

  • The holder of the relevant IND shall be responsible for submitting adverse event reports with respect to Licensed Product in the Field to applicable Regulatory Authorities; provided that, upon Regulatory Approval, Biogen Idec shall be responsible for submitting all required adverse event reports with respect to Licensed Product to the applicable Regulatory Authorities in the Licensed Territory.

  • If the IND is not transferred to Allos within one (1) month after the Effective Date and such failure is not due to a delay by the FDA directly or indirectly caused by Licensor or Allos, such failure to timely transfer the IND shall be deemed a material breach of this Agreement, pursuant to which Allos may terminate this Agreement by providing written notice to Licensor as provided in Article 9.4(a).

  • Such transfers and disclosures shall be made (x) in any manner or form reasonably requested by Kolltan (provided, however, that any data generated since the filing of the Existing IND shall be transferred in the form in which such data exists as of the Effective Date) and (y) at MedImmune’s expense.

  • IND" shall mean an investigational new drug application filed with, and accepted by, the FDA prior to beginning clinical trials in humans in the United States, or any comparable application to and acceptance by the Regulatory Authority of a country or group of countries other than the USA thereto, including EMA, prior to beginning clinical trials in humans in that country or in that group of countries.

  • Indevus, as the holder of the IND, shall be responsible for submitting any Protocol amendments to the FDA.

  • The term "IND" shall mean an application for investigation of a new drug that has been submitted to the FDA pursuant to the Federal Food Drug and Cosmetic Act, as amended [Title 21, United States Code] and the regulations promulgated thereunder, or an equivalent application to another Regulatory Authority.

  • At the completion of the Phase I clinical trial Array shall close or inactivate the Initial IND, shall complete all relevant clinical trial and Initial IND administrative activities and shall share all clinical trial data with AZ.

  • Ciba agrees to make the following payments to Neurocrine upon the occurrence of each milestone specified below for the first Collaboration Product which meets such milestone: MILESTONES PAYMENT ---------- ------- [ * ] TOTAL OF 1-6: It is understood that an IND shall be considered "filed" when accepted by the FDA or its equivalent in another country.

  • Each Party shall have the right to review and comment on all such INDs. No IND shall be filed with any governmental or regulatory authority unless and until it has been approved by the Development Management Committee.

  • Any product which contains an Option Compound that is the subject of an Option IND shall herein be referred to as an “Option Product”.

Related to IND shall

  • shall mean the Pension Benefit Guaranty Corporation.

  • will shall be interpreted to express a command;

  • Diligent Efforts means, with respect to a Party’s obligations hereunder, the carrying out of obligations or tasks in a sustained manner consistent with the efforts a Party devotes to a research, development or marketing project for a pharmaceutical product or products of similar market potential, profit potential or strategic value resulting from its own research efforts, based on conditions then prevailing, which efforts shall in any event be no less than those which would be considered reasonable in the pharmaceutical or biotechnology industries.

  • GSK or ‘𝐺𝑆𝐾’ means the generation shift key as defined in Article 2(12) of the CACM Regulation;

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.