IND Holder definition

IND Holder means the person or organization filing an IND with the FDA. The IND Holder agrees to comply with all FDA regulations and obligations relevant to experimental clinical trials (synonymous with the term “sponsor”. The IND holder for purposes of this agreement is the Collaborator.
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IND Holder is defined as: A "Sponsor" as defined in 21 CFR Part 313.1(b) of an investigational new drug in any regulatory jurisdiction, including a holder of a foreign equivalent thereto.
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Examples of IND Holder in a sentence

  • When all appropriate review and approval has occurred the IND Holder shall submit the protocol to the FDA.

  • To achieve these objectives, The Research Organisation and ▇▇▇▇▇ agree to perform the following study-related activities Scope of Work by Party: • St. Jude Children’s Research Hospital (the Research Organization): • IND Holder and Study Sponsor • Regulatory Preparation, Submissions, and Reporting per Guidelines.

  • IND Holder is defined as: A “Sponsor” as defined in 21 C.F.R. Section 312.3(b) of an investigational new drug in any regulatory jurisdiction, including a holder of a foreign equivalent thereto.

Related to IND Holder

  • Demand Holder has the meaning set forth in Section 3.02(a).

  • Preferred Holder means each of the Preferred Shareholders and its permitted assignees to whom its rights under this Section 4 have been duly assigned in accordance with this Agreement; “Restricted Shares” means any of the Company’s securities now owned or subsequently acquired by an Ordinary Holder;

  • FTR Holder means the PJM Member that has acquired and possesses an FTR.

  • Deceased Holder Not applicable.

  • Series B Holder means a Record Holder of the Series B Preferred Units.