IND Application definition

IND Application means investigational new drug application filed with the U.S. Food and Drug Administration or any successor application thereto and any foreign equivalent of any such application filed with the applicable regulatory authority.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedBook a Demo

IND Application has the meaning provided in Section 9.2.1.

IND Application means an application submitted to a Competent Authority for authorization by the applicable Competent Authority to initiate human clinical trials, including an (i) Investigational New Drug application filed with the US Food and Drug Administration in the United States, (ii) a clinical trial application submitted to the European Medicines Agency of the European Union, (iii) a clinical trial application submitted to the National Medical Products Administration (NMPA) of China, and (iv) any equivalent filing in any other jurisdiction.

Examples of IND Application in a sentence

• The IND Application will be in material compliance with applicable laws and rules and regulations when filed.

• Following submission of a new IND application [**] (“New IND Application”), Telix shall make a one-time payment to Wilex of US$[**] within [**] after receiving approval by the FDA (or equivalent regulatory body) of the New IND Application.

• Following submission of a new IND application either comprising of: (“New IND Application”) Telix shall make a one-time payment to Wilex of US$[**] within [**] after receiving approval or of a corresponding confirmation by the FDA (or equivalent regulatory body) of the New IND Application.

• Approved Investigator will submit an IND Application to the FDA to conduct the Formulary Protocol in accordance with obligations of 21 CFR Part 312, and will be responsible for all regulatory submissions to the FDA concerning the Formulary Protocol.

• LICENSEE or its Affiliate shall further transfer free of charge to MTPC or its nominee any IND, Application or other documents filed with any government agency in LICENSEE Territory and any Registration obtained in LICENSEE Territory LICENSEE shall, at the request of MTPC, cooperate with MTPC or its nominee for the smooth transfer of them.

• The NHLBI acknowledges that the Company has provided the IND Sponsor with a letter of cross-reference to all pertinent regulatory filings (including IND 13335) sponsored by the Company for the limited purpose of IND Application 13967.

• LICENSEE or its Affiliate shall further transfer free of charge to MPC or its nominee any IND, Application or other documents filed with any government agency in LICENSEE Territory and any Registration obtained in LICENSEE Territory.

• Accordingly, NHLBI and the IND Sponsor hereby grant Company a right to cross-reference relevant data within IND Application 13967 for purposes of developing and commercializing Company’s products, including without limitation the Test Article.

• AGIX, its Affiliate or a third party selected by AGIX will be solely responsible for the selection and testing of Licensed Products that it schedules to advance into IND Application in the U.S., or equivalent development programs throughout the world.

• Disbursements and/or Loan proceeds disbursed under this Agreement and/or the Loan Documents shall be used solely to pay Contract Research Organization IQVIA to perform clinical research services with respect to that certain clinical trial known as “A Randomized, Controlled, Multi-Center Study of OT-I 01 in COVID-19 Patients (Investigational New Drug (IND) Application #149299)” (the “Clinical Trial”), and for no other purpose.

More Definitions of IND Application

IND Application means an application for approval of a request for authorization by the U.S. Food and Drug Administration or similar authority in the jurisdiction to administer an IND to humans.

IND Application or “IND” means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, including any amendments or supplements thereto, or (b) the equivalent application to a Regulatory Authority in any other regulatory jurisdiction, which must be in effect to initiate or conduct clinical testing of a pharmaceutical or biological product in humans in such jurisdiction, including any amendments or supplements thereto.

IND Application means an Investigational New Drug Application filed with the United States Food & Drug Administration prior to administration of a pharmaceutical product to humans.