IND definition

IND means an Investigational New Drug application, Clinical Study Application, Clinical Trial Exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

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IND means (a) an Investigational New Drug Application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA, or (b) the equivalent application to the applicable Regulatory Authority in any other regulatory jurisdiction, the filing of which is necessary to initiate or conduct clinical testing of a pharmaceutical product in humans in such jurisdiction.

IND means an Investigational New Drug Application submitted to the FDA in conformance with applicable laws and regulations, or the foreign equivalent of any such application in any other country.

Examples of IND in a sentence

• As between the Parties, ▇▇▇▇▇ shall have sole responsibility for and control of the preparation, submission, and maintenance of all Regulatory Filings and obtaining Regulatory Approvals (including the preparation and submission of the IND filing and for seeking IND approval) with respect to Licensed Compounds and Licensed Products, and shall have sole control over all interactions with the applicable Regulatory Authority, in each case, at its sole cost and expense.

• Notwithstanding the foregoing, on a Research Program-by-Research Program basis, should ▇▇▇▇▇ take over the performance of a Research Plan in its entirety pursuant to Section 4.6, and the JRC has been disbanded pursuant to Section 2.7, ▇▇▇▇▇ shall [***] notify Aktis in writing upon a Licensed Compound becoming an IND Candidate with respect to such Research Program, which notice shall include the date on which such Licensed Compound became an IND Candidate hereunder.

• Following the end of each applicable Research Term, as between the Parties, ▇▇▇▇▇ shall have the sole right to conduct, and be solely responsible for, as between the Parties, at its sole cost, the Exploitation of all Licensed Compounds and Licensed Products arising from such Research Program, including for preparation and submission of any applicable IND filing and any other Regulatory Filings.

• In the event that the JRC determines that a Licensed Compound has achieved the TPP Criteria, then (a) such event shall be recorded in the minutes of the JRC and (b) such Licensed Compound shall be deemed an IND Candidate.

• Each Research Plan will include activities designed to accomplish the following: discovery, selection and optimization of Licensed Compounds; selection of one or more Lead Candidates; and selection of an IND Candidate; in each case, in a manner consistent with Exhibit 4.1.

More Definitions of IND

IND means an Investigational New Drug Application (as defined in the Food, Drug and Cosmetic Act, as amended) filed with the FDA or its foreign counterparts.

IND means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application in the EU).

IND means any Investigational New Drug Application filed or to be filed with the FDA as described in Title 21 of the U.S. Code of Federal Regulations, Part 312, and the equivalent application in the jurisdictions outside the United States, including an “Investigational Medicinal Product Dossier” filed or to be filed with Regulatory Authorities in the European Union.

IND means an investigational new drug application filed with the United States Food and Drug Administration prior to beginning clinical trials in humans in the United States or any comparable application filed with regulatory authorities in or for a country or group of countries other than the United States.

IND means an investigational new drug application filed with the FDA for authorization to commence Clinical Studies in the United States (including all additions, supplements, extensions and modifications thereto), or any corresponding foreign application in the Territory.

IND. IND means an investigational new drug application filed with the FDA with respect to a Product, or an equivalent application filed with the Regulatory Authority of a country other than the US.

IND means (a) an Investigational New Drug Application filed with the FDA or its equivalent in any country outside the United States where a regulatory filing is required or obtained to conduct a clinical trial; or (b) with respect to any country where a regulatory filing is not required or obtained to conduct a clinical trial, the first enrollment of a patient in the first trial involving the first use of a Licensed Product in humans.