Clinical Trial Application definition

Clinical Trial Application or “CTA” means an application to a regulatory or other government agency as necessary to perform human clinical trials in conformance with Applicable Laws.

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Clinical Trial Application means a submission made to the applicable Innovate Regulatory Agency or Company Regulatory Agency, the purpose of which is to gain necessary clearance, licensure, or approval by such agency to lawfully distribute a product to perform a human clinical trial of such product that at the time of such submission is not otherwise lawfully able to be distributed or marketed in interstate commerce under the laws of the relevant jurisdiction.

Clinical Trial Application means an application to carry out a Clinical Trial.

Examples of Clinical Trial Application in a sentence

If necessary the parties shall take all necessary measures with a view to having the present patent licence agreement registered with the competent national or international administrations.
Except to the extent otherwise required by relevant regulatory agencies or other governmental entities, there shall be one Clinical Trial Application in each country for all clinical trials for each distinct Licensed Product.
No Clinical Trial Application filed by or on behalf of Elan with the FDA regarding any Alpha-4 Integrin Product or JCV Assay has been terminated or suspended by the FDA, and the FDA has not commenced, or, to the knowledge of Elan, threatened in writing to initiate, any action to place a clinical hold order on, or otherwise terminate or suspend, any ongoing clinical investigation conducted by or on behalf of Elan involving any Alpha-4 Integrin Product or JCV Assay.
Licensee shall use commercially reasonable efforts to offer DKFZ and/or University of Tübingen an opportunity to act as clinical trial sites in each clinical trial of a Licensed Product that will be conducted under a Clinical Trial Application (“CTA”) in the European Union.
Cellectis shall prepare, file and prosecute all regulatory applications useful or necessary to obtain approvals at Cellectis name to develop the Candidate Product up to Phase 1 (e.g. Clinical Trial Application or equivalent), based on the Development Plan as previously agreed by the JSC.

More Definitions of Clinical Trial Application

Clinical Trial Application or “CTA” has the meaning accorded this term in accordance with the requirements of Health Canada, including all amendments and supplements to such application, or any IND or other equivalent filing with any other Regulatory Authority.

Clinical Trial Application means an effective Notice of a Claimed Investigational New Drug Exemption, as defined in Title 21 of the Code of Federal Regulations, on file with the FDA before the commencement of clinical trials of Licensed Products in humans, or any comparable filing with any relevant regulatory agencies or other governmental entities in any country in the Territory.

Clinical Trial Application or “CTA” has the meaning set forth in Section 1.76 (“IND”).

Clinical Trial Application means a document used to request authorization from a Regulatory Authority to begin testing an experimental compound/drug in patients.

Clinical Trial Application means an Investigational New Drug Application for any Product filed with the FDA pursuant to Title 21 of the Code of Federal Regulations, Part 312 (“IND”) or the submission to a competent Regulatory Authority within the EU of a request for an authorization concerning a clinical trial, as envisaged in Article 9, paragraph 2, of Directive 2001/20/EC, or any comparable filing made with a Regulatory Authority in another country or territory other than the U.S. or the EU.

Clinical Trial Application means any and all applications to the European Medicines Agency or other appropriate Regulatory Health Authorities for the permission to perform a clinical study as required by Applicable Law.

Clinical Trial Application means any application or submission to any Regulatory Agency for authorization to conduct a Clinical Trial of any Included Product in any country or group of countries. “Clinical Updates” means, with respect to each ongoing or proposed Clinical Trial, a summary of (a) the current status of enrollment, (b) the estimated completion date, (c) the status of any clinical hold imposed, or threatened to be imposed, by any Regulatory Agency, (d) any unexpected fatal or life-threatening suspected adverse reaction, as that term is defined in 21 CFR 312.32 (or comparable regulations under other Applicable Law), and (e) any other material information and developments with respect to such Clinical Trial, including any change or modification to or termination of such Clinical Trial. “Closing Date” means May 12, 2023. “Code” means the Internal Revenue Code of 1986, as amended from time to time. “Collateral” has the meaning set forth in the Security Agreement. “Commercial Updates” means material information and developments with respect to the Obligors’ Commercialization plans and prospects for the Included Products. “Commercialization” means any and all activities, other than manufacturing, directed to the preparation for sale of, or sale of the Included Products, including activities related to marketing, promoting, distributing, and importing the Included Products, and interacting with Regulatory Agencies regarding any of the foregoing. When used as a verb, “to Commercialize” and “Commercializing” means to engage in Commercialization, and “Commercialized” has a corresponding meaning. “Common Stock” means Parent’s common stock, par value $0.0001 per share. “Company” has the meaning set forth in the first paragraph hereof. “Competitor” means, at any time of determination, any Person (and each other Person that owns or controls, directly or indirectly, such Person, or that controls or is controlled by or is under common control with such Person) that is an operating company and that directly and primarily engaged in the same, substantially the same, or similar line of business as the Company and its Subsidiaries, taken as a whole, as of such time. As used in this definition, “control” means (a) direct or indirect beneficial ownership of at least fifty percent (50%) (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) of the voting share capital or other equity interest in a Person or (b) the power to di...