IND/CTA definition

IND/CTA means an Investigational New Drug / Clinical Trial Authorization application for a Product under this Agreement filed with a Regulatory Authority in a country in the Territory necessary to commence human clinical trials in conformance with Applicable Laws of such country.
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IND/CTA means(a) an Investigational New Drug application as defined in the FD&C Act and applicable regulations promulgated thereunder by the FDA or any successor application or procedure required to initiate clinical testing of a Product in humans in the Territory; and (b) all supplements and amendments to the foregoing.
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IND/CTA means (a) any Investigational New Drug Application, as defined in the United States Federal Food, Drug and Cosmetics Act, as amended from time to time, and the regulations promulgated thereunder, filed with the FDA pursuant to Part 312 of Title 21 of the U.S. Code of Federal Regulations, including any amendments thereto (an “IND”); and (b) any comparable filing(s) outside the United States (such as a CTA in the European Union) necessary to commence Clinical Trials, including any amendments thereto (a “CTA”).
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Examples of IND/CTA in a sentence

  • Without limiting the foregoing, upon the other Party’s request, and for the PCV Program if Merck exercises the Merck Participation Election for the PCV Program, in all cases prior to IND/CTA transfer, the POC Lead Regulatory Party shall provide copies of any Serious Adverse Event and applicable non-serious Adverse Event reports with respect to any Collaboration Products from such Program and any details related thereto in accordance with Section 4.3(b)(ii).

  • BioNTech shall be the sponsor and IND/CTA holder for all Clinical Trials in the Territory, in each case, subject to a mutually agreeable strategy with respect to the Development of Candidates and Products.

  • Notwithstanding the responsibilities of BioNTech as IND/CTA holder or sponsor of Clinical Trials, where Pfizer is the Lead Development Party for a Clinical Trial Pfizer shall conduct its activities in compliance with GxP and applicable Law with respect to each of the activities which have been delegated to Pfizer pursuant to Schedule 9.1.1.

  • Nightstar intends to progress the programmes through the necessary pre-clinical, IND/CTA enabling and clinical development phases necessary to achieve regulatory product licensure in the US and EU.

  • If a Regulatory Authority requests a separate IND/CTA for the Study the Parties will meet and mutually agree on an approach to address such requirement.

  • The purpose of each Research Program will be to identify, develop and evaluate Licensed ADCs and Licensed Products with respect to a Target through IND/CTA submission for further Development, Manufacture and Commercialization by ▇▇▇▇▇▇▇ in accordance with this Agreement.

  • In the event that any such IND/CTA, Drug Approval Application or Regulatory License cannot be transferred within such [...***...] period, argenx shall take all actions reasonably requested by ▇▇▇▇▇▇▇ with respect to the maintenance or transfer of such IND/CTA, Drug Approval Application or Regulatory License, and the costs thereof shall be shared by the Parties as Development Costs.

  • At the same time, argenx shall transfer to ▇▇▇▇▇▇▇ the IND/CTA for the Ongoing Phase 1/2 Clinical Study in accordance with Section 5.1.2. argenx shall continue to conduct such Clinical Study until completion of such transfer.

  • July, 2023 Complete non-GMP or GMP manufacturing and specifications – contract manufacturing of lead candidates December, 2023 Manufacturing (GMP) and Formulations – a topical (crème, patch or film) and sterile injectable formulation intravenous/subQ/i.m. March, 2024 Pre-IND Meeting with FDA on 1st MC1R candidates November, 2023 File IND/CTA for 1st MC1R lead in US/EUR with FDA/EMA March.

  • Such Loxo-Bayer Supply Agreements shall address the forecasting, ordering and delivery of Licensed Products and provide, inter alia, representations from Loxo that Licensed Products supplied thereunder have been Manufactured in accordance with Laws (including cGMP), the applicable specifications, the requirements set forth in the applicable IND/CTA, NDA/MAA and/or Marketing Authorization, and shall contain such other terms as are reasonably and customary for agreements of such type.


More Definitions of IND/CTA

IND/CTA means an Investigational New Drug Application filed with FDA or a similar application filed with an applicable Regulatory Authority outside of the ▇▇▇▇▇▇ ▇▇▇▇▇▇, [***] = CERTAIN IDENTIFIED INFORMATION HAS BEEN OMITTED FROM THIS DOCUMENT BECAUSE IT IS BOTH NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE REGISTRANT IF PUBLICLY DISCLOSED, AND HAS BEEN MARKED WITH “[***]” TO INDICATE WHERE OMISSIONS HAVE BEEN MADE. ​
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IND/CTA means a filing with a Regulatory Authority that must be made prior to commencing clinical testing in humans including (i) in the United States, an Investigational New Drug application (as defined in the FDC Act and the regulations promulgated thereunder (21 CFR 312.1 et seq)), (ii) in the European Union, a Clinical Trial Application (CTA), or (iii) in any other jurisdiction, a comparable filing and, in each case, any amendments and supplements thereto.
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Related to IND/CTA

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • Phase 3 Clinical Trial means a pivotal clinical trial in humans performed to gain evidence with statistical significance of the efficacy of a product in a target population, and to obtain expanded evidence of safety for such product that is needed to evaluate the overall benefit-risk relationship of such product, to form the basis for approval of an NDA and to provide an adequate basis for physician labeling, as described in 21 C.F.R. § 312.21(c) or the corresponding regulation in jurisdictions other than the United States.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase II Clinical Trial means a study in humans of the safety, dose ranging and efficacy of a product, which is prospectively designed to generate sufficient data (if successful) to commence a Phase III Clinical Trial or to file for accelerated approval, or otherwise consistent with the requirements of U.S. 21 C.F.R. §312.21(b) or its foreign equivalents.

  • Phase 1 Clinical Trial means, as to a specific pharmaceutical product, a Clinical Trial in humans of the safety of such product in healthy volunteers or a limited patient population, or human clinical studies directed toward understanding the mechanisms or metabolism of the product. A Phase 1 Clinical Trial shall be deemed initiated upon the dosing of the first subject or patient.