NDA/CDA definition

NDA/CDA means the NDA and the CDA.
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Examples of NDA/CDA in a sentence

  • This Agreement constitutes the entire agreement between the Parties with respect to the subject matter hereof and supersedes all prior agreements (excluding the VOLCANO Agreement and the NDA/CDA), understandings, negotiations and discussions, whether written or oral; for purposes of construction, this Agreement will be deemed to have been drafted by both Parties.

  • The AVL, B▇▇▇ of Material, Forecasts, Orders, Product Requirements and other information identified in this Agreement as VOLCANO confidential must be held in confidence by EI under the terms of the NDA/CDA.

  • The Parties will be bound by the terms of the NDA and/or the CDA and any information designated as Confidential under this Section 14.1 shall also be considered “Proprietary Information” as such term is defined in the NDA/CDA.

  • To the extent any term of this Agreement conflicts with any term in the NDA/CDA, the terms of this Agreement will control and take precedence.

  • VOLCANO agrees to maintain the confidentiality of EI’s Technical Manufacturing Information under the terms specified in Section 14 below and in accordance with the terms and conditions of the NDA/CDA.

  • EI agrees to maintain the confidentiality of the Product Requirements under the terms specified in Section 14 below and in accordance with the terms and conditions of the NDA/CDA.

  • Proprietary Information, as defined in the NDA/CDA, may only be used by those employees or temporary employees of the Recipient who have a need to know such information for purposes related to this Agreement.

  • A non-disclosure/confidentiality agreement (NDA/CDA) is often sent by the Grant Coordinator, to participating sites on behalf of a NSHA investigator for review, approval and signature in advance of sending the protocol site agreement and budget (if required for IIR research at NSHA) or an NDA/CDA is received directly by the Investigator or Contracts/Grants Office and is reviewed, approved by the Grant Coordinator and signed in advance of receiving/sending the protocol, site agreement and budget.

  • Confidentiality clause of the Collaboration agreement will supersede such NDA/CDA unless parties agree in the Collaboration Agreement that their confidentiality obligations will remain to be governed by the concluded NDA/CDA (less likely option).

  • Non-DisclosureConfidentiality Agreements NDACDA are legal documents.

Related to NDA/CDA

  • NDA means a New Drug Application, as defined in the United States Federal Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or similar application filed with an equivalent regulatory body in another country.

  • ANDA means an Abbreviated New Drug Application, or similar application for marketing approval of a Product submitted to the FDA.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Novartis shall have the meaning set forth in the Preamble.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.