NDA Data definition

NDA Data means the existing readily available dossiers in TXMD’s or the TXMD Group’s possession as of the Closing Date containing the Know-How actually used by TXMD and/or the TXMD Group to obtain and maintain the Product NDAs in the Territory.
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NDA Data means the existing readily available dossiers in Novartis’ possession as of the Closing Date containing the Know-How actually used by Novartis and/or its Affiliates to obtain and maintain the Product NDAs in the Territory.
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NDA Data means the existing readily available dossiers or copies thereof in Seller’s or its subsidiaries or controlled Affiliates’ possession as of the Closing Date containing any information actually used or submitted by Seller or any of its subsidiaries or controlled Affiliates to obtain and maintain the Product INDs and the Product NDAs in the Territory.
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Examples of NDA Data in a sentence

  • Data Submissions and Judging As discussed earlier, registered teams must provide confidential (under NDA) Data Submissions for Design Judging on a Pass/Fail basis (with one opportunity for appeal) in these areas: • Safety, Emissions• Manufacturability, Cost• Features• Business PlanVehicle designs that passed Design Judging were invited to move on to the next stage of the Progressive Insurance Automotive X PRIZE, and were announced to the public on 19 October 2009.

  • In addition, upon Palatin submitting a U.S. NDA Data Package to the FDA, Palatin shall provide the U.S. NDA Data Package to Xxxxxx Xxxxxxx within *** after the U.S. NDA submission, which is anticipated to be no later than ***.

  • To request access of the data, researchers will use the standard processes at NDA, and the NDA Data Access Committee will decide which requests to grant.

  • Initial focus on service and clinical questions to support SAGE e.g. indirect effects of COVID-19 on cancer outcomes and screening programmes.National Diabetes Audit (NDA) (Data Analysis)• Linking NDA data with intensive care data – supports urgent research request to investigate potential associations / specific risk factors for diabetic patients.

  • AMP SCZ investigators, AMP SCZ partners, FNIH and NIH staff will have access to the data in the NIMH NDA Collaboration Space for monitoring and data analysis purposes (subject to execution of an NDA Data Access Agreement).

  • They are also critical to understanding the impact of supports on the lives of people with disability.NDS is pleased to see the recommendation in the Productivity Commission’s latest report on the National Disability Agreement (NDA) for the development of an NDA Data Strategy for collecting, funding and reporting data.

  • MMRM versus MI in Dealing with Missing Data – A Comparison Based on 25 NDA Data Sets, Journal of Biopharmaceutical Statistics, 21: 423–436, 2011.

  • Licensed educators in violation of the NDA, Data Governance Plan, or USBE Board Rule R277-487 may be subject to disciplinary action by the school or by the Utah State Board of Education.Data DisclosuresAll disclosures of student data must be done in accordance with the Family Educational Rights and Privacy Act (FERPA) and the Utah Student Data Protection Act.A. Written Parental ConsentData may be disclosed to any party and in any case where the parent or adult student provides written parental consent.

  • MMRM versus MI in Dealing with Missing Data—A Comparison Based on 25 NDA Data Sets, J of Biopharm Statist.

  • No later than [**] prior to the NDA Transfer Date, Seller shall deliver the NDA Data to Buyer.

Related to NDA Data

  • Study Data shall have the meaning set forth in Section 8.1.

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • Licensed Data means the data licensed by the LME to the Licensee set out in the Order Form and further defined in Schedule 1 (Licensed Data);

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Research Data means documents in a digital form, other than scientific publications, which are collected or produced in the course of scientific research activities and are used as evidence in the research process, or are commonly accepted in the research community as necessary to validate research findings and results;

  • GLO Data means any data or information owned by the GLO, including PII or SPI as defined below, that Provider creates, obtains, accesses (via records, systems, or otherwise), receives (from the GLO or on behalf of the GLO), or uses in the performance of the Contract or any documents related thereto.

  • Licensee Data means, other than Resultant Data, information, data and other content, in any form or medium, that is collected, downloaded or otherwise received, directly or indirectly from Licensee or an Authorized User by or through the Services.

  • UNICEF Data means any and all information or data in digital form or processed or held in digital form that

  • Development Data means all non-clinical, clinical, technical, chemical, safety, and scientific data and information and other results, including relevant laboratory notebook information, screening data, and synthesis schemes, including descriptions in any form, data and other information, in each case, that is generated by or resulting from or in connection with the conduct of Development of Products.

  • Raw Data means the primary quantitative and empirical data first collected from experiments and clinical trials conducted within the scope of this CRADA.

  • Licensed Materials means any materials that Executive utilizes for the benefit of the Company (or any Subsidiary thereof), or delivers to the Company or the Company’s Customers, which (a) do not constitute Work Product, (b) are created by Executive or of which Executive is otherwise in lawful possession and (c) Executive may lawfully utilize for the benefit of, or distribute to, the Company or the Company’s Customers.

  • User Data means any Personal Data or other data or information collected by or on behalf of the Company or any of its Subsidiaries from users of any Company Product or website of the Company or any of its Subsidiaries.

  • Customer Data means any content, materials, data and information that Authorized Users enter into the production system of a Cloud Service or that Customer derives from its use of and stores in the Cloud Service (e.g. Customer-specific reports). Customer Data and its derivatives will not include SAP’s Confidential Information.

  • System Data means data and data elements collected by the SaaS Software, SaaS Service or Licensor’s computer systems regarding configuration, environment, usage, performance, vulnerabilities and security of the SaaS Software or SaaS Service that may be used to generate logs, statistics and reports regarding performance, availability, integrity and security of the SaaS Software.

  • Product Information has the meaning specified in Section 10.12(a).

  • Third Party Materials means materials and information, in any form or medium, including any software, documents, data, content, specifications, products, equipment or components of or relating to the Services that are not proprietary to NCIT.

  • Client Data means all data or records of whatever nature in whatever form relating to the Client, its operations, facilities, assets, employees, students or otherwise relating to its business, whether subsisting at the date of this Agreement, or created or processed in connection with the Services or as provided by the Client to the Supplier in connection with the Services. Client Data shall include all Client Personal Data

  • SAP Materials means any materials (including statistical reports) provided, developed or made available by SAP (independently or with Customer’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Professional Services to Customer. SAP Materials do not include the Customer Data, Customer Confidential Information or the Cloud Service. SAP Materials may also be referred to in the Agreement as “Cloud Materials”.

  • input data means data provided to or directly acquired by an AI system on the basis of which the system produces an output;

  • Vendor Data means any and all information, data and documentation to be provided by Subcontractor and any of its lower-tier Subcontractors under this Subcontract.

  • Clinical Data means the information concerning the safety or performance that is generated from the use of a device and that are sourced from the following:

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • End User Data means any information or data of any kind that personally identifies (or that can be used, together with other information or data, to personally identify) an End User.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Patient Data means any electronic data, information or material about a Patient entered into the Software.

  • APIs means SAP application programming interface and accompanying or related Documentation, source code, tools, executable applications, libraries, subroutines, widgets and other materials made available by SAP or through SAP tools or SAP Software Development Kit (and all derivative works or modifications thereof) to Provider that allow Provider to integrate the Provider Service with the Cloud Service, including any access code, authentication keys or similar mechanisms to enable access of the APIs.