Non-Clinical Data definition

Non-Clinical Data means all data and results (other than Clinical Data) for a product (including such data and results for an active agent therein), including biological, chemical, pharmacological, pharmacokinetic, toxicological, pharmaceutical, physical and analytical, pre-clinical, safety, manufacturing, stability, and quality-control data, in each case submitted to a Regulatory Authority in any IND, application for Clinical Studies or Regulatory Approvals (including any Drug Approval Application).
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Examples of Non-Clinical Data in a sentence

  • For clarity, Clinical Data and Non-Clinical Data generated in connection with this Agreement, and Regulatory Documentation and the identity of Collaboration Targets and Product Forms hereunder, shall be considered Confidential Information of BMS, except to the extent that ATI may use such Non-Clinical Data for Patents purposes pursuant to Section 14.1(d)(ii).

  • For clarity, BMS’ licenses to Know-How, Materials, Clinical Data, Non-Clinical Data, Patents or other intellectual property rights that were Controlled by ATI or any of its Affiliates prior to a Change of Control of ATI shall remain in full force and effect subsequent to any such Change of Control of ATI.

Related to Non-Clinical Data

  • Clinical Data means the information with respect to the Licensed Product or the Licensed Compound made, collected or otherwise generated under or in connection with pre-clinical, clinical, or the post-Approval studies for the Licensed Compound or Licensed Product, including any data, reports and results with respect to any of the foregoing.

  • Manufacturing Technology means any and all patents, patent applications, Know-How, and all intellectual property rights associated therewith, and including all tangible embodiments thereof, that are necessary or useful for the manufacture of adeno- associated viruses, adeno-associated virus vectors, research or commercial reagents related thereto, Licensed Products, or other products, including manufacturing processes, technical information relating to the methods of manufacture, protocols, standard operating procedures, batch records, assays, formulations, quality control data, specifications, scale up, any and all improvements, modifications, and changes thereto, and any and all activities associated with such manufacture. Any and all chemistry, manufacturing, and controls (CMC), drug master files (DMFs), or similar materials provided to regulatory authorities and the information contained therein are deemed Manufacturing Technology.

  • Participating Clinical Laboratory means a Clinical Laboratory which has a written agreement with the Claim Administrator or another Blue Cross and/or Blue Shield Plan to provide services to you at the time services are rendered.

  • Technical Data means recorded information, regardless of the form or method of the recording, of a scientific or technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information.

  • Collaboration Technology means all Collaboration Patents and Collaboration Know-How.