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).
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.