Study Data definition

Study Data means all data, databases, documents, reports and other information resulting from, collected or developed in the performance of the Study;

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

Study Data means the information and measurements outlined in the Study Protocol.

Examples of Study Data in a sentence

• Study Drug Sponsor grants and Protocol Sponsor shall grant each Site a limited, royalty-free non-exclusive license, with no right to sublicense, to use Study Data for non-commercial, research and educational purposes; in addition, in acknowledgement of the utilization of the clinical trial platform sponsored by the U.S. Government, Study Drug Sponsor grants to the U.S. Government a royalty-free, non-exclusive license to use Study Data for government purposes.

• The Investigator shall maintain true, correct, accurate, complete and current records of all Study Data, including the Case Report Forms (or equivalent electronic data), relevant source documents and any other essential documents or materials as required by the Protocol, the Applicable Regulatory Requirements and PSI’s and the Sponsor’s instructions (collectively the "Records").

• If the Additional Study Data is later included in the label of a CoDev Product that has received Marketing Approval anywhere in the world (whether or not such Marketing Approval is for the Non-Proposing Party’s respective Territory), the Non-Proposing Party shall reimburse the Proposing Party for [***] percent ([***]%) of the Development Costs associated with such Unsponsored Work, such amount to be deducted from any amounts owed to the Non-Proposing Party under Section 4(b) of Exhibit 1.189.

• The U.S. Government shall have the right to use, modify, reproduce, release, perform, display, or disclose Study Data within the Government and otherwise for “Unlimited rights,” as this term is defined in DFARS 252.227-7013(a)(16).

• Each Party shall have access to and the right to use, at no cost to such Party, all Additional Study Data solely as necessary to comply with safety reporting or other similar regulatory requirements in its respective Territory, but not, for example, for Marketing Approval or pricing approval.

More Definitions of Study Data

Study Data means all data, databases, documents, reports and other information resulting from, collected or developed in the performance of the Study; “Investigational product” designates the investigational product named [INSERT STUDY DRUG/DEVICE NAME], subject of the Study and described in the Protocol; {This is not applicable if there is no product involved, eg. a particular technique or treatment is being investigated}

Study Data means all data (including raw data), Case Report Forms, findings, conclusions and other results, in all cases, from the single agent arm and Combination arm of the Study and the Final Study Report, including investigator reports (both preliminary and final), statistical analyses and expert opinions and reports. Study Data excludes Sample Data.

Study Data means, with respect to a particular Study, all data (including raw data) and results (including Study Results) generated in the performance of the Study Plan for such Study and including results obtained from testing or analysis of biological samples as part of a Study pursuant to the Protocol, if applicable, and any relevant monotherapy data generated in the course of the Study pertaining to the Sponsor Product within the Study Field.

Study Data means all records and reports, other than Medical Records, collected or created pursuant to or prepared in connection with the Study including, without limitation, reports (e.g., CRFs, data summaries, interim reports and the final report) required to be delivered to Sponsor pursuant to the Protocol and all records regarding inventories and dispositions of all Investigational Product. .

Study Data has the meaning set forth in Section 3.4 hereof.

Study Data means all analyzed data, results and other data generated by any party or anyone under that party’s control in the course of performing a clinical trial or other research study in connection with a Clinical Study and includes patient records and CRFs. Study Data excludes Production Data as defined in Section 5.4(c).

Study Data means all data (including raw data), Case Report Forms, findings, conclusions and other results from the Study, including the Final Study Report. Study Data excludes the Sample Data. Study Data includes investigator reports (both preliminary and final), statistical analyses and expert opinions and reports.