Data Lock definition

Data Lock means, with respect to a Proprietary Product, the locking by or on behalf of Licensor of the database of the [***] in order to prevent or control any further changes to such data after review, query resolution and reasonable determination by Licensor (in accordance with industry standards) that such database is ready for analysis; provided that Data Lock shall be deemed to have occurred upon the [***] is still ongoing at such time.” 1.5 The following provision shall be inserted into the License Agreement as new Section 1.28A:

Data Lock means, with respect to a Clinical Trial being conducted by or on behalf of Prothena (or by or on behalf of Celgene with respect to a Phase 1 Clinical Trial if it exercises the Celgene Phase 1 Portion Participation Right) for a Development Candidate under the Collaboration, the locking by or on behalf of Prothena (or by or on behalf of Celgene with respect to a Phase 1 Clinical Trial if it exercises the Celgene Phase 1 Portion Participation Right) of the database that contains the data for such Clinical Trial following completion of such Clinical Trial in order to prevent or control any further changes to such data after review, query resolution and reasonable determination by Prothena (or Celgene, if applicable) (in accordance with industry standards) that such database is ready for analysis.

Data Lock means, with respect to a Clinical Trial being conducted by or on behalf of Prothena (or by or on behalf of Celgene with respect to a Phase 1 Clinical Trial if it exercises the Xxxxxxx Xxxxx 0 Portion Participation Right) for a Development Candidate under the Collaboration, the locking by or on behalf of Prothena (or by or on behalf of Celgene with respect to a Phase 1 Clinical Trial if it exercises the Xxxxxxx Xxxxx 0 Portion Participation Right) of the database that contains the data for such Clinical Trial following completion of such Clinical Trial in order to prevent or control any further changes to such data after review, query resolution and reasonable determination by Prothena (or Celgene, if applicable) (in accordance with industry standards) that such database is ready for analysis.

Examples of Data Lock in a sentence

• In the event of a Shelf Registration, the Company shall bear or reimburse the Holders of the Securities covered thereby for an amount not to exceed $25,000 for the reasonable fees and disbursements of one firm of counsel designated by the Holders of a majority in principal amount of the Initial Securities and the Accredited Investor Securities covered thereby to act as counsel for the Holders of the Initial Securities and the Accredited Investor Securities in connection therewith.

• Remote SDV should at this point only be required for a few clinical trials: • Clinical trials investigating treatment and prevention of COVID-19• Pivotal clinical trials soon reaching Data Lock Point and thereby trial com- pletion, analysis and reporting of trial data.Implementation of remote access must be carried out in close collaboration with the site investigators.

• If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program.

• As soon as possible, but in all cases within [***] ([***]) months after Data Lock for the applicable Clinical Trial, Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the final study report for the Phase 1 Clinical Trial for such Program (which shall be prepared in accordance with customary practice that meets the standards of ICH Topic E3 of ICH Guidelines for Structure and Content of Clinical Study Reports dated July 1996).

• An equality impact assessment must be completed by the manager on the proposed changes to the establishment structure.

More Definitions of Data Lock

Data Lock means, with respect to a Phase 1 Clinical Trial or any Phase 1a Clinical Trial being conducted by Jounce for a Collaboration Candidate under the Collaboration, the locking by or on behalf of Jounce of the database that contains the data for such Phase 1 Clinical Trial in a manner to prevent or control any further changes to such data after review, query resolution and reasonable determination by Jounce (in accordance with industry standards) that such database is ready for analysis.

Data Lock means, with respect to a Clinical Trial being conducted by or on behalf of a Person, the locking (no additional data collected and no data is removed) by or on behalf of such Person of the database that contains the data collected from such Clinical Trial in a manner consistent with industry standards and Laws to enable data analysis and reporting of such Clinical Trial.

Data Lock means, with respect to the PRX019 Phase 1 Clinical Trial being conducted by or on behalf of Prothena (or by or on behalf of Celgene if Celgene exercises the Celgene Phase 1 Portion Participation Right), the locking by or on behalf of Prothena (or by or on behalf of Celgene if Celgene exercises the Celgene Phase 1 Portion Participation Right) of the database that contains the data for the PRX019 Phase 1 Clinical Trial following completion of the collection of the clinical data arising from the PRX019 Phase 1 Clinical Trial in order to prevent or control any further changes to such data after review, query resolution and reasonable determination by Prothena (or Celgene, if applicable) [***] that such database is ready for analysis.

Data Lock means, with respect to a Clinical Study being conducted by or on behalf of a Party, the locking by or on behalf of such Party of the database that contains the data collected from such Clinical Study in a manner consistent with industry standards to enable data analysis and reporting.

Data Lock means, [†]. Notwithstanding the foregoing sentence, if primary endpoint or safety data for such Phase II Clinical Trial is publically disclosed, Data Lock will be deemed to have occurred with respect to such Clinical Trial.

Data Lock means, in respect of a clinical trial in support of a new drug application, the time at which, in accordance with the trial protocol, no modifications will be made to the clinical trial data base.

Data Lock means, with respect to a Phase I Clinical Trial being conducted by or on behalf of any Party or any of its Affiliates for a ROFN Asset, [***].