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.”

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

• The Authority will accept a single harmonized IBD and Data Lock Point (DLP) for each product in order to reduce the burden of work in preparing PSURs/PBRERs for different regulatory authorities.In situations where an MAH is preparing PSURs/PBRERs on annual basis or longer period for different regulatory authorities based on the IBD and the Authority requires a six-month cycle based on the LBD, the most recent PSUR/PBRER with a longer time frame will be acceptable to the Authority.

• 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.

• Generally, each PSUR and PBRER should cover the period of time since the last PSUR/PBRER and should be submitted within 60 days after the Data Lock Point.

• Periodic Safety Update Report (PSUR) The applicant has applied for a PSUR submission scheme of 3 years upon approval as ribavirin is found in the list published by the Heads of Medicines Agencies with an EU Harmonised Birthday and related Data Lock Point (DLP).

• 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.

More Definitions of Data Lock

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 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 Company for a Collaboration Candidate under the Collaboration, the locking by or on behalf of Company 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 Company (in accordance with industry standards) 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 your

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, [***].

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.