Data Lock definition
Examples of Data Lock in a sentence
Licensor shall, within [***] of the end of each calendar quarter starting on the commencement of [***] for such Proprietary Product and ending on Data Lock with respect to such Proprietary Product, provide to Licensee a summary with respect to any material [***] activities (including any [***]) undertaken by or on behalf of Licensor with respect to such Proprietary Product, including a summary of the results and data generated from such activities (each a “Study Summary”).
Upon Data Lock with respect to any Proprietary Product, Licensor shall promptly provide to Licensee a written notice of such Data Lock and a final Study Summary for such Proprietary Product to the extent any such activities, results or data up to Data Lock has not previously been covered in a Study Summary already provided to Licensee.
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).
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.
CMS shall request the PSUR from NORGINE at least SEVENTY (70) Days in advance of the Data Lock Point (“DLP”).