Final Study Report. Corvus shall complete the Study as outlined in the Protocol. Corvus shall summarize the findings of the Study in a Final Study Report. Corvus shall provide the Final Study Report to Genentech within [***] after Database Lock. “Final Study Report” means a formal clinical study report documenting and summarizing the results and interpretation of the Study, including the trial design, trial objectives, patient assessment, data analysis, results, risk/benefit analysis, safety and effectiveness, in accordance with the requirements of then-existing Regulatory Authority rules, regulations and guidance on the structure and content of clinical study reports.
Final Study Report. Company shall provide Merck with an electronic draft of the final study report promptly following Study Completion, and Merck shall have [*****] days after receipt of such draft to provide comments thereon. Company shall consider in good faith any comments provided by Merck on the draft final study report and shall not include any statements relating to the Merck Compound that have not been approved by Merck. Company shall deliver to Merck a final version of the final study report promptly following finalization thereof (the “Final Study Report”). “Study Completion” shall occur upon database lock of the Study results.
Final Study Report. BioLineRx shall provide Merck with (i) an electronic draft of the final Study report, for Merck to provide comments to BioLineRx within [*] days of receipt of the draft of the final Study report and (ii) a final version of the final Study report (the “Final Study Report”) promptly following Study Completion. BioLineRx shall consider in good faith any comments provided by Merck on the draft of the final Study report and shall not include any statements relating to the Merck Compound [*]. “Study Completion” shall occur upon database lock of the Study results.
Final Study Report. Syndax shall use its best efforts to complete the Study as outlined in the Protocol. Syndax shall summarize the findings of the Study in a Final Study Report. Syndax shall provide the Final Study Report to Genentech within six (6) months after Database Lock. “Final Study Report” means a formal clinical study report documenting and summarizing the results and interpretation of the Study, including the trial design, trial objectives, patient assessment, data analysis, results, risk/benefit analysis, safety and effectiveness.
Final Study Report. The final study report will include all available efficacy, immunogenicity (including exploratory analyses) and safety data; clinical assessments; and concomitant medications from the duration of the study. Modifications or additions to the analyses described in Section 7.2 to Section 7.5 will be included in the SAP. Any decisions to deviate from the planned analyses described in the protocol and in the statistical analysis plan will be described in detail in the final study report.
Final Study Report. Adaptimmune shall provide Merck with an electronic draft of the final study report promptly following Study Completion, and Merck shall have *** days after receipt of such draft to provide comments thereon. Adaptimmune shall consider in good faith any comments provided by Merck on the draft final study report and shall not include any statements relating to the Merck Compound that have not been approved by Merck. Adaptimmune shall deliver to Merck a final version of the final study report promptly following finalization thereof (the “Final Study Report”). “Study Completion” shall occur upon database lock of the Study results.
Final Study Report. I will notify the IRB upon completion of the research study and submit a final study report.
Final Study Report. BIOCLINICA will prepare a study report, which will include: • Protocol Overview • Project Summary • Summary of Subject Assessments • Receipt and Preparation of Image Data for Image Review • Description of the image review application • Image Interpretation Training Session and Reader Training/Qualification • Image Interpretation Sessions • Transfer of Data to VASCULAR BIOGENICS Appendices may include the following documents: • Imaging Charter • Listing of Image Data Received • Business Requirements Specification Document • Applicable Note to File(s) • Curriculum Vitae of Radiologists and Designated Experts • Read Rules Document • Image Review Monitoring Plan • Listing of Subjects Read • Data Export Specifications Document *Please note the Final Study Report does not include a statistical analysis of the data. BIOCLINICA shall deliver the study report to VASCULAR BIOGENICS within thirty (30) business days following completion of the final data transfer. VASCULAR BIOGENICS will have a review period of thirty (30) business days, following delivery of the report. Within this period, VASCULAR BIOGENICS may request within-scope revisions to the report and BIOCLINICA will make requested within-scope revisions at no additional cost to VASCULAR BIOGENICS. Portions of this exhibit have been omitted and filed separately with the SEC pursuant to a confidential treatment request and are indicated by [***]. Vascular Biogenics Ltd. Ulcerative Colitis Study
Final Study Report. FLX shall provide Merck with an electronic draft of the final Study report promptly following Study Completion, and Merck shall have [***] days after receipt of such draft to provide comments thereon. FLX shall consider in good faith any comments provided by Merck on the draft final Study report and shall not include any statements therein relating to the Merck Compound that have not been approved by Merck. FLX shall deliver to Merck a final version of the final Study report promptly following finalization thereof (the “Final Study Report”).
Final Study Report. Antigen Express shall provide Merck with an electronic draft of the final study report promptly following Study Completion, and Merck shall have thirty (30) days after receipt of such draft to provide comments thereon. Antigen Express shall reasonably consider any comments provided by Merck on the draft final study report and shall not include any statements relating to the Merck Compound that have not been approved by Merck. Antigen Express shall deliver to Merck a final version of the final study report promptly following finalization thereof (the “Final Study Report”). “Study Completion” shall occur upon database lock of the Study results.
