Inspection Findings and Responses. Principal Investigator and Institution will promptly forward to CRO and Pfizer copies of any inspection findings that either receives from a regulatory authority in relation to the Study. Whenever feasible and permitted by law, Principal Investigator and Institution will also provide CRO and Pfizer with an opportunity to prospectively review and comment on any responses to regulatory authority inspections in regard to the Study.
Inspection Findings and Responses. AMC will promptly forward to Pfizer copies of any inspection findings (e.g. Establishment Inspection Report, FDA Form 483 or USDA Inspection Report) that it receives from any regulatory agency in relation to the Program. Whenever feasible, AMC will also provide Pfizer with an opportunity to prospectively review and comment on AMC’s responses to regulatory agency inspections in regard to the Program.
Inspection Findings and Responses. Within five (5) Business Days of receipt, ArcherDX will forward to MRK copies of any inspection findings in any way related to the Activities that ArcherDX receives from a Regulatory Authority during the Term.
Inspection Findings and Responses. The Health Services Provider will promptly forward to CRO and Pfizer, or confirm that Principal Investigator has done so, copies of any inspection findings that the Health Services Provider receives from a regulatory authority in relation to the Study. The Health Services Provider will also cooperate with Pfizer as needed to help ensure that Principal Investigator forwards any inspection findings that Principal Investigator alone receives in relation to the Study. Whenever feasible and permitted by law, the Health Services Provider will provide CRO and Pfizer with an opportunity to prospectively review and comment on any Health Services Provider responses to regulatory authority inspections in regard to the Study.
Inspection Findings and Responses. Principal Investigator and Institution will promptly forward to CRO and Pfizer copies of any inspection findings that either receives from a regulatory authority in relation to the Study. Whenever feasible and permitted by law, Principal Investigator and Institution will also provide CRO and Pfizer with an opportunity to prospectively review and comment on any responses to regulatory e. Nálezy inspekce a odpovědi. Hlavní zkoušející a Instituce bezodkladně předají CRO a společnosti Pfizer kopie veškerých nálezů inspekce, které kdokoli z nich obdrží od kontrolního úřadu, v souvislosti se Studií. Kdykoli je to proveditelné a povolené ze zákona, Hlavní zkoušející a Instituce také poskytnou CRO a společnosti Pfizer příležitost k případnému posouzení a připomínkám authority inspections in regard to the Study. návrh odpovědí na výsledky inspekce kontrolního úřadu týkající se Studie.
Inspection Findings and Responses. Institution will promptly forward to CRO and Pfizer, or confirm that Principal Investigator has done so, copies of any inspection findings that Institution receives from a regulatory authority in relation to the Study. Institution will also cooperate with Pfizer as needed to help ensure that Principal Investigator forwards any inspection findings e. Nálezy inspekce a odpovědi. Instituce bezodkladně předá CRO a společnosti Pfizer kopie veškerých nálezů inspekce, které obdrží od kontrolního úřadu v souvislosti se Studií, nebo potvrdí, že tak učinil Hlavní zkoušející. Instituce bude rovněž v případě potřeby spolupracovat se společností Pfizer, aby bylo zajištěno, že Hlavní zkoušející předá všechny nálezy inspekce, které sám obdrží v souvislosti se studií. Kdykoli je to proveditelné a povolené ze zákona, poskytne Instituce that Principal Investigator alone receives in relation to the Study. Whenever feasible and permitted by law, Institution will provide CRO and Pfizer with an opportunity to prospectively review and comment on any Institution responses to regulatory authority inspections in regard to the Study. CRO a společnosti Pfizer příležitost k případnému posouzení a připomínkám návrh odpovědí Instituce na výsledky Inspekce kontrolního úřadu týkající se Studie.
Inspection Findings and Responses. AMC will promptly forward to Company copies of any inspection findings (e.g. Establishment Inspection Report, FDA Form 483 or USDA Inspection Report) that it receives from any regulatory agency in relation to the Program. Whenever feasible, AMC will also provide Company with an opportunity to prospectively review and comment on AMC’s responses to regulatory agency inspections in regard to the Program.
Inspection Findings and Responses. Principal Investigator will promptly forward to ABC copies of any inspection findings that Principal Investigator receives from a regulatory agency. Whenever feasible, Principal Investigator will also provide ABC with an opportunity to prospectively review and comment on any Principal Investigator responses to regulatory agency inspections.
Inspection Findings and Responses. Within five (5) days following receipt, Phio or AgonOx (or Approved CRO), as applicable, will provide the JSC with copies of any inspection findings and any other communications that such Party receives from any Governmental Authority with respect to the Product or DP TIL, as applicable, including any Regulatory Authority in connection with the Phase I/II Clinical Trial and any Manufacturing activities and CMC activities of either Party. To the extent practicable, such Party will permit the other Party to prospectively review and comment on any responses to Governmental Authorities in connection the Phase I/II Clinical Trial, including any Regulatory Authorities.
Inspection Findings and Responses. QIAGEN will provide regular updates to Blueprint during the course of any audit performed pursuant to Section 4.3(a) or Section 4.3(b). Within [***] Business Days of receipt, QIAGEN will provide to Blueprint copies of all relevant information and findings pertaining to the matters set forth in Section 4.3(a) and Section 4.3(b), in each case, related to the Activities or that would materially impact either QIAGEN’s ability to obtain Regulatory Approval for, or ensure the clinical or commercial supply of, the QIAGEN IVD being developed for Blueprint under a Project Schedule. Whenever feasible and solely to the extent that it would not compromise the timeliness or quality of the response, QIAGEN will also provide Blueprint with an opportunity to prospectively review and comment on any QIAGEN responses to Regulatory Authorities that relate to Activities. Regardless of whether Blueprint has an opportunity to prospectively review and comment on any QIAGEN responses, QIAGEN will have the final say and determine the appropriate response and provide Blueprint a copy of the response submitted to Regulatory Authorities.
