Common use of Regulatory Inspections Clause in Contracts

Regulatory Inspections. If any governmental or regulatory authority: (i) contacts Institution or Investigator with respect to the Study; (ii) conducts, or gives notice of its intent to conduct, an inspection at Institution; or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of Institution and Investigator, the relevant ethics committee, or Institution or Investigator which could reasonably be expected to impact any data or clinical activity under the Study; Institution and Investigator must promptly notify MedImmune of the contact or notice. MedImmune, and/or CRO will have the right to be present at and to participate in any such inspection or regulatory action with respect to the Study. Institution and Investigator must provide MedImmune with copies of all information and documentation applicable to the Study issued by any governmental or regulatory authority and any proposed response. MedImmune and CRO will have the right to review and comment in advance on any responses which pertain to the Study, but acknowledge that MedImmune shall only advise Institution and Investigator in such responses. No such response will contain any false or misleading information with respect to the Study, the Study Drug, CRO or MedImmune. If the Institution or Investigator is provided an inspection report from the governmental or regulatory authority, a copy of such report shall be provided to MedImmune within forty-eight

Regulatory Inspections. If any governmental or regulatory authority: (i) contacts Institution or Investigator with respect to the Study; (ii) conducts, or gives notice of its intent to conduct, an inspection at Institution; or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of Institution and Investigator, the relevant ethics committee, or Institution or Investigator which could reasonably be expected to impact any data or clinical activity under the Study; Institution and Investigator must promptly notify MedImmune of the contact or notice. MedImmune, and/or CRO will have the right to be present at and to participate in any such inspection or regulatory action with respect to the Study. Institution and Investigator must provide MedImmune with copies of all information and documentation applicable to the Study issued by any governmental or regulatory authority and any proposed response. MedImmune and CRO will have the right to review and comment in advance on any responses which pertain to the Study, but acknowledge that MedImmune shall only advise Institution and Investigator in such responses. No such response will contain any false or misleading information with respect to the Study, the Study Drug, CRO or MedImmune. If the Institution or Investigator is provided an inspection report from the governmental or regulatory authority, a copy of such report shall be provided to MedImmune within forty-eighteight (48) hours of its receipt by the Institution and Investigator. Institution and Investigator must use best efforts to properly address and will cure any and all non‑compliance issues, and will consult and inform MedImmune in all respects to the actions taken and the responses provided to any report or correspondence issued by any governmental authority which could reasonably be expected to impact the Study.

Regulatory Inspections. If any governmental or regulatory authority: (i) contacts Institution or Investigator with respect to the Study; (ii) conducts, or gives notice of its intent to conduct, an inspection at Institution; or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of Institution and Investigator, the relevant ethics committee, or Institution or Investigator which could reasonably be expected to impact any data or clinical activity under the Study; Institution and Investigator must promptly notify MedImmune of the contact or notice. MedImmune, and/or CRO will have the right to be present at and to participate in any such inspection or regulatory action with respect to the Study. Institution and Investigator must provide MedImmune with copies of all information and documentation applicable to the Study issued by any governmental or regulatory authority and any proposed response. MedImmune and CRO will have the right to review and comment in advance on any responses which pertain to the Study, but acknowledge that MedImmune shall only advise Institution and Investigator in such responses. No such response will contain any false or misleading information with respect to the Study, the Study Drug, CRO or MedImmune. If the Institution or Investigator is provided an inspection report from the governmental or regulatory authority, a copy of such report shall be provided to MedImmune within forty-eighteight (48) hours of its receipt by the Institution and Investigator. Institution and Investigator must

Regulatory Inspections. If any governmental or regulatory authority: (i) contacts Institution or Investigator with respect to the Study; (ii) conducts, or gives notice of its intent to conduct, an inspection at Institution; or (iii) takes, or gives notice of its intent to take, any other regulatory action with respect to any activity of Institution and Investigator, the relevant ethics committee, or Institution or Investigator which could reasonably be expected to impact any data or clinical activity under the Study; Institution and Investigator must promptly notify MedImmune of the contact or notice. MedImmune, and/or CRO will have the right to be present at and to participate in any such inspection or regulatory action with respect to the Study. Institution and Investigator must provide MedImmune with copies of all information and documentation applicable to the Study issued by any governmental or regulatory authority and any proposed response. MedImmune and CRO will have the right to review and comment in advance on any responses which pertain to the Study, but acknowledge that MedImmune shall only advise Institution and Investigator in such responses. No such response will contain any false or misleading information with respect to the Study, the Study Drug, CRO or MedImmune. If the Institution or Investigator is provided an inspection report from the governmental or regulatory authority, a copy of such report shall be provided to MedImmune within forty-eightshall