Common use of Regulační kontroly Clause in Contracts

Regulační kontroly. The Institution and the Investigator shall promptly notify PSI of any inspection or investigation relating to the Study by any regulatory, governmental or law agency (including without limitation the EMA and the US FDA) of which they become aware. PSI, the Sponsor and/or their representatives shall have the right to be present at and/or participate in any such inspection or investigation. Before the Institution or the Investigator submit any materials or information to an agency in connection with an inspection or investigation, PSI and the Sponsor shall have the right to review, provide and/or comment on any such materials and/or information.

Regulační kontroly. The Institution and the Investigator shall promptly notify PSI of any inspection or investigation relating to the Study by any regulatory, governmental or law agency (including without limitation the SÚKL, EMA and the US FDA) of which they become aware. PSI, the Sponsor and/or their representatives shall have the right to be present at and/or participate in any such inspection or investigation. Before the Institution or the Investigator submit any materials or information to an agency in connection with an inspection or investigation, PSI and the Sponsor shall have the right to review, provide and/or comment on any such materials and/or information. The Institution and the Investigator shall provide to the Sponsor and PSI copies of all materials, correspondence, statements, forms and records that the Institution and the Investigator receive, obtain or generate pursuant to or in connection with any such inspection.

Regulační kontroly. The Institution and the Investigator shall promptly without unnecessary delay notify PSI of any inspection or investigation relating to the Study by any regulatory, governmental or law agency (including without limitation the SUKL, EMA and the US FDA) of which they become aware. PSI, the Sponsor and/or their representatives shall have the right to be present at and/or participate in any such inspection or investigation. Before the Institution or the Investigator submit any materials or information to an agency in connection with an inspection or investigation, PSI and the Sponsor shall have the right to review, provide and/or comment on any such materials and/or information.