Common use of Audits by Regulatory Authorities Clause in Contracts

Audits by Regulatory Authorities. If legally permissible, Institution will notify Abbott without unnecessary delay after receipt of any requests by a regulatory authority to inspect or have access to Study documents and will promptly provide Abbott with a copy of any such request, to include copies of any documents received from or provided to regulatory authorities. If legally permissible, Abbott may attend or request to be present during any inspection. Abbott agrees not to alter or interfere with any documentation or practice of Institution. Upon receipt of a regulatory citation or notice relating to this Agreement, Institution agrees to produce a summary within twenty (20) business days that includes an explanation of the issues identified by the regulatory authority and any response thereto.

Appears in 1 contract

Sources: Master Clinical Study Agreement

Audits by Regulatory Authorities. If legally permissible, Institution will notify Abbott without unnecessary delay after within two business days upon receipt of any requests by a regulatory authority to inspect or have access to Study documents and will promptly provide Abbott with a copy of any such request, to include copies of any documents received from or provided to regulatory authorities. If legally permissible, Abbott may attend or request to be present during any inspection. Abbott agrees not to alter or interfere with any documentation or practice of Institution. Upon receipt of a regulatory citation or notice relating to this Agreement, Institution agrees to produce a summary within twenty (20) 10 business days that includes an explanation of the issues identified by the regulatory authority and any response thereto.

Appears in 1 contract

Sources: Master Clinical Study Agreement