Common use of Government Notices Clause in Contracts

Government Notices. Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt. Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ASD to the extent related to the Product and to the extent reasonably feasible. Where reasonably possible, ASD shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ASD's facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.

Appears in 1 contract

Samples: Distribution Services Agreement (Dyax Corp)

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Government Notices. Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt. Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ASD to the extent related to the Product and to the extent reasonably feasible. Where reasonably possible, ASD shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ASD's ’s facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.

Appears in 1 contract

Samples: Distribution Services Agreement (Dyax Corp)

Government Notices. Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt. Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ASD ICS to the extent related to the Product and to the extent reasonably feasible. Where reasonably possible, ASD ICS shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ASD's ICS’s facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.

Appears in 1 contract

Samples: Distribution Services Agreement (Dyax Corp)

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Government Notices. Each party shall provide the other with a copy of any correspondence or notices it receives from the FDA, or other governmental entity specifically relating to the Product or activities conducted under this Agreement, no later than one (1) business day following such receipt. Each party shall also provide the other with concurrent copies of any responses to any such correspondence or notices (e.g., a response to an FDA 483 notice, warning letter, or untitled regulatory letter); provided that Dyax shall review and approve all such responses by ASD ICS to the extent related to the Product and to the extent reasonably feasible. Where reasonably possible, ASD ICS shall give prior notice to Dyax of any scheduled FDA or other governmental inspection of ASDICS's facilities specifically relating to the Product, and, if reasonably possible, will afford Dyax the opportunity to be present at such inspection.

Appears in 1 contract

Samples: Distribution Services Agreement (Dyax Corp)

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