Other FDA Correspondence. The Contractor shall memorialize any critical correspondence between Contractor and FDA as related to activities funded under this contract and submit to BARDA. All such documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide such written summary of any FDA correspondence or engagement within 5 business days of correspondence.
Appears in 2 contracts
Samples: Cost Share Contract, Consulting Agreement
Other FDA Correspondence. The Contractor shall memorialize any critical correspondence between Contractor and FDA as related to activities funded under this contract and submit to BARDA. All such documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide such written summary of any FDA correspondence or engagement within 5 business days of correspondence.
Appears in 2 contracts
Samples: Contract (T2 Biosystems, Inc.), Contract (MediWound Ltd.)
Other FDA Correspondence. The Contractor shall memorialize any critical correspondence between Contractor and FDA as related to activities funded under this contract and submit to BARDAthe CO and the COR. All such documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide such written summary of any FDA correspondence or engagement within 5 [**] business days of correspondence.
Appears in 1 contract
Samples: Contract (Summit Therapeutics PLC)
Other FDA Correspondence. The Contractor shall memorialize any critical correspondence between Contractor and FDA as related to activities funded under this contract and submit to BARDA. All such documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide such written summary of any FDA correspondence or engagement within 5 business days [***] of correspondence.
Appears in 1 contract
Samples: Contract (CONTRAFECT Corp)
Other FDA Correspondence. The Contractor shall memorialize any critical correspondence between Contractor and FDA such as related to activities funded under this contract email exchange or telephone conversations in written form and submit to BARDA. Email and telephone call narratives through each month shall be submitted with the monthly report. All such documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide such written summary of any FDA correspondence or engagement within 5 business days [***] of correspondence.
Appears in 1 contract
Samples: Contract (Gritstone Bio, Inc.)