Common use of FDA Notices Clause in Contracts

FDA Notices. Promptly, and in any event within fifteen (15) Business Days after receipt thereof by any Loan Party or any of their Subsidiaries, copies of each material notice from the FDA (or comparable agency in any applicable non-U.S. jurisdiction or state or local Governmental Authority) concerning any material investigation or other adverse material inquiry, or material and adverse finding or material determination with respect to any product developed, manufactured, sold or distributed by any Loan Party or any of their Subsidiaries (including any notification seeking a recall, removal or corrective action affecting the products developed, manufactured, sold or distributed by such Loan Party or such Subsidiary), including, without limitation, the receipt by any Loan Party or any of their Subsidiaries of any so called “warning letter”, “untitled letter”, FDA Form 483 or similar notification, in each case, from the FDA (or analogous foreign, state or local Governmental Authority) to the extent material to the Parent and its Subsidiaries taken as a whole.

FDA Notices. Promptly, and in any event within fifteen (15) Business Days after receipt thereof by any Loan Party the Borrower or any of their its Subsidiaries, copies of each material notice from the FDA (or comparable agency in any applicable non-U.S. jurisdiction or state or local Governmental Authority) concerning any material investigation or other adverse material inquiry, or material and adverse finding or material determination with respect to any product developed, manufactured, sold or distributed by any Loan Party the Borrower or any of their its Subsidiaries (including any notification seeking a recall, removal or corrective action affecting the products developed, manufactured, sold or distributed by such Loan Party the Borrower or such Subsidiary), including, without limitation, the receipt by any Loan Party the Borrower or any of their its Subsidiaries of any so called “warning letter”, “untitled letter”, FDA Form 483 or similar notification, in each case, from the FDA (or analogous foreign, state or local Governmental Authority) to the extent material to the Parent Borrower and its Subsidiaries taken as a whole.