FDA Notices Clause Samples
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FDA Notices. Promptly, and in no event later than three (3) Business Days after an Authorized Officer becomes aware thereof, notify and provide copies to the Administrative Agent of any notice and related correspondence that (i) the FDA or any other similar Governmental Authority is limiting, suspending or revoking any material Registration, changing the Product Approval, manufacturing process or facilities, distribution pathway or parameters, or label or labeling of the Products of the Credit Parties or their respective Subsidiaries, or considering any of the foregoing; (ii) any Credit Party or any of its Subsidiaries becoming subject to any administrative or regulatory action, including FDA application integrity review, Form FDA 483 observation or other inspection-related or audit documents, warning letter, untitled letter, notice of violation letter, penalty, fine, sanction or reprimand, or other notice, response or commitment made to or with the FDA or any comparable Governmental Authority, or any Product of any Credit Party or any of its Subsidiaries being seized, withdrawn, recalled (voluntarily or otherwise), detained, or subject to a suspension of manufacturing, or the commencement of any proceedings in the United States or any other jurisdiction seeking the withdrawal, recall (voluntary or otherwise), suspension, import detention, or seizure of any Product are pending or threatened in writing against the Credit Parties or their respective Subsidiaries; and (iii) any voluntary withdrawal or recall of any Product by any Credit Party or any of its Subsidiaries in an aggregate amount of $500,000 or which would, in the aggregate, have a Material Adverse Effect.
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. The Borrower shall provide to the Administrative Agent (to the extent not otherwise required to be provided pursuant to Section 7.05):
(a) promptly after the same become available to the Borrower, with respect to each manufacturing facility of the Borrower or its Subsidiaries, all warning letters alleging violations of FDA regulatory requirements at such manufacturing facility that would be required to be publicly disclosed by the Borrower in a filing with the Commission as determined by the Borrower;
(b) promptly after the same become available to the Borrower, with respect to each manufacturing facility of the Borrower or its Subsidiaries, all inspectional observations recorded on a Form FD 483 and issued by the FDA at the conclusion of any FDA inspections of such facility (other than pre-approval inspections and post-approval inspections) that would be required to be publicly disclosed by the Borrower in a filing with the Commission as determined by the Borrower; and
(c) all written responses to the FDA by or on behalf of the Borrower or its Subsidiaries concerning alleged violations of FDA regulatory requirements contained in warning letters or Form FD 483s referred to in subsections (a) or (b) of this Section 7.08.
FDA Notices. The Borrower shall provide to the Administrative Agent:
(a) promptly after the same become available to the Borrower, with respect to each manufacturing facility of the Borrower or its Subsidiaries, all warning letters alleging violations of FDA regulatory requirements at such manufacturing facility;
(b) promptly after the same become available to the Borrower, with respect to each manufacturing facility of the Borrower or its Subsidiaries, all inspectional observations recorded on a Form FD 483 and issued by the FDA at the conclusion of any FDA inspections of such facility (other than pre-approval inspections and post-approval inspections) that would be required to be publicly disclosed by the Borrower in a filing with the Commission as determined by the Borrower; and
(c) all written responses to the FDA by or on behalf of the Borrower or its Subsidiaries concerning alleged violations of FDA regulatory requirements contained in warning letters or Form FD 483s referred to in subsections (a) or (b) of this Section 7.10.
FDA Notices. Promptly (and in any event within three (3) Business Days) after any Borrower has knowledge of any violation, claim, complaint or charge, or receipt of any violation, claim, complaint or charge, of or under the Food and Drug Act or any applicable statutes, rules, regulations, guidelines, policies, orders or directives administered or issued by the FDA, including receipt by any Borrower or any of its Subsidiaries of any Product Recall Notice, other FDA notice or amendment to such a previous Product Recall Notice or FDA notice that is required to be disclosed under this Section 8.3(k), that is material to the interests of Agent, the Lenders or the Holders, a statement of an authorized officer of the Borrowers setting forth the material details of such occurrence and the actions, if any, which the Borrowers propose to take with respect thereto and, in the case of a written document evidencing such event, together with a true, correct and complete copy of such Product Recall Notice, FDA Notice or amendment or other notice, as the case may be (other than to the extent that provision of such documents or information to the Agent and the Holders would invalidate any privileged status granted by such Governmental Authority with respect to such documents or information, in which case, the Borrowers shall furnish a summary of the documents or information so provided that does not invalidate such privilege); and
FDA Notices. On the Closing Date, the Company shall have notified the FDA of the transfer of the Company Business to Buyer as contemplated by the Merger, in customary form.
FDA Notices. CPT agrees to notify MDC within five (5) business days of any FDA inspection of the CPT facilities and will upon receipt promptly provide MDC copies of any 483 citations/observations or warning letters issued by the FDA.