FDA Correspondence. Each of Mylan and Insys shall promptly inform the other of any correspondence from the FDA regarding the Product that would materially affect its ability to meet its obligations under this Agreement. Each of Mylan and Insys shall notify the other promptly of any materially adverse inspections by the FDA or other regulatory authorities which pertain to the Product or to the facilities of such Party or its Affiliate where the Product are being manufactured or stored, or any occurrences or information that arise out of Insys’ manufacturing activities that have or could reasonably be expected to have adverse regulatory compliance or reporting consequences concerning the Product or which might otherwise be reasonably expected to adversely affect the supply by Insys of Product to Mylan.
FDA Correspondence. 3.4.1 To the extent either Party receives any material written or oral communications relating to any Licensed Product from the FDA, such Party will promptly inform the other Party thereof (including by providing a copy of any such written communication or a written account of any such oral communication), but in no event later than five business days after receipt of such communication. The Party that is responsible for communicating with the FDA in connection with the development, registration or Commercialization of any Licensed Product at issue under the terms of this Agreement (i.e., the Party holding the NDA—the “Communicating Party”) will use reasonable efforts to solicit the other Party’s advice and review of the nature and text of any written communications received from or to be sent to the FDA in reasonably sufficient time prior to responding or dispatching such communications to the FDA, and the Communicating Party will consider in good faith the other Party’s reasonable comments related thereto.
FDA Correspondence. The Company will (i) consult with Parent prior to any communication or correspondence with, or delivery of notice, supplemental reports or materials to, the FDA in connection with the Company’s efforts to obtain 510(k) clearance for the Accell Products and (ii) promptly provide Parent with copies of any correspondence with the FDA and any written comments, notices, supplemental reports or materials received from or provided to the FDA and promptly advise Parent of any oral communications with the FDA.
FDA Correspondence. Subject to applicable Law and applicable confidentiality agreements with any Person, the Company shall promptly provide Parent with copies of any material correspondence with the FDA and any material written comments, notices, supplemental reports or materials received from or provided to the FDA and promptly advise Parent of any oral communications with the FDA.
FDA Correspondence. Following receipt of a Product Approval for a Product Genpharm and Resources shall provide the other (and Genpharm shall cause each Manufacturer to provide Resources) with a copy of any correspondence or notices received by such party from the FDA relating to or referring to such Product within 10 days of receipt and a copy of any response to any such correspondence or notices with 10 days of making a response.
FDA Correspondence. Following receipt of a Product Approval for a Product Genpharm and PRI shall provide the other (and Genpharm shall cause each Manufacturer to provide PRI) with a copy of any correspondence or notices received by such party from the FDA relating to or referring to such Product within 10 days of receipt and a copy of any response to any such correspondence or notices with 10 days of making a response.
FDA Correspondence. Borrower agrees to promptly (and in any case not later than three Business Days after submission or receipt) provide to Lender copies of material correspondence to or from the FDA related to any Product including, without limitation, any FDA action letters. Additionally, Borrower shall use commercially reasonable efforts to keep Lender informed of, and provide copies of material data and other primary documents regarding, all material Product developments, including, clinical trial results, other regulatory communications, Intellectual Property status, prescription and net sales data, and manufacturing and supply information.
FDA Correspondence. Columbia agrees to promptly (and in any case not later than three Business Days after receipt) provide to PharmaBio copies of material correspondence to or from the FDA related to the Product including, without limitation, any Not Approvable Letter or other FDA action letters.
FDA Correspondence. The Company has not received any warning letter, untitled letter or other correspondence or notice from the FDA or any similar regulatory authority alleging or asserting noncompliance by the Company. The Company is not a party to, or has any ongoing reporting obligations pursuant to, any corporate integrity agreement, deferred prosecution agreement, monitoring agreement, consent decree, settlement order, plan of correction or similar agreement imposed by any governmental authority.
FDA Correspondence. Promptly provide to Lender copies of all correspondence, notices, orders and other writings (a) delivered to any Borrower or any agent, counsel or other representative of any Borrower by the United States Food and Drug Administration ("FDA"), or (b) delivered to the FDA by any Borrower or any agent, counsel or other representative of any Borrower.
