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 [CONFIDENTIAL TREATMENT REQUESTED] the other Party’s [CONFIDENTIAL TREATMENT REQUESTED] comments related thereto.
3.4.2 Each Party will promptly notify the other Party, and provide such other Party with a copy, of any material correspondence or other reports or complaints submitted to or received by the first Party from the FDA or any Third Party claiming that any Promotional Materials are inconsistent with any Licensed Product labeling or are otherwise in violation of applicable law or regulation.
3.4.3 Each Party will provide the other Party with a copy of any material documents or reports filed with the FDA during the Term with respect to any Licensed Product.
3.4.4 Prior to the transfer of the POZEN NDA to Xcel from POZEN pursuant to Section 3.1.2, (a) Xcel will be provided with the opportunity to have an observer in attendance at any in-person meetings or pre-scheduled telephone calls with the FDA with respect to any Licensed Product and (b) the Parties will agree on any change to the labeling for the Initial Licensed Product (as compared with the draft label included in the POZEN NDA as of the Effective Date). [CONFIDENTIAL TREATMENT REQUESTED].
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. 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. 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. 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. 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. Each of Mylan and DPSI 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 DPSI 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 is being manufactured or stored, or any occurrences or information that arise out of DPSI’s or Mylan’s manufacturing activities that could have reasonably been expected to have adverse regulatory compliance or reporting consequences concerning any Product or which might otherwise be reasonably expected to adversely affect the supply by DPSI of the Product to Mylan. Mylan agrees that DPSI shall be solely responsible for responding to any correspondence from the FDA relating to the Product and shall be the sole point of contact with the FDA regarding the Product. DPSI will give Mylan thirty (30) days (or such other amount of time as may be imposed on DPSI) to review and comment on any proposed communications with the Office of Generic Drugs of the FDA that in DPSI’s opinion materially affect (excluding periodic and routine reports) the Product and shall take Mylan’s comments which are received within the required time, if any, into account in communicating with FDA.
