FDA Filings Clause Samples
The FDA Filings clause outlines the responsibilities and procedures related to submitting documents and information to the U.S. Food and Drug Administration (FDA). It typically specifies which party is responsible for preparing, filing, and maintaining regulatory submissions, such as Investigational New Drug (IND) applications or New Drug Applications (NDA), and may address the sharing of regulatory correspondence or updates. This clause ensures that regulatory compliance is maintained throughout the development and commercialization process, clarifying roles and reducing the risk of miscommunication or regulatory delays.
FDA Filings. The Client shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be required for the receipt of FDA Approval for the commercial manufacture of the Drug Product. Patheon shall assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain FDA Approval for the commercial manufacture of the Drug Product as quickly as reasonably possible.
FDA Filings. Introgen shall be responsible for the preparation and filing of all IND's in North America with respect to the Collaboration Products, which shall be filed in Introgen's name; provided RPRP shall have a reasonable opportunity to review and comment upon such filings in advance of their filing. RPRP shall be responsible for all further submissions to existing INDs once Later Stage Clinical Development has begun, provided that Introgen is given a reasonable opportunity to review and comment upon such submissions prior to the filing of such submissions. Introgen shall cooperate in transferring to RPRP authority for such correspondence. RPRP, at its expense, shall prepare all PLAs and ELA's for filing in North America with respect to each Collaboration Product. All such PLA's and ELA's shall be filed in the names of RPRP and Introgen, to the extent permitted by applicable FDA regulations (taking into account the supply arrangements under Section 12.3. below), or in such other manner as the Development Committee approves. In addition, RPRP shall in all events have the right to file separately a PLA/ELA in its own name to qualify, as a permitted supply source for the United States, its manufacturing facility for the RPRP Territory (consistent with Section 12.3. below).
FDA Filings. Purchaser will use its reasonable efforts in good faith promptly to file or cause to be filed with the FDA, any notice, document and/or other materials required to be filed by it in connection with its purchase of the Acquired Assets (including without limitation the filings required by 21 CFR Section 314.72) and to make promptly any further filings and take any actions required of it as may be necessary to consummate the transactions contemplated hereby.
FDA Filings. Purchaser will use its reasonable efforts in good faith to file or cause to be filed with the FDA, by August 5,1996, the notice, documents and/or other materials required to be filed by it in connection with its purchase of the Acquired Assets and to make promptly any further filings and take any actions required of it as may be necessary to consummate the transactions contemplated hereby.
FDA Filings. Targacept will use commercially reasonable efforts in good faith promptly to file or cause to be filed with the FDA, any notice, document and/or other materials required to be filed by it in connection with its purchase of the Acquired Assets (including, without limitation, the filings required by 21 CFR Section 314.72) and to make promptly any further filings and take any actions required of it as may be necessary to consummate the transactions contemplated hereby.
FDA Filings. Sepracor shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be required for the receipt of FDA Approval for the commercial manufacture of all of the Products. The Patheon Administrator shall assist Sepracor, to the extent consistent with Patheon's obligations under this Agreement, to obtain FDA Approval for the commercial manufacture of all Products as quickly as reasonably possible.
FDA Filings. Promptly DMC shall make all necessary filings with ----------- the Food and Drug Administration concerning its x-ray products.
FDA Filings. The Client shall have the sole responsibility for filing all documents with the FDA and taking any other actions that may be required for the receipt of FDA Approval for the commercial manufacture of all of the Products. Patheon shall assist the Client, to the extent consistent with Patheon’s obligations under this Agreement, including, but not limited to, the obligations under clause (a) of this Section 7.8 above, to obtain FDA Approval for the commercial manufacture of all Products as quickly as reasonably possible. Copies of all relevant CMC (as hereinafter defined) submissions and any related FDA correspondence are to be provided to Patheon by the Client.
FDA Filings. Except as would not result in a Material Adverse Effect, the Company (including its Subsidiaries) has not failed to file with the applicable regulatory authorities (including the FDA or any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA and having jurisdiction over the Company) any filing, declaration, listing, registration, report or submission that is required to be so filed for the Company’s business operation as currently conducted. All such filings were in material compliance with applicable laws when filed and no material deficiencies have been asserted in writing by any applicable regulatory authority (including, without limitation, the FDA or any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) with respect to any such filings, declarations, listings, registrations, reports or submissions.
FDA Filings. VESTA will use commercially reasonable efforts in good faith promptly to file or cause to be filed with the FDA, any notice, document and/or other materials required to be filed by it in connection with its purchase of the Acquired Assets (including, without limitation, the filings required by 21 CFR Section 314.72) and to make promptly any further filings and take any actions required of it as may be necessary to consummate the transactions contemplated hereby.