NDA Filings Sample Clauses

NDA Filings. Anthra agrees to prepare and file an NDA for the Product for each of the CIS Indication and the Papillary Indication and to use commercially reasonable efforts to obtain approval thereof. Promptly upon the completion (and prior to the filing) of each such NDA, Anthra shall provide Medeva with a copy of the Chemistry, Manufacturing, and Controls (CMC) section thereof, and agrees to delay the filing of such NDA with the FDA for a period of sixty (60) days after the date such copy was provided to Medeva, unless the EMC shall unanimously approve the filing of such NDA prior to the end of such period. Insofar as timely received, Medeva's reasonable views and requests shall be taken into account prior to the submission of such NDA. All such NDAs shall be filed in the name of Anthra, but shall be held subject to the Medeva Interest as herein provided, and Anthra shall use commercially reasonable efforts to maintain such NDAs after approval thereof.
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NDA Filings. Upon and from the execution of this Agreement, Juventas shall use Commercially Reasonable Efforts to obtain, control and maintain NDA approvals in the Territory for the Licensed Product in accordance with the R&D Plan, including preparing and submitting a product dossier and such other materials as may be required for classification and approval of the Licensed Product for the sale and marketing in the Territory by the NMPA or other applicable Government or Regulatory Authority in the Territory. Juventas shall bear all costs associated with obtaining and maintaining all Regulatory Approvals in the Territory, including all costs associated with any regulatory filings related to the Licensed Product, and any post- marketing studies necessary to obtain or maintain Regulatory Approval.
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NDA Filings. Subject to the terms of any CO-COMMERCIALIZATION AGREEMENT with MERCK KGAA pursuant to Section 5.3, GENAISSANCE will prepare and file, at its expense, all REGULATORY APPLICATIONS.
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Related to NDA Filings

  • Patent Filings The Party responsible for Prosecution and Maintenance of any Patent Rights as set forth in Section 7.2.2 and Section 7.2.3 will endeavor to obtain patent protection for a Product as it Prosecutes and Maintains its other patents Covering products in development, using counsel of its own choice but reasonably acceptable to the other Party, in such countries as the responsible Party sees fit.

  • Regulatory Filings and Approvals Copies of all necessary governmental and third party approvals, registrations, and filings in respect of the transactions contemplated by this Agreement;

  • HSR Filings Each party hereto shall file or cause to be filed with the Federal Trade Commission and the Department of Justice any notifications required to be filed under the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended (the "HSR Act"), and the rules and regulations promulgated thereunder with respect to the transactions contemplated hereby. Such parties will use all reasonable efforts to coordinate such filings and any responses thereto, to make such filings promptly and to respond promptly to any requests for additional information made by either of such agencies.

  • Regulatory Filings Except as disclosed in the Registration Statement and the Prospectus, neither the Company nor any of its Subsidiaries has failed to file with the applicable Governmental Authorities (including, without limitation, the FDA, or any foreign, federal, state, provincial or local Governmental Authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission, except for such failures that, individually or in the aggregate, would not have a Material Adverse Effect; except as disclosed in the Registration Statement and the Prospectus, all such filings, declarations, listings, registrations, reports or submissions were in compliance with applicable laws when filed and no deficiencies have been asserted by any applicable regulatory authority with respect to any such filings, declarations, listings, registrations, reports or submissions, except for any deficiencies that, individually or in the aggregate, would not have a Material Adverse Effect. The Company has operated and currently is, in all material respects, in compliance with the United States Federal Food, Drug, and Cosmetic Act, all applicable rules and regulations of the FDA and other federal, state, local and foreign Governmental Authority exercising comparable authority. The Company has no knowledge of any studies, tests or trials not described in the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Prospectus.

  • Other Regulatory Approvals Each party hereto shall cooperate and use its reasonable best efforts to promptly prepare and file all necessary documentation to effect all necessary applications, notices, petitions, filings and other documents, and use all reasonable efforts to obtain (and will cooperate with each other in obtaining) any consent, acquiescence, authorization, order or approval of, or any exemption or nonopposition by, any Governmental Entity required to be obtained or made by Parent or the Company or any of their respective Subsidiaries in connection with the Offer and the Merger or the taking of any other action contemplated by this Agreement.

  • Regulatory Authorizations (i) All material Consents of any Governmental Authorities shall have been obtained and shall be in full force and effect, and (ii) the applicable waiting period under the HSR Act shall have expired or been terminated.

  • Filings The Company will file with the Commission such reports as may be required by Rule 463 under the Securities Act.

  • Necessary Filings 3 2.2. No Liens.........................................................3 2.3.

  • Transfer Filings (i) The Seller is the sole owner of all the rights and interests under the Financing Order to be sold to the Issuer on the Closing Date.

  • Regulatory Approvals All Requisite Regulatory Approvals shall have been obtained and shall remain in full force and effect and all statutory waiting periods in respect thereof shall have expired, and no such Requisite Regulatory Approval shall have resulted in the imposition of any Materially Burdensome Regulatory Condition.

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