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. 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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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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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.

  • 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 NYISO and Connecting Transmission Owner shall file this Agreement (and any amendment hereto) with the appropriate Governmental Authority, if required. Any information related to studies for interconnection asserted by Developer to contain Confidential Information shall be treated in accordance with Article 22 of this Agreement and Attachment F to the ISO OATT. If the Developer has executed this Agreement, or any amendment thereto, the Developer shall reasonably cooperate with NYISO and Connecting Transmission Owner with respect to such filing and to provide any information reasonably requested by NYISO and Connecting Transmission Owner needed to comply with Applicable Laws and Regulations.

  • 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 Each Party represents and warrants that it has, or applied for, all regulatory authorizations necessary for it to perform its obligations under this Agreement.

  • 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.

  • COPIES OF REGULATORY REPORTS AND FILINGS Upon reasonable request, Competitive Supplier shall provide to the Town a copy of each public periodic or incident-related report or record relating to this ESA which it files with any Massachusetts or federal agency regulating rates, service, compliance with environmental laws, or compliance with affirmative action and equal opportunity requirements, unless the Competitive Supplier is required by law or regulation to keep such reports confidential. The Town shall treat any reports and/or filings received from Competitive Supplier as confidential information subject to the terms of Article 16. Competitive Supplier shall be reimbursed its reasonable costs of providing such copies.

  • Reports and Filings Assist in the preparation of (but not pay for) all periodic reports by the Fund to its shareholders and all reports and filings required to maintain the registration and qualification of the Funds and Fund shares, or to meet other regulatory or tax requirements applicable to the Fund , under federal and state securities and tax laws.

  • 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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