Key Regulatory Filings definition

Key Regulatory Filings means any (i) Investigational New Drug Application (or similar filing outside the United States); (ii) Biologic Licensing Application (or similar filing outside the United States); (iii) briefing books; and (iv) any other Regulatory Filing designated a Key Regulatory Filing by written agreement of the Parties.
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Key Regulatory Filings means (a) any IND, NDA, sNDA, other Drug Approval Applications, application for designation as an “Orphan Product(s)” under the Orphan Drug Act, for “Fast Track” status under Section 506 of the FDCA (21 U.S.C. § 356) or for a Special Protocol Assessment under Section 505(b)(4)(B) and (C) of the FDCA (21 U.S.C. § 355(b)(4)(B)) and counterparts to the foregoing in the EU or any Major European Country, periodic safety update reports, and briefing documents presented to the FDA, the EMA or any Regulatory Authority in any Major European Country, (b) all supplements and amendments to any of the foregoing, and (c) any Regulatory Filing relating to the Licensed Product label, Targeted Indications, warnings, side effects and precautions.
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Key Regulatory Filings means IND, CTA, CTN and MAA filings, protocols and substantive protocol amendments, substantive amendments to CTN and MAA, or any material documents, information or correspondence received from or delivered to a Regulatory Authority, in each case for the Licensed Product. For purposes of this Section 5.2.1, material documents, information or correspondence includes any communications from a Regulatory Authority that could potentially impact safety or labeling for a Licensed Product in the Territory.
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Examples of Key Regulatory Filings in a sentence

  • Without limiting the foregoing, DS will provide Kite with summaries, overviews, or excerpts (in English) of all Key Regulatory Filings (as defined below) prior to filing thereof.

  • In the case of an exigent action, the Regulatory Lead shall use reasonable efforts to notify the other Party prior to making any Key Regulatory Filings and Material Communications for the Product and, thereafter, the Regulatory Lead shall use reasonable efforts to provide the other Party with a copy (and, if applicable, an English translation) of such Key Regulatory Filings and Material Communications within [***] after making such Key Regulatory Filings and Material Communications.

  • Currently, mostly banks deal in BoEs, and usually the acceptance and discounting are kept under the credit limit set up for the buyer.

  • DS shall in good faith prepare Key Regulatory Filings for Licensed Products, taking into account the due interests of both DS and ARQULE and the Development and Commercialization of the Licensed Product on a global basis.

  • For the purpose of this Section 4.7, “exigent action” shall mean an action that, in the good faith determination of the Regulatory Lead, requires attention on an expedited basis that does not allow for advance copies of Key Regulatory Filings and Material Communications required by this Section 4.7 and is not attributable to the fault of the Regulatory Lead.

  • The Regulatory Lead shall consult with the other Party regarding, and keep such other Party informed of, the status of the preparation of all Key Regulatory Filings and Material Communications (which, for clarity, shall not be required to include [***]) it submits, Governmental Authority review of any such Regulatory Filings, Regulatory Authority responses to such material communications, and all associated Regulatory Approvals that it obtains with respect to the Product.

  • Mr. Siciliano discussed the update on the 1.85% tax and 2% tourism tax collections, which were distributed to the Board.

  • In addition, subject to any Third Party confidentiality obligations, DS shall (i) provide ARQULE with copies of each Key Regulatory Filing or correspondence pertaining to a Licensed Product at the same time as it is provided to FDA or other Regulatory Authority, and (ii) promptly provide ARQULE with copies of the document or other correspondence received from the FDA or other Regulatory Authority which relates to such Key Regulatory Filings pertaining to any Licensed Product.

  • The Regulatory Lead shall provide to the other Party copies of all Key Regulatory Filings and Material Communications (and, if applicable, an English translation) with respect to the Product it submits promptly after the submission (but in no event later than [***] after submission) and copies of all material correspondence with or received from Regulatory Authorities.

  • Author- itarians generally do not hold egalitarian attitudes, are intolerant, and do not value freedom of expression.

Related to Key Regulatory Filings

  • Regulatory Filings means any submission to a Regulatory Authority of any appropriate regulatory application together with any related correspondence and documentation, and will include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.

  • Regulatory Filing means any filing with any Governmental Authority with respect to the research, development, manufacture, distribution, pricing, reimbursement, marketing or sale of a Product.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Materials means, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • Regulatory Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Regulatory Data means any and all research data, pharmacology data, chemistry, manufacturing, and control data, preclinical data, clinical data or all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product in the Field (including any Drug Master Files (DMFs), Chemistry, Manufacturing and Control (“CMC”) data, or similar documentation).

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation, all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Regulatory Documentation means, with respect to the Compounds, all submissions to Regulatory Authorities in connection with the development of such Compounds, including all INDs and amendments thereto, NDAs and amendments thereto, drug master files, correspondence with regulatory agencies, periodic safety update reports, adverse event files, complaint files, inspection reports and manufacturing records, in each case together with all supporting documents (including documents that include Clinical Data).

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • DMF means a drug master file, as provided for in 21 CFR § 314.420 or similar submission to or file maintained with the FDA or other Governmental Authority or Regulatory Authority that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Regulatory Documents means the prospectus, annual report, semi-annual report and any other document required under applicable federal securities law to be delivered by the Trust to Fund shareholders.

  • WTO GPA country end product means an article that—

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Product Approval(s) means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Development Plans means a coherent set of operations defined and financed exclusively by the OCTs in the framework of their own policies and strategies of development, and those agreed upon between an OCT and the Member State to which it is linked;

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • Promotional Materials means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, without limitation, journal advertisements, sales visual aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, internet postings and sites and broadcast advertisements intended for use or used by either Party or its Affiliates or sublicensees in connection with any promotion of a Product.

  • Regulatory entity means any board, commission, agency,