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.
Sample 1

Examples of Key Regulatory Filings in a sentence

  • 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.

  • Unless exigent action is required with respect to a Key Regulatory Filings and Material Communications, the Regulatory Lead shall provide the other Party with copies of Key Regulatory Filings and Material Communications (which, for clarity, shall not be required to include [***]) (and, if applicable, an English translation) prior to submission within [***]and reasonably consider comments of such other Party in good faith.

  • 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.

  • 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.

  • To the extent permitted under the applicable Kite Partner Agreement, Kite shall provide copies of Key Regulatory Filings it receives from Kite Partner (and extend its rights therein) to DS upon DS’s request.

  • 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.

  • 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.

  • DS shall (i) consult with ARQULE in good faith in the preparation of Key Regulatory Filings for Licensed Products and (ii) consider all comments of ARQULE in good faith, taking into account the due interests of 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.

  • For the avoidance of doubt, Kite shall have the right to provide copies of all Key Regulatory Filings it receives from DS (and extend its rights therein) to Kite Partners.

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 materials developed or compiled in preparation for Regulatory Authority meetings, regulatory applications, submissions, dossiers, notifications, registrations, Regulatory Approvals and/or other filings made to or with, or other approvals granted by, a Regulatory Authority that are necessary or reasonably desirable for the Development, manufacture, market, sale, or Commercialization of a Licensed Product in a particular regulatory jurisdiction.

  • Regulatory Submissions means any filing, application or submission with any Regulatory Authority, including authorizations, approvals or clearances arising from the foregoing, including Regulatory Approvals and any pricing or reimbursement approvals, as applicable, and all correspondence or communication with or from the relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the relevant Regulatory Authority, in each case, with respect to a Licensed Product.

  • 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 and all other documentation submitted, or required to be submitted, to Regulatory Authorities in association with regulatory filings for the Product (including any applicable 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 (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • 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 Licensed 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, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

  • DMF means any drug master file filed with the FDA, and any equivalent filing in other countries or regulatory jurisdictions.

  • 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.

  • 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 has the meaning set forth in Section 3.2.

  • 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,