Company Regulatory Filings definition

Company Regulatory Filings shall have the meaning set forth in Section 3.19(a).
Sample 1Sample 2Sample 3
Company Regulatory Filings has the meaning given to such term in Section 3.6(b).
Sample 1Sample 2Sample 3
Company Regulatory Filings shall have the meaning assigned to such term in Section 3.19(e). “Company Reimbursement Approval” and “Company Reimbursement Approvals” shall have the meanings assigned to such terms in Section 3.19(d).
Sample 1Sample 2Sample 3

Examples of Company Regulatory Filings in a sentence

  • All such Company Regulatory Filings complied in all material respects with applicable Legal Requirements.

  • The Company has not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including any of the know-how contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.

  • The Company and the Company Subsidiaries have not granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including, without limitation, any of the know-how contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.

  • All such Company Regulatory Filings substantially complied with applicable Legal Requirements.

  • Section 3.01(k) of the Disclosure Schedule lists each of the Material Contracts that as of the date of this Agreement is in effect or otherwise binding on the Company or any of its Subsidiaries or their respective properties or assets, other than those contracts or agreements that have been filed as exhibits to the Company Regulatory Filings prior to the date of this Agreement.

  • Other than as set forth on Schedule 3(y) (collectively, the "Company Regulatory Filings"), no authorization, consent, approval, order, license or permit from, or filing, registration or qualification with, any government or governmental agency is required to authorize or permit the execution and delivery of this Agreement by the Seller and the consummation by the Seller of the transactions contemplated hereby.

  • Company has made all Company Regulatory Filings with all applicable Governmental Entities for the years ended December 31, 2003, 2004, and 2005 and for each quarterly and annual period ending after December 31, 2005 and prior to the Closing Date (the “Company State Agency Filings”).

  • No Acquired Company has granted any third party any right or license to use, access or reference any of the Company Regulatory Filings, including without limitation, any of the Know-How contained in any of the Company Regulatory Filings or rights (including any regulatory exclusivities) associated with each such Company Regulatory Filing.

  • Upon becoming aware of any Company Regulatory Filings which are required by law but are not listed on Schedule 6.1(d)(i) (other than the filings provided for in Section 2.3 or required under the HSR Act or the Exchange Act), the Company shall promptly notify Purchaser of such Company Regulatory Filings.

  • Any disclosures in the Disclosure Schedule that refer to a document are qualified in their entirety by reference to the text of such document, including all amendments, exhibits, schedules and other attachments thereto, provided that such document has been previously provided to Purchaser or Parent or included in its entirety in the Company Regulatory Filings (including any schedules and exhibits thereto) filed with the SEC prior to the date of this Agreement.


More Definitions of Company Regulatory Filings

Company Regulatory Filings has the meaning assigned in Section 3.01(g)(1).
Sample 1Sample 2
Company Regulatory Filings has the meaning set forth in Section 4.2(g) hereof.
Sample 1Sample 2

Related to Company 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 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 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.

  • Company Filings means all documents publicly filed by or on behalf of the Company on SEDAR since January 1, 2020.

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

  • 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.

  • 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.

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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).

  • Company Reports has the meaning set forth in Section 3.08(a).

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • 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.

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

  • Regulatory entity means any board, commission, agency,

  • 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).

  • 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.

  • national regulatory authority means the body or bodies charged by a Member State with any of the regulatory tasks assigned in this Directive and the Specific Directives;

  • Company Returns is defined in Section 3.15(a) of the Agreement.

  • Regulatory Permits means all Permits granted by the FDA or any comparable Governmental Entity to the Company or any of its Subsidiaries, including investigational new drug applications, Biologics License Applications, manufacturing approvals and authorizations, clinical trial authorizations and ethical reviews, or their national or foreign equivalents.

  • Product Registrations means the Regulatory Approvals necessary to permit the development, manufacture, marketing, import, distribution, or sale of the Products.

  • 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 Authority means any applicable supranational, national, regional, state or local regulatory agency, department, bureau, commission, counsel, or other government entity involved in granting of Regulatory Approval for a Licensed Product in a regulatory jurisdiction within the Territory, including the FDA and the EMEA.

  • Regulatory Laws means all Applicable Laws governing (i) the import, export, testing, investigation, manufacture, marketing or sale of the Product, (ii) establishing recordkeeping or reporting obligations, (iii) any Field Action or (iv) similar regulatory matters.