BD Regulatory Filings definition

BD Regulatory Filings has the meaning set forth in Section 2.19(a).
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BD Regulatory Filings has the meaning set forth in Section 4.33(c). “beneficial ownership,” including the correlative term “beneficial owner,” has the meaning ascribed to such term in Section 13(d) of the Exchange Act.
Sample 1

Examples of BD Regulatory Filings in a sentence

  • The Company has timely filed all BD Regulatory Filings and such filings are, to the extent applicable, in full force and effect and were prepared in all material respects in compliance with applicable Law, including the requirements of the Exchange Act, FINRA rules (“FINRA Rules”) and State Securities Laws, and all material fees and assessments due and payable in connection with the filing of such BD Regulatory Filings have been paid in a timely manner.

  • Schedule 3.18(a) sets forth a complete list of the identities of each principal and registered representative of the Company, their series licenses, and all BD Regulatory Filings filed since January 1, 2013.

  • The documents identified in items (i) and (iii) in the definition of BD Regulatory Filings and, to the Knowledge of any Seller, the documents identified in items (ii) of the definition of BD Regulatory Filings, do not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.

  • Since December 31, 2016, the information contained in VAE’s BD Regulatory Filings, including the information contained in VAE’s Form BD as most recently filed with the SEC, was true, complete and correct in all material respects at the time of filing, and VAE has made all material amendments to such BD Regulatory Filings as it is required to make under any Applicable Law.

  • Except as set forth in Schedule 2.8(a), the information contained in the BD Regulatory Filings was true, complete and correct at the time of filing, and the Broker-Dealer Subsidiary has made all amendments to such BD Regulatory Filings as it is required to make under any applicable Legal Requirements.

  • The documents identified in items (i) and (iii) in the definition of BD Regulatory Filings and, to the Knowledge of Seller, the documents identified in items (ii) of the definition of BD Regulatory Filings, do not and will not contain any untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein, in light of the circumstances under which they were made, not misleading.

  • Since December 31, 2017, the information contained in Allstate Distributors’ BD Regulatory Filings was true, complete and correct in all material respects at the time of filing, and Allstate Distributor has made all material amendments to such BD Regulatory Filings as it is required to make under any Applicable Law.

  • Since January 1, 2016, the information contained in HFF Securities’ BD Regulatory Filings, including the information contained in HFF Securities’ Form BD as most recently filed with the SEC, was true, complete and correct in all material respects at the time of filing, and HFF Securities has made all material amendments to such BD Regulatory Filings as it is required to make under any applicable Law.

  • Since December 31, 2014, the information contained in DSL’s BD Regulatory Filings, including the information contained in DSL’s Form BD as most recently filed with the SEC, was true, complete and correct in all material respects at the time of filing, and DSL has made all material amendments to such BD Regulatory Filings as it is required to make under any Applicable Law.

  • Since January 1, 2018, the information contained in GAAI’s BD Regulatory Filings was true, complete and correct in all material respects at the time of filing, and GAAI has made all material amendments to such BD Regulatory Filings as it is required to make under any applicable Law.

Related to BD Regulatory Filings

  • 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.

  • Regulatory Filings means all applications, filings, dossiers and the like submitted to a Regulatory Authority in a particular jurisdiction for the purpose of obtaining Regulatory Approval of a Licensed Product from that regulatory authority with respect to such jurisdiction. Regulatory Filings shall include, but not be limited to, all INDs and Drug Approval Applications for Licensed Product.

  • Regulatory Materials means regulatory applications, submissions, notifications, registrations, Marketing Authorizations or other written materials, correspondence, submissions made to or with a Regulatory Authority that are necessary or reasonably desirable in order to Develop, Manufacture or Commercialize the Licensed Products in the Field in a particular country.

  • 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 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 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).

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

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

  • 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 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.

  • 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 Authorities means the Commissions and the Exchange;

  • 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.

  • Marketing Materials has the meaning ascribed thereto in NI 41-101;

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

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

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Drug Master File or “DMF” is described in 21 C.F.R. Part 314.420. A DMF is a submission to the FDA 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.

  • DMF means a drug master file and all equivalents, and related proprietary dossiers, in any country or jurisdiction in the Territory (including any active substance master file in the EMA) for API submitted or to be submitted by a Party to Regulatory Authorities.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • 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.

  • Clinical Studies means human clinical trials for a Licensed Product and any other tests and studies for a Licensed Product in human subjects.

  • Investigational Product means the Study Drug identified above and the control material, as further detailed in the Protocol;

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.