Regulatory Filing definition
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 Filing means any filing with a Regulatory Agency relating to or to permit or request, as applicable, the clinical evaluation or Registration of a Licensed Product. Regulatory Filings include without limitation INDs and NDAs.
Regulatory Filing means any documentation comprising or relating to or supporting any filing or application with any Regulatory Authority with respect to the UHN Planned Trial, including any documents submitted to any Regulatory Authority and all supporting data, including CTAs and INDs, and all correspondence with any Regulatory Authority with respect to the UHN Planned Trial (including minutes of any meetings, telephone conferences or discussions with any Regulatory Authority).
Examples of Regulatory Filing in a sentence
The Regulatory Filing Fee must be paid in full before the Broker-Dealer submits the filing to FINRA.
Once the filing is confirmed in the FINRA portal, the Broker-Dealer will notify the Issuer of the exact fee owed to FINRA (the "Regulatory Filing Fee").
For clarity, Licensed Know-How shall include all material preclinical study reports that was generated by or on behalf of Hengrui or its Affiliates prior to the Effective Date, for any Licensed Compound or Licensed Product or incorporated (including any Data therein) in any Regulatory Filing for any Licensed Compound or Licensed Product.
The Issuer will pay the Regulatory Filing Fee to the Broker-Dealer, who will then forward the payment to FINRA.
More Definitions of Regulatory Filing
Regulatory Filing means any filing, application or submission for Regulatory Approval, and any notification and other correspondence made to or with a Regulatory Authority in connection with a Regulatory Approval, in each case that are necessary or reasonably desirable in Development, Manufacture or Commercialization in a particular country, whether submitted before or after a Marketing Approval in the country, including a PMA, a 510(k), or any other pre-market notification of intent, including any Regulatory Approvals, in each case with respect to a Product.
Regulatory Filing means all approvals, licenses, registrations, submissions and authorizations made to or received from a Regulatory Authority in a country necessary for the Development, manufacture and/or commercialization of a pharmaceutical product in the Territory, including any INDs, BLAs, Marketing Approval Applications and Marketing Approvals.
Regulatory Filing means an NDA, IND, or any foreign counterparts thereof, and any other filings required by regulatory authorities relating to the Development, manufacture, or Commercialization of any Licensed Product.
Regulatory Filing means, with respect to the United States, an NDA, BLA, or IND, any foreign counterparts or equivalents of any of the foregoing, any DMFs, and any other filings or submissions required by or provided to Regulatory Authorities relating to the manufacture, Development or Commercialization of any Product, including any supporting documentation, data, correspondence, meeting minutes, amendments, supplements, registrations, licenses, regulatory drug lists, advertising and promotion documents, adverse event files, complaint files, and manufacturing, shipping, or storage records with respect to any of the foregoing.
Regulatory Filing means any submission to a Regulatory Authority, including all applications, registrations, licenses, authorizations and approvals (including Regulatory Approvals), together with any related correspondence and documentation submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority) and all supporting documents and all clinical studies and tests, relating to a product and all data contained in any of the foregoing, including all INDs, Drug Approval Applications, regulatory drug lists, advertising and promotion documents, Clinical Data, adverse event files and complaint files, and include any submission to a regulatory advisory board, marketing authorization application, and any supplement or amendment thereto.
Regulatory Filing means any filing or application with any Regulatory Authority, including XXXx and authorization, approvals or clearances arising from the foregoing, including Marketing Approvals, and all correspondence with the FDA or other relevant Regulatory Authority, as well as minutes of any material meetings, telephone conferences or discussions with the FDA or other relevant Regulatory Authority, in each case with respect to Product.
Regulatory Filing means any New Drug Application or Abbreviated New Drug Application, or any other application, notification or submission made to or with the FDA or other regulatory authority for Registration of a human pharmaceutical product, together with all amendments and supplements to any of the foregoing.