PRC Regulatory Filings definition

PRC Regulatory Filings means (i) the filing by the Purchaser or its applicable Affiliate of an overseas investment registration with the NDRC in respect of the transactions contemplated hereby, and the receipt by the Purchaser or its applicable Affiliate of a written acknowledgement issued by the NDRC that such registration has been completed; (ii) the filing by the Purchaser or its applicable Affiliate of an outbound investment registration with the Shandong Provision branch of MOFCOM in respect of the transactions contemplated hereby; and (iii) after completion of the procedures contemplated by subsections (i) and (ii) above, the registration by the Purchaser with SAFE or SAFE Designated Bank in respect of the transactions contemplated hereby.
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PRC Regulatory Filings means (i) the filing by the Purchaser or its applicable Affiliate of an overseas investment registration with the NDRC in respect of the
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PRC Regulatory Filings means, collectively, filings, permits, authorizations, consents and approvals as may be required under any applicable PRC Laws.
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Examples of PRC Regulatory Filings in a sentence

  • All PRC Regulatory Filings shall have been duly made or obtained, or the statutory clearance or non-objection period in respect thereof has expired and no objection has been raised with respect to the Transactions, in each case in accordance with applicable PRC Laws, and no Non-Required Remedy has been imposed with respect to any PRC Regulatory Filing.

  • All PRC Regulatory Filings shall have been duly completed, obtained and remain effective and legally valid.

  • The Parties shall reasonably cooperate with each other (including furnishing to each other all necessary information) in connection with the preparation and making of the PRC Regulatory Filings and resolving any investigation or other inquiry of any Governmental Authority in connection therewith.

  • The Purchaser shall have duly made all PRC Regulatory Filings and the Company shall have received copies of written evidence issued by the applicable Governmental Authorities showing that each PRC Regulatory Filing has been unconditionally confirmed or accepted, and all such confirmation or acceptance shall remain in full force and effect.

  • All Enumerated PRC Regulatory Filings shall have been made with, and unconditionally confirmed or accepted by, the applicable Governmental Authorities, and all such confirmation or acceptance shall remain in full force and effect.

  • The Seller shall, and shall cause each member of the Seller Group to, cooperate with the Purchaser (including furnishing to the Purchaser all necessary information) in connection with the preparation and making of the PRC Regulatory Filings and resolving any investigation or other inquiry of any Governmental Authority in connection therewith.

  • The Purchaser and the Seller shall complete all PRC Regulatory Filings that are required or contemplated to be performed or complied with respectively by the Purchaser and the Seller in accordance with the applicable Mainland China Laws (including the Purchaser submitting the CSRC Filing within three (3) Business Days following each Closing) and be responsible for resolving any investigation or other inquiry of any Governmental Authority in connection therewith.

  • The Purchaser shall, as soon as practicable after the Original Agreement Date, duly make all filings necessary under applicable PRC Laws (including, for the avoidance of doubt, the Enumerated PRC Regulatory Filings) in respect of the Offshore Investment and the transactions contemplated by the Transaction Documents (the “PRC Regulatory Filings”).

  • The Purchaser shall, as soon as practicable after the date hereof, duly make all filings necessary under applicable PRC Laws (including, for the avoidance of doubt, the Enumerated PRC Regulatory Filings) in respect of the Offshore Investment and the transactions contemplated by the Transaction Documents (the “PRC Regulatory Filings”).


More Definitions of PRC Regulatory Filings

PRC Regulatory Filings has the meaning set forth in Section 5.03;
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PRC Regulatory Filings means all filings necessary under the applicable Mainland China Laws (including, for the avoidance of doubt, the enumerated PRC Regulatory Filings) in respect of the Transactions;
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Related to PRC Regulatory Filings

  • Regulatory Filing means any approvals, licenses, registrations, submissions and authorizations, and applications therefor, including IND, NDA, BLA, drug dossier or drug master file filed, or Marketing Approval obtained, with respect to an Option Product, Licensed Product or Companion Diagnostic, as applicable, in the Field, including all amendments, supplements, annual reports and the like thereof or therefor filed with or otherwise provided to the applicable Regulatory Authority.

  • 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 Materials means regulatory applications, submissions, notifications, registrations, or other filings made to or with a Regulatory Authority that are necessary or reasonably desirable in order to develop, manufacture, market, sell or otherwise commercialize a product in a particular country or regulatory jurisdiction. Regulatory Materials include INDs, XXXx and NDAs (as applications, but not the approvals with respect thereto).

  • 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 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 an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • 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 Authorities means the Commissions and the Exchange;

  • 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 set out in Schedule C hereto;

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Regulatory Documentation means all applications, registrations, licenses, authorizations and approvals (including all Approvals), all correspondence submitted to or received from Regulatory Authorities (including minutes and official contact reports relating to any communications with any Regulatory Authority), all supporting documents and all Clinical Trials and tests, including the manufacturing batch records, relating to a Product, and all data contained in any of the foregoing, including all regulatory drug lists, advertising and promotion documents, adverse event files and complaint files.

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

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • 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 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.

  • 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, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

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

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • 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.

  • 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.

  • Study Data shall have the meaning set forth in Section 8.1.

  • Regulatory Authority means, with respect to any national, supra-national, regional, state or local regulatory jurisdiction, any agency, department, bureau, commission, council or other governmental entity involved in the granting of a Regulatory Approval for such jurisdiction.

  • 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;

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • FDA means the United States Food and Drug Administration.