Government Regulatory Approvals definition

Government Regulatory Approvals means all government approvals, health registrations and/or permits required for manufacture, sale, and distribution of Product(s) in the Territory.
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Examples of Government Regulatory Approvals in a sentence

  • KI PHARMA and GRELAN also shall keep BIONUMERIK regularly and fully informed of the status of the Government Regulatory Approvals process on a current basis and furnish BIONUMERIK, upon BIONUMERIK's reasonable request, with English version copies of all important documents, data and other information supplied to or received from the Japanese Government or other approval authority in connection with the applications for the Government Regulatory Approvals.

  • In addition, both ASTA Medica and BioNumerik shall retain the right to use the Data and Results as provided in Section 6 and, in the event this Agreement is terminated pursuant to Section 14.2.1 (b), BioNumerik and its assignees and sublicensees may also use such Data and Results for the purpose of seeking further Government Regulatory Approvals in the Territory following such termination.

  • Subject to the terms of this Agreement, BioNumerik hereby grants to ASTA Medica and its Affiliates an exclusive license in the Territory under the BioNumerik Patent Rights, BioNumerik Know-How and BioNumerik Improvements to conduct and have conducted research and development (including studies and clinical trials) of the Product(s) in the Territory for the purpose of obtaining Government Regulatory Approvals in the Territory.

  • Effective as of the Effective Date, GRELAN hereby grants to KI PHARMA an exclusive license under the Grelan Patent Rights, Know-How and Grelan Improvements to conduct and have conducted research and development of the Venture Products GR in the Territory for the purpose of obtaining Government Regulatory Approvals in the Territory.

  • In connection therewith, ASTA Medica shall, at its own expense and in accordance with the priorities determined by the Alliance Steering Committee, apply for all health registrations and Government Regulatory Approvals required to execute and to perform this Agreement.

  • If the Government Regulatory Approvals are not permitted to be obtained by KI PHARMA in the name of KI PHARMA, then, with the consent of GRELAN and BIONUMERIK (which consent will not be unreasonably withheld) such approvals will be obtained in the name of GRELAN.

  • If permitted by laws in the Territory, the Government Regulatory Approvals for Venture Products shall be obtained in the name of KI PHARMA, and GRELAN shall provide such additional assistance as may be necessary to assure that such Approvals are obtained in the name of KI PHARMA.

  • Effective as of the Effective Date, BIONUMERIK hereby grants to KI PHARMA and GRELAN an exclusive license under the BioNumerik Patent Rights, Know-How and BioNumerik Improvements to conduct and have conducted research and development of the Venture Products BN in the Territory for the purpose of obtaining Government Regulatory Approvals in the Territory.

  • ASTA Medica shall keep BioNumerik regularly and fully informed of the status of the Government Regulatory Approvals process on a current basis and furnish BioNumerik upon BioNumerik's reasonable request with copies of all of the documents, data and other information supplied to or received from applicable government authorities in connection with the applications for the Government Regulatory Approvals.

  • Upon receipt of the Government Regulatory Approvals, ASTA Medica shall promptly furnish BioNumerik copies or other satisfactory evidence thereof.

Related to Government Regulatory Approvals

  • 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.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • 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;

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

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

  • 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.

  • Government Approval means any authorization, consent, approval, waiver, exception, variance, order, exemption, publication, filing, declaration, concession, grant, franchise, agreement, permission, permit, or license of, from or with any Governmental Authority, the giving notice to, or registration with, any Governmental Authority or any other action in respect of any Governmental Authority.

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

  • Government Authorities means, without limitation, all Government departments and agencies with responsibility for the import and export of goods, the collection of revenue on the import and export of goods and the transport of those goods to include, without limitation, Customs, AQIS, the ATO and the RSA;

  • 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.

  • 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.

  • Government Authorizations means all such approvals, consents, authorizations, acknowledgements, licenses or permits required to be issued by any Government Authority to the Company for the establishment of the Company or to the Company or the Contractors for the construction, financing, ownership, operation, and maintenance of the Facility by the Company or the Contractors, including, without limitation, those Government Authorizations listed in Schedule 1;

  • Regulatory Authorities means the Commissions and the Exchange;

  • 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.

  • 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).

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • 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.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • Insurance Regulatory Authority means, with respect to any Insurance Subsidiary, the insurance department or similar Governmental Authority charged with regulating insurance companies or insurance holding companies, in its jurisdiction of domicile and, to the extent that it has regulatory authority over such Insurance Subsidiary, in each other jurisdiction in which such Insurance Subsidiary conducts business or is licensed to conduct business.

  • 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.

  • Export Approvals has the meaning specified in Section 4.26(a).

  • 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.

  • 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.

  • Required Governmental Approvals means the Company Required Governmental Approvals and the Parent Required Governmental Approvals.