Regulatory Filings and Approvals definition

Regulatory Filings and Approvals means, with respect to any pharmaceutical product in any jurisdiction, any and all regulatory applications, filings, approvals, and associated correspondence required to develop, manufacture, market, sell, and import such product in, or into, any jurisdiction, and all approvals from any regulatory authority necessary for the sale of such product in a given jurisdiction in accordance with all Applicable Laws.
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Regulatory Filings and Approvals means any and all permits, licenses, approvals, designations and authorizations required by any Regulatory Authority in connection with the development, manufacturing, packaging, marketing, selling and/or use of a Product in any jurisdiction in or for the Territory, or otherwise issued by any Regulatory Authority with respect to any Product in any jurisdiction in the Territory, as well as any applications for any of the foregoing filed with any Regulatory Authority. The Regulatory Filings and Approvals include, without limitation, the Product NDA.
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Regulatory Filings and Approvals means, with respect to any OpenBiome Royalty Product in any jurisdiction, any and all regulatory applications, filings, approvals, and associated correspondence reasonably required to Develop, Manufacture, market, sell, import, otherwise Commercialize, and exploit such OpenBiome Royalty Product in, or into, any jurisdiction, including, for clarity, all Regulatory Approvals necessary for the sale of such OpenBiome Royalty Product in a given jurisdiction in accordance with all Applicable Laws.
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Examples of Regulatory Filings and Approvals in a sentence

  • To Citius’ knowledge, the Products, and all Licensed Intellectual Property and data and information included in the Citius Regulatory Filings and Approvals, have been developed in accordance with Applicable Law.

  • Licensee shall not amend, modify, withdraw or abandon any of the Regulatory Filings and Approvals, nor shall it authorize any Third Party to take any of the foregoing actions, unless agreed in writing in advance by Citius.

  • Citius shall not amend, modify, withdraw or abandon any of the Regulatory Filings and Approvals, nor shall it authorize any Third Party to take any of the foregoing actions, in a manner that would impair Licensee’s rights hereunder, unless agreed in writing in advance by Licensee.

  • Following such designation, the Regulatory Agent will be the sole point of contact with Regulatory Authorities with respect to all matters relating to the Regulatory Filings and Approvals.

  • Without limiting the foregoing, Citius reserves the right to use (and to permit Alpex to use in accordance with Section 2.2(b) and Section 8.6 of the Alpex Agreement) any and all Licensed Intellectual Property (including without limitation all data included in the Citius Regulatory Filings and Approvals), outside the Territory and, subject to the restrictions set forth in Section 2.3.2 and the exclusive license set forth in Section 2.1, in the Territory.

  • Within twenty (20) business days after the Effective Date, Citius shall designate Akrimax (in its capacity as Licensee’s distributor of the Product) (the “Regulatory Agent”) as Citius’s sole authorized agent for all communications with FDA and any other applicable Regulatory Authorities on all matters relative to the Citius Regulatory Filings and Approvals and/or the Product and take all steps that may be necessary to effectuate such designation.

  • In the event any data included in the Citius Regulatory Filings and Approvals is used in connection with the approval of one or more products for sale by Citius and/or Alpex outside the Territory or, subject to the restrictions set forth in Section 2.3.2, in connection with products other than the Products (each a “Citius Product”), Citius will promptly notify Licensee in writing of such use and of the approval of each Citius Product.

  • As of the Effective Date, all Citius Regulatory Filings and Approvals are valid and in full force and effect.

  • Licensee and/or its Affiliates shall solely own any Regulatory Filings and Approvals obtained by Licensee and/or its Affiliates during the Term required to commercialize the Product based on the Product’s status as a controlled substance, as well as any required state licenses.

  • As of the Effective Date, there is no proceeding pending or, to the knowledge of Citius, threatened, to revoke, suspend, or modify any of the Citius Regulatory Filings and Approvals.


More Definitions of Regulatory Filings and Approvals

Regulatory Filings and Approvals means the regulatory and other third party consents, approvals and filings listed on Schedule 5.5(a).
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Regulatory Filings and Approvals has the meaning set forth in the License Agreement.
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Regulatory Filings and Approvals means any and all permits, licenses, approvals, designations and authorizations (a) required by any Regulatory Authority as a prerequisite to the development, manufacturing, marketing, selling and/or use in the Territory of (i) a Product in the Exclusive Field of Use or (ii) an Allergan Product in the Non-Exclusive Field of Use, or (b) otherwise issued by any Regulatory Authority in the Territory with respect to any (i) Product in the Exclusive Field of Use or (ii) Allergan Product in the Non-Exclusive Field of Use, in each case, as well as any applications for any of the foregoing filed with any Regulatory Authority.”
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Regulatory Filings and Approvals shall have the meaning set forth in Section 3.1(b) .
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Related to Regulatory Filings and Approvals

  • 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.

  • 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.

  • Approvals means all licenses, permits, approvals, certificates and other authorizations granted or issued by any Governmental Authority for the matter or item in question.

  • 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.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to:

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

  • 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;

  • Authorizations means all licenses, permits and approvals required by any governmental or quasi-governmental agency, body or officer for the ownership, operation and use of the Property or any part thereof.

  • 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.

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

  • 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.

  • 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.

  • Governmental Approvals means all authorizations, consents, approvals, licenses and exemptions of, registrations and filings with, and reports to, all Governmental Authorities.

  • Gaming Approvals means any and all approvals, licenses, suitability determinations, and other actions by any Gaming Authority necessary for the ownership, development, construction, financing, management and operation of the Company, CEC, CAC and any of their respective Subsidiaries, assets, businesses and properties.

  • Required Governmental Approvals has the meaning set forth in Section 3.03.

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.

  • 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 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 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 Authorities means the Commissions and the Exchange;

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

  • Governmental Entities has the meaning ascribed to it in the Purchase Agreement.

  • 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;

  • Product Authorizations means any and all approvals, including applicable supplements, amendments, pre- and post-approvals, clearances, licenses, notifications, registrations, certifications or authorizations of any Governmental Authority, any Regulatory Agency necessary for the preclinical or clinical testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of a Product in any country or jurisdiction.

  • Necessary Authorizations means all approvals and licenses from, and all filings and registrations with, any governmental or other regulatory authority, including, without limiting the foregoing, the Licenses and all approvals, licenses, filings and registrations under the Communications Act, necessary in order to enable the Borrower and its Subsidiaries to own, construct, maintain, and operate communications tower facilities and to invest in other Persons who own, construct, maintain, manage and operate communications tower facilities.

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