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

  • Each party shall promptly notify the other party in writing of any material communication or correspondence received from any Regulatory Authority relating to any Product or Regulatory Filings and Approvals, and shall provide the other party with copies of any such material communication or correspondence or with a written description of any oral material communication.

  • 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.

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

  • 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.

  • 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.

  • 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.

  • The Parties will use good faith efforts to cooperate to effectuate this Section 3.6(a) (Regulatory Filings and Approvals), and if, after the Parties’ use of good faith efforts, Lian, or its Affiliate or Sublicensee [***].

  • The Parties will use good faith efforts to cooperate to effectuate this Section 3.7(a) (Regulatory Filings and Approvals), and if, after the Parties’ use of good faith efforts, Lian, or its Affiliate or Sublicensee [***].

  • To Parent’s knowledge, there are no facts with respect to any Relevant Person which, if known to any Governmental Entity, would, individually or in the aggregate, be reasonably be expected to prevent, result in a denial or otherwise materially delay any Regulatory Filings and Approvals set forth on Schedule 6.1(b).

  • 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.


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 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.” 3. License Agreement Article 2. Article 2 of the License Agreement shall be amended as follows: Section 2.1 1 of the License Agreement shall be amended and restated as follows:
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Regulatory Filings and Approvals means the regulatory approvals, authorizations, licenses, applications, rights of reference, permits, INDs, NDAs and other permissions held by the Seller relating primarily or exclusively to any Product or any Business, including those set forth on Schedule A.1(n), in each case issued by Governmental Entities to the Seller.
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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 shall have the meaning set forth in Section 3.1(b) .
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Related to Regulatory Filings and 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.

  • 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.

  • Approvals means all approvals, consents, authorisations, permissions, licences, resolutions, exemptions, registrations, filings, permits and rights from all government, regulatory and statutory entities and authorities;

  • 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.

  • 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: (a) general plan, general plan amendments, specific plans and specific plan amendments; (b) tentative and final subdivision and parcel maps; (c) conditional use permits and master plans; (d) zoning, zoning map amendments, and zoning text amendments; and, (e) grading and building permits.

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

  • 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;

  • Authorizations means all filings, recordings, and registrations with, and all validations or exemptions, approvals, orders, authorizations, consents, franchises, licenses, certificates, and permits from, any Governmental Authority.

  • Product Approvals 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 with respect to any action by a particular Person, any consent, finding of suitability, license, approval or other authorization required for such action by such Person from a Gaming Authority or under Gaming Laws.

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

  • 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, 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.

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

  • 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.

  • 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 Standard Body necessary for the 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).

  • Governmental Authorities means any nation, government, province, state, or any entity, authority or body exercising executive, legislative, judicial, regulatory or administrative functions of or pertaining to government, including any government authority, agency, department, board, commission or instrumentality of any government or any political subdivision thereof, court, tribunal, arbitrator, the governing body of any securities exchange, and self-regulatory organization, in each case having competent jurisdiction (with each of such Governmental Authorities being referred to as a “Governmental Authority”).