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 the extent that the customer, either himself or through third parties, initiates the removal of non-conformities without the prior consent of Springer in writing, Springer will be released from his liability.

  • Comparison of Shareholder Rights For a comparison of the rights of shareholders of Fiat and FCA please see “Comparison of Rights of Shareholders of Fiat and FCA.” Regulatory Filings and Approvals Necessary to Complete the Merger Other than the approval of the FCA common shares for listing on the NYSE, subject to the notice of issuance, no further regulatory filings or approvals will be required for the effectiveness of the Merger.

  • 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.

  • Each of the Regulatory Filings and Approvals set forth on Schedule 6.1(b) shall have been obtained and if obtained shall remain in full force and effect, and, with respect to such Regulatory Filings and Approvals, no such Regulatory Filing and Approval shall have resulted in the imposition of a Burdensome Condition.

  • 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 [***].

  • 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.

  • GeoVax will own and solely Control all Regulatory Filings and Approvals for all Licensed Products throughout the Territory for use in the Field.

  • 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.

  • 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.

  • In general, the Group receives 30% of the contract value as receipt in advance from customers when they sign the sale and purchase agreement and remaining 70% of the contract value would be received through the banks by releasing the mortgages to the customers in two to three months after the agreement signing date.


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 shall have the meaning set forth in Section 3.1(b) .
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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 has the meaning set forth in the License Agreement.
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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 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 the permits, clearances, licenses and consents as are listed in Schedule 3 hereto and any other statutory approvals.

  • 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, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • 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.

  • 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 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 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 With respect to each Facility, all licenses, permits, accreditations, authorizations and certifications from any Governmental Authority which are material to or required for (i) the operation of such Facility and any Capital Addition thereto for its Primary Intended Use in accordance with all applicable, material Legal Requirements, including, without limitation, material state facility licenses, certificates of need, permits, provider agreements and accreditations or certifications from Medicare and/or Medicaid, and (ii) for any other use conducted on the Leased Property of such Facility and any Capital Additions thereto as may be permitted from time to time hereunder in accordance with all applicable, material Legal Requirements.

  • 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, with respect to a Licensed Product for any particular indication in any particular jurisdiction, regulatory applications and submissions (and any supplements or amendments thereto), and any notifications, communications, correspondence, registrations, drug master files, Regulatory Approvals and/or other filings made to, received from or otherwise conducted with a Regulatory Authority, including BLAs and INDs, as applicable, that relate to such Licensed Product in such jurisdiction. Regulatory Materials also include presentations, responses, and applications for Regulatory Approvals.

  • 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.

  • 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 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).