Transferred Regulatory Approvals definition

Transferred Regulatory Approvals means the pending and approved marketing authorizations relating to the Intermittent Testing Business and other applications for governmental regulatory approvals relating to the Intermittent Testing Business and all federal, state and local device establishment registrations and device listings, as listed on Schedule 1.1(c), part A, all foreign equivalents of the foregoing, including, but not limited to, those listed on Schedule 1.1(c), part B, and all documentary support for all the foregoing authorizations, approvals, registrations and applications.
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Transferred Regulatory Approvals means the Regulatory Approvals listed in Schedule G, in each case, in the form currently maintained by Seller (e.g., electronic).
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Transferred Regulatory Approvals means the pending and/or granted approvals and registrations that are owned or controlled by the Seller as of the Closing for the investigation, manufacture, distribution, sale and/or marketing of any Product (including without limitation any pending and/or cleared 510(k) notifications or pre-marketing approvals (PMAs)) and can be transferred to Buyer in accordance with the terms of this Agreement under applicable law, including without limitation those items set forth on Schedule 2.1, and all supplements and amendments thereto; and (ii) all dossiers, reports, data and other written materials filed as part of such approvals or registrations, or maintained by the Seller or its contractors and relating to such approvals or registrations.
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Examples of Transferred Regulatory Approvals in a sentence

  • The total amount allowed as security depends on whether the rental unit is unfurnished or furnished and whether the tenant has a waterbed.

  • To the extent practicable in the circumstances and subject to applicable laws or existing confidentiality agreements, the Seller will provide the Purchaser with the opportunity to review any information relating to such party, or any of its Affiliates, which appears in any filing made with, or written materials submitted to, any Governmental Entity or any non-governmental person in connection with obtaining the Requisite Governmental Approvals, or with respect to the Transferred Regulatory Approvals.

  • All Requisite Governmental Approvals will have been obtained and will remain in full force and effect, except for the Transferred Regulatory Approvals, as to which the Purchaser will have submitted all documentation necessary on its part to be submitted requesting transfer thereof.

  • Without limiting the generality of the foregoing, each Party will promptly notify the FDA of the transfer of the Transferred Regulatory Approvals to Buyer in a form reasonably acceptable to Buyer, and Seller cooperate with Buyer to ensure ongoing regulatory compliance pending FDA recognition of the transfer, including providing reasonable correspondence to the FDA at the reasonable request of Buyer.

  • Buyer shall use commercially reasonable efforts to assist Seller in the transfer of the Transferred Regulatory Approvals, accept the transfer of such Transferred Regulatory Approvals and formalize with Seller and any applicable Regulatory Authority, as promptly as practicable after the Closing Date, all necessary documents related thereto.

  • A dying peasant pours out his soul to him and is deeply grateful for having avoided damnation.

  • When licenses were issued to 11 payments banks of India in 2015, it was expected that the introduction of new players in the financial space would help advance digital financial services.

  • All regulatory approvals required to consummate the transactions contemplated hereby shall have been obtained and shall remain in full force and effect, except for the Transferred Regulatory Approvals, as to which the Purchaser shall have submitted all documentation necessary on its part to be submitted requesting transfer thereof.


More Definitions of Transferred Regulatory Approvals

Transferred Regulatory Approvals means those Regulatory Approvals listed on Schedule 1.84 . EAST\200870719.16
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Transferred Regulatory Approvals means the Permits of Seller or any of its subsidiaries with respect to the Product that are listed on Schedule 8.17(b)-2.
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Transferred Regulatory Approvals means the pending and approved marketing authorizations relating to the Western Blot Products and other applications for governmental regulatory approvals and approvals relating to the Western Blot Products and all Federal, state and local device establishment registrations and device listings, as listed on Schedule 1.1(c), part A, all foreign equivalents of the foregoing, including , but not limited to, those listed on Schedule 1.1(c), part B, and all documentary support for all the foregoing authorizations, approvals, registrations and applications.
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Related to Transferred Regulatory Approvals

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

  • 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;

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

  • 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.

  • 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.

  • 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).

  • 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 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.

  • 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:

  • 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).

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

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • 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.

  • 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.

  • 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).

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • Pricing Approval means such mandatory governmental approval, agreement, determination or decision establishing prices for the Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • 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.

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

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

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

  • 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 Authorities means the Commissions and the Exchange;

  • 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.