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 those Regulatory Approvals listed on Schedule 1.84 . EAST\200870719.16
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Examples of Transferred Regulatory Approvals in a sentence

  • 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.

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

  • 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.

  • The Seller shall use its commercially reasonable efforts to have the Purchaser participate (with such participation by Purchaser to be limited to listening) in any calls with Governmental Authorities relating to or otherwise in respect of the Transferred Product Regulatory Documentation or Transferred Regulatory Approvals.

  • 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.

  • 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.

  • For clarity, the Seller shall have final decision-making authority regarding the contents of any submission or transmission to any Governmental Authority in respect of the Transferred Product Regulatory Documentation or Transferred Regulatory Approvals pursuant to this Section 6.5.2.

  • 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.

  • 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 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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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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Related to Transferred Regulatory Approvals

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

  • 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).

  • 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.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

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

  • 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: (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.

  • 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.

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

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • 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, 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.

  • 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 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.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed 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, including all INDs and NDAs.

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

  • 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.

  • Regulatory Authorities means the Commissions and the Exchange;

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.