We use cookies on our site to analyze traffic, enhance your experience, and provide you with tailored content.

For more information visit our privacy policy.

FDA Approvals definition

FDA Approvals shall have the meaning ascribed to such term in Section 3.1(oo). “GAAP” shall have the meaning ascribed to such term in Section 3.1(h). “GM” means Grushko & Mxxxxxx, P.C., with offices located at 500 Xxxxxxxx Xxxxxx, Xxxxxx Xxxxxx, Xxx Xxxx 00000. “Harvard Trials” shall have the meaning ascribed to such term in Section 3.1(oo). “Indebtedness” shall have the meaning ascribed to such term in Section 3.1(aa).
Sample 1Sample 2
FDA Approvals has the meaning set forth in Section 7.42.
Sample 1Sample 2
FDA Approvals means approvals obtained from the FDA, including without limitation, 510(k)s, NDAs and PMAs, necessary to the operation of the business of SDI as it relates to the Two Products.
Sample 1

Examples of FDA Approvals in a sentence

  • The Parties intend to establish this strategic collaboration for the design, development, marketing and support of the Magnus Analyzer and its subsystems, including obtaining the necessary Approvals for its use, sale and marketing, specifically FDA Approvals.

  • Vendor acknowledges that additional FDA approvals may need to be obtained in the future, in addition to the EUA FDA Approval(s) (collectively the “FDA Approvals”).

  • FDA Approvals For Smart Algorithms In Medicine In One Giant Infographic -.

  • If Vendor fails to obtain the appropriate and required FDA Approval(s) prior to August 31, 2020, CVS, or its designated distributor on its behalf, as applicable, retains the right to return any purchased unused Products to Vendor and receive a full refund for any amounts paid to Vendor for such unused Products.

  • Licensee shall pay Cellegy a milestone payment of ten million dollars ($10,000,000) in cash no later than thirty (30) days after Cellegy certifies in writing to Licensee that the Licensed Product has all FDA Approvals required to promote, sell and distribute the Licensed Product in the United States.

  • The Company will make all Regulatory Filings and obtain and maintain all required Regulatory Approvals (including all required FDA Approvals) for the Products in the Designated Jurisdictions.

  • The Company agrees to use all commercially reasonable efforts to complete the Harvard Trials and the FDA Approvals.

  • Elan shall be responsible for the compilation and filing of the Regulatory Filings in respect of the Product with the FDA and shall be the holder of any FDA Approvals granted for the Product and the Party principally responsible for interaction with the FDA.

  • They were discovered using experimental setup, for exam- ple by using ambiguous sentences and asking participants to choose an interpretation:(1) Fred loves Pete, because he is always smiling.In (1), people could be asked who the pronoun he refers to, and most would answer Pete, whereas in fact both Fred and Pete are possible answers.

  • The obligations set forth in this Agreement are subject to Vendor obtaining and maintaining the appropriate FDA Approvals now and in the future for the LumiraDx Instrument and COVID-19 Test Strips as well as the ancillary equipment, including collection supplies (“Ancillary Equipment”) necessary to administer the tests (collectively the “Products”) that expressly authorizes use of the LumiraDx Instrument and COVID-19 Tests strips in patient care settings outside of the clinical laboratory environment.

Related to FDA 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.

  • 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.

  • 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.

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

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

  • 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;

  • 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.

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

  • 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 Approval means any and all approvals, licenses, registrations or authorizations of any Regulatory Authority that are necessary for the marketing and sale of a product in a country or group of countries.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the applicable country or jurisdiction, but excluding any Pricing and Reimbursement Approval.

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

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

  • 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.

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

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Licensed Product in any country (including without limitation all applicable Price Approvals even if not legally required to sell Licensed Product in a country).

  • Required Governmental Approvals means Purchaser Required Governmental Approvals and Seller Required Governmental Approvals.

  • 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.

  • Regulatory Authorizations means all approvals, clearances, notifications, authorizations, orders, exemptions, registrations, listings, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies necessary for the testing, manufacture, development, distribution, use, storage, import, export, transport, promotion, marketing, sale or other commercialization of any Product in any country or jurisdiction, including any Investigational Application.

  • 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.

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

  • 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.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • 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.

Most Referenced Clauses

Most Referenced Definitions