FDA Approvals definition

FDA Approvals has the meaning set forth in Section 7.42.
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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).
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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.
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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.

  • If at any point during the Term, Vendor fails to maintain the appropriate and required FDA Approval(s), 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.

  • 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.

  • 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.

  • 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.

  • 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”).

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

  • If not earlier terminated as provided in this Article 10, the term of this Agreement (the “Term”) shall commence on the Effective Date and expire seven (7) years after FDA Approvals are obtained for the marketing and sale of the Magnus Analyzer in the United States; provided, however, that this Agreement may be renewed for subsequent five (5) year terms upon mutual agreement of the Parties.

  • KNC shall have the responsibility for seeking the FDA Approvals (but not for CE Marking or for Approvals outside of the United States) on Spectranetics’ behalf and in Spectranetics’ name for the Products.

  • Phase V (FDA Approvals) During Phase V the Parties will cooperate to obtain all required approvals from the U.S. Food and Drug Administration ("FDA") upon mutually agreeable terms reflected in a definitive agreement to be negotiated in good faith by the Parties when appropriate; provided, however, neither Party has agreed to incur any expenses whatsoever in connection with Phase V.

Related to FDA 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.

  • 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.

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) 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:

  • Regulatory Approval means, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

  • 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.

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

  • Approvals means the permits, clearances, licenses and consents as are listed in Schedule 3 hereto and any other statutory approvals.

  • Gaming Approvals means all Permits and Approvals issued by any Gaming Authority or under Gaming Laws necessary for or relating to the conduct of gaming and related activities or the manufacture, distribution, service or sale of alcoholic beverages, the ownership or the operation, management and development of any gaming operations, and, in the case of the Company, including the ownership, operation, management and development of the business of the Company and its Subsidiaries, and, in the case of the Acquirors, including the ownership, operation, management and development of the business of the Acquirors and its Subsidiaries.

  • 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 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).

  • Required Governmental Approvals means the Company Required Governmental Approvals and the Parent 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, certifications, licenses and permits granted by, submitted to or filed with any Regulatory Agencies, including all Product Authorizations.

  • 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 Licensed 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 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.

  • 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 for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.