United States Regulatory Approval definition

United States Regulatory Approval means final approval from the FDA to Commercially Manufacture, use and Distribute Product for Permitted Clinical Applications within the United States.
Sample 1Sample 2Sample 3
United States Regulatory Approval means Regulatory Approval in the United States of America.
Sample 1Sample 2
United States Regulatory Approval means approval by the FDA or any successor entity of an NDA or other applicable filing and satisfaction of any related applicable FDA registration and notification requirements (if any), together with any pricing approvals and labeling approvals.
Sample 1

Examples of United States Regulatory Approval in a sentence

  • If, after October 1, 2017 CryoLife has not received United States Regulatory Approval, SMI may by written notice require CryoLife to terminate CryoLife’s exclusive right and license to apply for, pursue and maintain United States Regulatory Approval for Products described in Section 5.2. In such event, both Parties agree to negotiate in good faith to make commercially reasonable modifications to this Agreement.

  • CryoLife shall have the exclusive right and license to apply for, pursue and maintain United States Regulatory Approval for Products and SMI and CryoLife shall have the mutually exclusive right and license to pursue obtaining Regulatory Approval for Products outside of the United States and Canada within the Territory.

  • SMI will provide assistance to CryoLife in support of its efforts to obtain Regulatory Approval in Canada in the same manner and to the same extent as it provides assistance with respect to United States Regulatory Approval pursuant to Sections 5.2 and 5.3.

  • United States Regulatory Approval, once obtained, shall be in the name of and owned by CryoLife.

  • SMI shall provide reasonable assistance to CryoLife in its efforts to obtain United States Regulatory Approval.

  • CryoLife shall have exclusive responsibility for all communications, submissions and interactions with FDA and other Regulatory Authorities for the purpose of obtaining and maintaining United States Regulatory Approval.

  • Once CryoLife has obtained United States Regulatory Approval for the Products, CryoLife will be responsible for all marketing support and related costs for Products it Manufactures.

  • CryoLife will use reasonable efforts to design, fund, and conduct a program intended to gain required United States Regulatory Approval (the “Regulatory Approval Program”).

  • Upon receipt of United States Regulatory Approval for a Selected Natural Sweetener Compound or Selected Analog Compound, the compound can be offered by SENOMYX in the Exclusive Product Categories to any Third Party, including Third Parties that have not funded SENOMYX research.

  • Upon receipt of United States Regulatory Approval for a Selected Natural Enhancing Compound, the compound can be offered by SENOMYX to any Third Party in the Exclusive Product Categories, including Third Parties that have not funded research of SENOMYX.

Related to United States Regulatory Approval

  • 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.

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

  • 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;

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

  • Customs territory of the United States means the 50 States, the District of Columbia, and Puerto Rico.

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

  • 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.

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

  • FDA means the United States Food and Drug Administration and any successor agency thereto.

  • 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 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.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Foreign Financial Regulatory Authority shall have the meaning given by Section 2(a)(50) of the 0000 Xxx.

  • 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.

  • Securities Regulatory Authorities means the securities commission or similar regulatory authority in each province and territory of Canada that is responsible for administering the Canadian securities legislation in force in such jurisdictions;

  • 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.

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

  • Canadian Securities Regulatory Authorities means the securities regulatory authorities in each of the provinces and territories of Canada;

  • CFDA means the Code of Federal Domestic Assistance assigned to a federal grant.

  • NDA means a New Drug Application, as defined in the regulations promulgated by the United States Food and Drug Administration, or any foreign equivalent thereof.

  • Biologics License Application or “BLA” means an application requesting permission from the FDA to introduce, or deliver for introduction, a biological product into interstate commerce, or any similar application or submission for marketing authorization of a product filed with a Regulatory Authority to obtain Regulatory Approval for such product in a country or group of countries.

  • 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).

  • foreign regulatory authority means a securities commission, exchange or other securities market regulatory authority in a designated foreign jurisdiction;

  • New Drug Application means a new drug application in the United States for authorization to market a product, as defined in the applicable laws and regulations and submitted to the FDA.