FDA Regulatory Approval definition

FDA Regulatory Approval means with respect to an indication for any Licensed Product, approval of the NDA for such Licensed Product for that indication and such FDA approvals as may be required for the manufacture of the Licensed Product and supply of the same for commercial sale and use.
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Examples of FDA Regulatory Approval in a sentence

  • Otsuka shall be solely responsible for, and shall have full control of, commercialization of the Licensed Products including, marketing and sales activities in the Territory and post FDA Regulatory Approval risk minimization action plans.

  • Subject to Orchestra’s exclusivity obligations set forth in Section 2.3 hereof, during the period beginning on the Effective Date and ending on the date of FDA Regulatory Approval of the Product in the Primary Field (the “ROFN Period”), Medtronic will have an exclusive right to negotiate with Orchestra for an exclusive or any other license to commercialize devices using BackBeat CNT Algorithms in the Secondary Field of Use (“Secondary Field License”).

  • The results proved positive in terms of product quality, and it was noted that oil consumption for the boiler was reduced significantly.

  • The JSC will meet at least once per Calendar Quarter until such time as FDA Regulatory Approval of the Product is achieved and thereafter the JSC will meet at least once per MDT Fiscal Year.

  • Notwithstanding anything in the preceding sentence, Knight shall only be prohibited from Promoting, marketing or selling a Competitive Product for a Subsequent Indication if there is FDA Regulatory Approval for such Subsequent Indication prior to such time as Knight begins to Promote, market or sell such Competitive Product.

  • Regulatory Milestone Payments Regulatory Milestone Payment US FDA Regulatory Approval $2,500,000.00 First EU Major Market Country Regulatory Approval $2,500,000.00‌3.3 Royalty Payments.

  • Subject to successful validation of the API Manufacturing process by Supplier, and subject to Purchaser receiving FDA Regulatory Approval for the Finished Drug Product, Purchaser shall purchase no less than [***] percent ([***]%) of its total purchases of API from Supplier for the three (3) year period commencing on the date of FDA Regulatory Approval of the Finished Drug Product.

  • For the avoidance of doubt, with respect to the 0.15mg/0.3ml strength of the Product, which, as of the Effective Date, has not received FDA Regulatory Approval, the Company will be responsible for the registration activities for such strength in the Territory with the objective of obtaining approval for such strength in the Territory.

  • The purpose of this Agreement is to establish a collaboration through which the Parties, collectively, shall manufacture Vaccine, conduct non-clinical and clinical trials, seek FDA Regulatory Approval and commercialize Vaccine in the United States in an expeditious manner.

  • FDA Regulatory Approval Process for VaccinesFood and Drug Administration is a federal agen- cy that oversees the safety, efficacy, and security of food safety, pharmaceutical drugs for humans and animals, vaccines, biological products, over- the-counter drugs, and nutritional supplements.

Related to FDA Regulatory Approval

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

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

  • 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).

  • NDA Approval means the Approval of an NDA by the FDA for a Product in 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 Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • 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.

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

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

  • 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.

  • 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.

  • 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 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).

  • 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.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval in a country, territory or possession.

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

  • Pricing Approval means any approval, agreement, determination, or decision establishing prices that can be charged to consumers for a pharmaceutical or biological product or that will be reimbursed by Governmental Authorities for a pharmaceutical or biological product, in each case, in a country where Governmental Authorities approve or determine pricing for pharmaceutical or biological products for reimbursement or otherwise.

  • MFDA means the Mutual Fund Dealers Association of Canada;

  • 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 Submissions means all applications, filings, dossiers and the like submitted to a Governmental Authority for the purpose of obtaining Regulatory Approval.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • 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.

  • ANDA means an Abbreviated New Drug Application filed with the FDA pursuant to its rules and regulations.

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