Application for Regulatory Approval definition

Application for Regulatory Approval means each application in a form accepted for filing by a Regulatory Authority to obtain Regulatory Approval in the Territory.
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Application for Regulatory Approval means an application made to a Regulatory Authority in any country for permission to Market a pharmaceutical product in that country.
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Application for Regulatory Approval means an application made to a Regulatory Authority in any country for permission to Market a pharmaceutical product in that country, and includes a New Drug Application (an “NDA”) and an Abbreviated New Drug Application (an “ANDA”).
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Examples of Application for Regulatory Approval in a sentence

  • DepoMed shall not be responsible for any deficiencies or defects in any studies conducted by a contract research organization designated by BLI pursuant to this section, or for any delays in the filing of an Application for Regulatory Approval caused by or arising from the use of any such contract research organization.

  • Upon the fulfillment of the obligations contained in clauses (i) and (ii) above, the Lessor shall transfer to the Lessee all of its right, title and interest in and to the Property (to the extent not previously transferred to the Lessee in accordance with the Lease) and any amounts or proceeds referred to in the foregoing clause (b) shall be paid over to the Lessee.

  • NaPro shall have sole ownership of its DMF related to the manufacture and control of Bulk Drug submitted in support of any Application for Regulatory Approval.

  • For capacity planning purposes, upon first submission of an Application for Regulatory Approval to a Regulatory Authority, Durata shall provide Hospira with a non-binding, written forecast of Durata’s annual requirements of Product for the following [**] (the “Annual Forecast”).

  • In general, Abbott shall be responsible for xxx xxllowing: (a) finishing the Bulk Xxxx into a finished dosage form for patient administration as a Finished Product for Commercial Use; (b) reviewing, preparing, with input from NaPro, and filing the Applications for Regulatory Approval as holder of the NDA or equivalent; and (e) maintaining the Application for Regulatory Approval.

  • BLI shall provide to Polymer regular reports in respect of each such Application for Regulatory Approval undertaken by BLI.

  • Under the Project, Hospira shall assist Durata to develop the Product and to obtain any required Application for Regulatory Approval in the various countries where Durata intends to market, promote and sell the Product.

  • ANX-514 manufactured from anhydrous docetaxel will be the initial Product for which a New Drug Application for Regulatory Approval in the United States is submitted.

  • APP shall reasonably cooperate with RHEI in the filing of an Application for Regulatory Approval in the Territory.

  • Durata and Hospira desire that Hospira assist Durata in the development and commercialization of Dalbavancin; and WHEREAs, after Durata has filed an Application for Regulatory Approval (as defined below) from relevant Regulatory Authorities (as defined below), the Parties desire that Hospira manufacture and sell to Durata a finished dosage form of Dalbavancin as set forth in this Agreement.


More Definitions of Application for Regulatory Approval

Application for Regulatory Approval means a submission made to the FDA (whether such application be in the form of an NDA, ANDA, sNDA or other similar application) or the appropriate regulatory body equivalent to the FDA in a country other than the United States in the Territory, seeking approval to market and sell a Finished Product in either the United States or such other country, respectively. "Applicable Percentages" shall have the meanings variously ascribed thereto in Sections 4.1, 4.2, and 4.3. "Approval Date" shall mean the date on which the FDA or the appropriate regulatory body equivalent to the FDA in a country in the Territory other than the United
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Application for Regulatory Approval means an application made to a Regulatory Authority for permission to Market and/or Manufacture the Product in any country in which that Regulatory Authority has jurisdiction.
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Application for Regulatory Approval means an application made to a Regulatory Authority in any country for permission to Market Licensed Product in that country, and includes without limitation a New Drug Application (an "NDA") and an Abbreviated New Drug Application (an "ANDA") submitted to the FDA or an equivalent application submitted to an equivalent Regulatory Authority in the Territory.
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Application for Regulatory Approval means any application required for the purpose of marketing or selling or using a therapeutic or prophylactic product to be filed with a governmental agency in any jurisdiction, including a New Drug Application (“NDA”) filed with the FDA or Product License Application or Marketing Authorization in the European Union.
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Application for Regulatory Approval means the foreign equivalent to an NDA in Countries of the Territory other than the United States.
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Application for Regulatory Approval shall have the meaning given it in the Development Agreement. "Business Day" means any day except a Saturday, Sunday or other day on which commercial banks in the City of Chicago are authorized by law to close. "Change in Control" shall mean a merger of NaPro with or into, or the sale of all or substantially all of the assets of NaPro to, any company the equity market capitalization of which is at least fifteen billion dollars ($15,000,000,000) and that is engaged primarily in the manufacture, distribution or sale of pharmaceutical or health care products. "Common Stock" shall have the meaning set forth in the Recitals to this Agreement. "Control" and the correlative terms "Controlling" and "Controlled" shall mean the power, whether or not exercised, directly or indirectly to direct the management and policies of a Person whether by contract, through the ownership of voting securities or otherwise. "Development Agreement" shall have the meaning set forth in the Recitals to this Agreement. EXECUTION COPY
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Related to Application for Regulatory Approval

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or 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.

  • Marketing Authorization Application or “MAA” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.

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

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

  • 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.

  • 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.

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

  • 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.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • 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.

  • BLA means a Biologics License Application under the United States’ Public Health Services Act and Federal Food, Drug and Cosmetics Act, each as amended, and the regulations promulgated thereunder, or a comparable filing seeking Regulatory Approval in any country.

  • 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.