Application for Regulatory Approval definition

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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Application for Regulatory Approval means each application accepted for filing submitted to a Regulatory Authority to obtain Regulatory Approval in the Territory.
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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.

  • DepoMed also shall be available, at the reasonable request of BLI, for consultation during any regulatory inspection or to assist in responding to regulatory questions that may occur during the prosecution of any Application for Regulatory Approval of the Licensed Product.

  • 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.

  • NaPro shall fund the first Twenty Million Dollars ($20,000,000) of Development Costs associated with performance of the activities set forth in the Development Plan including, but not limited to, clinical and pre- clinical activities in support of the Application for Regulatory Approval to commercialize a Finished Product.

  • ENDO, in its sole discretion, shall determine the form and contents of the Application for Regulatory Approval.

  • 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.

  • APPROVAL 5.1 APP shall provide to RHEI additional information relating to the Licensed Product in its possession or control that is required to support Application for Regulatory Approval of Licensed Product in the United States that may be reasonably necessary to enable RHEI to apply for and obtain Regulatory Approval in the Territory for the Licensed Product and to Market Licensed Product in the Territory.

  • Subject only to Section 20.4, BLI, or its Affiliate or sub-licensee, shall retain ownership of each Application for Regulatory Approval in the Territory, and all associated files and data and information relating to the Licensed Product, except for any Site Reference Files relating to the Licensed Product prepared by or for DepoMed.

  • 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.


More Definitions of Application for Regulatory Approval

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 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 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 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 any and all approvals (including price and reimbursement approvals, if required prior to sale in the applicable jurisdiction), licenses, registrations, or authorizations of any country, federal, supranational, state or local regulatory agency, department, bureau or other government entity that are necessary for the manufacture, use, storage, import, transport and/or sale of a particular Licensed Product in the applicable jurisdiction.

  • 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.

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

  • 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.