Initial Product NDA definition

Initial Product NDA means NDA22529.
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Examples of Initial Product NDA in a sentence

  • Unless and until agreed otherwise, Arena (or one of its Affiliates) shall remain responsible for safety reporting for any clinical trials of the Initial Product for the Territory until the transfer of the Initial Product NDA to Eisai under Section 3.10(a), at which time Eisai shall become responsible therefor.

  • The Manufacturing Working Group shall work in good faith to use Commercially Reasonable Efforts to maximize the shelf life of all Initial Product delivered to Eisai from the date of FDA approval of the Initial Product NDA to the end of the third month after the First Commercial Sale of the Initial Product in the United States.

  • Upon FDA approval of the Initial Product NDA, Arena shall cause Arena US to transfer the Initial Product NDA to Eisai and to provide to the FDA (with a copy to Eisai) a letter indicating that ownership and a copy of all applicable documents with respect to the Initial Product NDA have been transferred to Eisai pursuant to 21 C.F.R. 314.72.

  • Arena shall thereafter use diligent efforts to provide Eisai a copy of the applicable documents, and Eisai shall use diligent efforts to provide to the FDA commitments to all applicable regulatory requirements relevant to the Initial Product NDA pursuant to the applicable regulations.

  • Arena US has filed the Initial Product NDA with the FDA, and Arena has conducted (or caused Arena US to conduct), the regulatory activities with respect to the FDA for the Initial Product through achievement of initial Regulatory Approval in the United States for the Initial Product (resulting in the approved Initial Product NDA).

  • For clarity, development of the Initial Formulation for Indications other than the Indications that, as of the 2nd Amendment Effective Date, are the subject of the Initial Product NDA shall not be considered Non-Required U.S. Development and shall instead be considered development of an Additional Product under Section 3.3.

  • The area of the building is expected to be approximately 14,257 square metres.Income support provisionsThe Vendor has agreed to pay a sub trust of the Fund any shortfall in rental income to the extent that in a particular month the Fund receives rental income from premises which are unlet at Completion which is less than if those premises had been let out at the rates set out in the 2006 Jones Lang LaSalle valuation.

  • Unless and until agreed otherwise, Arena (or one of its Affiliates) shall remain responsible for safety reporting for any clinical trials of the Initial Product for the United States until the transfer of the Initial Product NDA to Eisai under Section 3.10(a), at which time Eisai shall become responsible therefor, and Eisai shall be responsible for safety reporting for any clinical trials of the Initial Product for countries in the Additional Territory.

  • Arena US has filed the Initial Product NDA with the FDA, and Arena shall be responsible (as provided in Section 3.10(a)) for conducting, or causing Arena US to conduct, the regulatory activities with respect to the FDA for the Initial Product through achievement of initial Regulatory Approval in the United States for the Initial Product.

  • For clarity, development of the Initial Formulation for Indications other than the Indications that, as of the 2nd Amendment Effective Date, are the subject of the Initial Product NDA shall not be considered Non-Required Additional Territory Development and shall instead be considered development of an Additional Product under Section 3.3.

Related to Initial Product NDA

  • Commercial Product means any such product as defined in FAR 2.101.

  • Final Product means a reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Phase 4 Clinical Trial means a Clinical Trial of a Product conducted after Regulatory Approval of such Product has been obtained from an appropriate Regulatory Authority, which trial is (a) conducted voluntarily by a Party to enhance marketing or scientific knowledge of the Product, or (b) conducted due to a request or requirement of a Regulatory Authority.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • Approved Product means any water fitting, plumbing product, material or component which is the subject of an existing WRAS Approval;

  • Therapeutic Product means a health product categorised as a therapeutic product in the First Schedule to the Act;

  • Aerosol Product means a pressurized spray system that dispenses product ingredients by means of a propellant contained in a product or a product's container, or by means of a mechanically induced force. “Aerosol Product” does not include “Pump Spray.”

  • Collaboration Product means a pharmaceutical product containing or comprising Compound in any dosage form alone, or in combination with, one or more other pharmaceutically active ingredients, and any and all Improvements thereto.

  • Phase I Clinical Trial means a human clinical trial that is intended to initially evaluate the safety and/or pharmacological effect of a Product in subjects or that would otherwise satisfy requirements of 21 C.F.R. 312.21(a), or its foreign equivalent.

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • 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.

  • Existing Product means any formulation of the same product category and form sold, supplied, manufactured, or offered for sale in California prior to the following dates, or any subsequently introduced identical formulation:

  • Approved clinical trial means a phase I, phase II, phase III, or phase IV clinical trial that is conducted in relation to the prevention, detection, or treatment of cancer or other life-threatening disease or Condition and is described in any of the following:

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • New Product means the Synology-branded hardware product and Synology-branded accessories contained in the original packaging Customer bought from an authorized Synology distributor or reseller. You may see our “New Product” at Product Support Status.

  • Tobacco product manufacturer means an entity that after the date of enactment of this Act directly (and not exclusively through any affiliate):

  • ANDA means Abbreviated New Drug Application.

  • Licensed Product means a product or part of a product in the Licensed Field of Use: (A) the making, using, importing or selling of which, absent this license, infringes, induces infringement, or contributes to infringement of a Licensed Patent; or (B) which is made with, uses or incorporates any Technology.

  • New Products means any product which is not an Enhanced Product or 2 Existing Product but which is substantially similar to an Existing Product with respect to design and function and possesses reasonable performance improvements. If Company desires to purchase an Enhanced or New Product(s) from Supplier, Company shall so notify Supplier and provide Supplier the opportunity to manufacture such Enhanced or New Product(s), subject to the following conditions and procedures.

  • Phase III Clinical Trials means a Clinical Trial for the Product on sufficient numbers of patients to generate safety and efficacy data to support Regulatory Approval in the proposed therapeutic indication, conducted in accordance with current good clinical practices and in accordance with a protocol that has been reviewed by the FDA and reflects any comments or concerns raised by the same.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Phase IV Clinical Trial means a product support clinical trial of a Product commenced after receipt of Regulatory Approval in the country where such trial is conducted. A Phase IV Clinical Trial may include epidemiological studies, modeling and pharmacoeconomic studies, and investigator-sponsored clinical trials studying Product that are approved by the JDC and that otherwise fit the foregoing definition.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, protein other than a chemically synthesized polypeptide, or analogous product, or arsphenamine or any derivative of arsphenamine or any other trivalent organic arsenic compound, applicable to the prevention, treatment, or cure of a disease or condition of human beings.

  • Phase IIb Clinical Trial means a clinical trial of a Product on sufficient numbers of patients that is designed to provide a preliminary determination of safety and efficacy of such Product in the target patient population over a range of doses and dose regimens.