First New Product FDA Approval definition

First New Product FDA Approval means the date upon which final approval is received from the United States Food and Drug Administration with respect to the first New Product (immediately following which such New Product may be manufactured and commercially sold in the United States).
Sample 1Sample 2Sample 3
First New Product FDA Approval means the date upon which the first approval is received from the United States Food and Drug Administration with respect to the first New Product (immediately following which such New Product may be manufactured and commercially sold in the United States).
Sample 1

Examples of First New Product FDA Approval in a sentence

  • With regard to Licensed Products, including without limitation, C2B8, for each calendar year or portion thereof prior to the First New Product FDA Approval, IDEC and Genentech shall receive 30% and 70%, respectively, of the first $50 million in Operating Profits (calculated solely with respect to Licensed Products) and 40% and 60%, respectively, of Operating Profits (calculated solely with respect to Licensed Products) in excess of $50 million.

  • With regard to New Products (including without limitation G2H7), prior to the First New Product FDA Approval, in each calendar year IDEC and Genentech shall pay 30% and 70% respectively, of all Operating Losses (calculated solely with respect to New Products).

Related to First New Product FDA Approval

  • 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.

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

  • 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.

  • 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.

  • 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.

  • 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 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).

  • 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.

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

  • 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.

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

  • 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.

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

  • ANDA means Abbreviated New Drug Application.

  • 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.

  • Non-Microsoft Product means any third-party-branded software, data, service, website or product, unless incorporated by Microsoft in a Product.

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

  • Hemp product means the same as that term is defined in § 3.2-4112.

  • 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.

  • 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.

  • 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.”

  • 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).

  • Licensed Territory means worldwide.

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

  • 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.