Finished Drug Product definition

Finished Drug Product means any drug product containing API as an active ingredient in finished bulk form for the Development or Commercialization by a Party under this Agreement.
Finished Drug Product means a drug that is legally marketed under the federal food, drug, and cosmetic act and that is in finished dosage form.

Examples of Finished Drug Product in a sentence

  • Within [***] days from the Effective Date, the Parties will discuss and mutually agree through the CSC, on an initial manufacturing technology transition strategy to transition API and Finished Drug Product Manufacturing for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx to [***] as the case may be.

  • Subject to the terms and conditions of this Agreement, Akcea hereby grants Novartis, a worldwide, non-exclusive, sublicensable (but only by Novartis to a Novartis Affiliate or a CMO), royalty-free license under the Licensed Technology solely to conduct during the Option Period the manufacturing and manufacturing transition activities contemplated by this Section 1.3.2 to manufacture API and Finished Drug Product for AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx.

  • A period of time from the Effective Date until ten (10) years after the Finished Drug Product is launched in the Territory.

  • As between Amgen and Company, upon receipt of payment by Amgen from Company under Section 3.2 of the License Agreement, Company shall hold title to the Finished Drug Product.

  • During the Term and subject to the terms and conditions of this Supply Agreement, Amgen shall, or shall cause one or more of its Affiliates or Subcontractors to, perform the Services in accordance with cGMP for the purpose of Processing the Drug Substance for Company to produce and store Finished Drug Product.


More Definitions of Finished Drug Product

Finished Drug Product means Drug Substance that has been Processed by Amgen pursuant to this Supply Agreement and that meets the Specifications.
Finished Drug Product means the finished product formulation of a Licensed Product labeled and packaged in a form ready for administration.
Finished Drug Product means any medicinal product manufactured by Buyer and containing the Product, manufactured by [*], as an active ingredient. GMP (Good Manufacturing Practices or Current Good Manufacturing Practices): Shall mean Good Manufacturing Practices requirements from time to time promulgated by Regulatory Authority, including the practices set out in the Guidelines published as the Good Manufacturing Practices by the drug authority(ies) in the Territory, as amended from time to time, for the manufacture of pharmaceutical Products for sale in the Territory.
Finished Drug Product means the Drug Product finally labelled and packaged for end-user use, as required for a Trial or for Commercialization, as applicable.
Finished Drug Product means that term as defined in 21 CFR 207.1.
Finished Drug Product means any drug product containing API as an active pharmaceutical ingredient in finished bulk form.
Finished Drug Product means a drug legally marketed under the federal food, drug, and cosmetic act, 21 U.S.C. 321 et seq., that is in finished dosage form.