Final Drug Product definition

Final Drug Product means Drug Product in the ready-to-sell form provided that a marketing authorization has been obtained for such pharmaceutical product from the U.S. Food and Drug Administration (FDA) or any other competent regulatory authority in the world.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedBook a Demo

Final Drug Product. A finished dosage form, for example, tablet, capsule, solution, etc., that contains an active drug ingredient generally, but not necessarily, in association with inactive ingredients. The term also includes a finished dosage form that does not contain an active ingredient but is intended to be used as a placebo.

Final Drug Product or "FDP" shall mean PRODUCT packaged into its final dosage form (liquid or lyophilized product in vials).

Examples of Final Drug Product in a sentence

• The United States Government (USG) will purchase Investigational New Drug (IND) Final Drug Product (FDP), (manufactured under cGMP conditions and described in the IND application to be used in the Phase I clinical trial) and perform independent comparative testing of products from prospective Contractor(s) (as described in requirement 1) and conduct an analysis of the comparative testing results.

• Finished Final Drug Product must be ordered in full Batch quantities.

• Lifecore represents and warrants to Heron that Lifecore and/or its Affiliates currently has access to, and during the entire Term of this Agreement will make all Commercially Reasonable Efforts to maintain access to, sufficient supplies of Raw Materials, utilities, container/closure systems, packaging materials, labor, and all other items required to supply Finished Final Drug Product to Heron without interruption to cover the Forecasts agreed by the Parties.

• Prior to the start of each calendar quarter throughout the Term, Heron will deliver to Lifecore a rolling forecast of its anticipated purchases, in whole Batch increments, of Finished Final Drug Product (including quantity and desired delivery dates) by month for [*********], unless expressly provided for otherwise in this Agreement.

• All Prices exclude VAT, federal, state or local taxes which are properly attributable to the Finished Final Drug Product and which will be added to the Price or billed separately to Heron where Lifecore has the legal obligation to collect the taxes or fees, and all expenses related to shipping, insurance, handling, storage, and customs duties and fees.

• Heron will provide shipping instructions for Finished Final Drug Product.

• If the product is in packaging or at the Finished Final Drug Product stage, the Price will be [*********] of the Finished Final Drug Product price.

• However, that to the extent Lifecore’s compliance with Applicable Law in a country other than the United States and the European Union would require Lifecore to bear increased costs, quality assurance or regulatory burdens in connection with the Manufacturing of the Finished Final Drug Product, the parties will meet and discuss in good faith how to reasonably invoice Heron for these costs in accord with Exhibit B, before Lifecore becomes responsible for compliance with such Applicable Law.

• Notwithstanding the foregoing, Lifecore warrants that Heron will receive good and marketable title to Finished Final Drug Product, free and clear of all liens and encumbrances.

• Thereafter, throughout the remainder of the Term of this Agreement, Heron shall place orders with Lifecore and purchase, if Lifecore is able to produce, an amount approximating [*********] of Heron’s requirements for units of Finished Final Drug Product.

More Definitions of Final Drug Product

Final Drug Product or “FDP” means [*********].

Final Drug Product means the pharmaceutical product for which Regulatory Approval has been obtained, in finished form ready for commercial sale and distribution to, and use by, patients, incorporating the PRODUCT supplied by POLYPEPTIDE.

Final Drug Product means any form of the vaccine, which can be sold to the final market, and which may comprise, among others, primary or secondary container or formulation forms or components, water-for-injection to reconstitute the vaccine, user information leaflet, blister packaging, paper box and country-specific packaging identification features.