active substance definition
Examples of active substance in a sentence
All Naltrexone Hydrochloride supplied hereunder will be manufactured in accordance with the methods, processes and procedures, including site of manufacture, set forth in MALLINCKRODT’s drug master file (“DMF”) or any equivalent issued under any applicable laws, rules or regulations other than those of the United States (such as an Active Substance Master File or a Certificate of European Pharmacopeia, (such documents referred to as a “DMF Equivalent”) for Naltrexone Hydrochloride.
Upon Hapila's receipt of at least [***] notice from Biofrontera, Hapila will give employees or authorized representatives of Biofrontera, its Affiliates or License Partners for third countries access to any facilities and records related to the Manufacture of Product, including any facility and records of Hapila's subcontractors for the Product or Active Substance, in order to audit Hapila's compliance with the terms of this Agreement.
Notwithstanding the foregoing to the contrary, Mylan shall not have the right to manufacture (or have manufactured) Biological Active Substance.
Revance shall ensure that the facility(ies) in which the Biological Active Substance and, to the extent supplied by Revance or a Revance CMO (unless Mylan has elected to obtain supply from such Revance CMO pursuant to an agreement between Mylan and such Revance CMO), the Product is to be manufactured for use or sale in the Mylan Territory (the “Facility”) is/are in compliance with all Applicable Law, as of the Effective Date and during the term of the Supply Agreement.
The purpose of the payments provided for in Sections 3.4 and 3.5 is to provide Inhale customary, arm's-length compensation related to powder processing work performed by Inhale with respect to Designated Products, but not to provide Inhale compensation for its ownership of intellectual property covering the manufacture of a Powder Formulation of an Active Substance of a Designated Product ("Other Inhale Technology").