Drug Substances definition

Drug Substances means the active ingredient(s) in the respective Products, listed in Annex 3 attached hereto.
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Drug Substances has the meaning set forth in the Asset Purchase Agreement.
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Drug Substances or “BDS” means *** .
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Examples of Drug Substances in a sentence

  • The conditions meet the requirements of the International Conference for Harmonization, as described in Q1A(R2) “Stability Testing of New Drug Substances and Products”.

  • For the avoidance of doubt, the Drug Substances are non-proprietary and Novartis retains the right to make and use the Drug Substances in the Territory.

  • Subject to the exceptions contained in the Confidentiality Agreement, Purchaser (and its Affiliates or distributors) shall keep confidential and not disclose to any Third Party any confidential information pertaining to the Business and the Transferred Assets, which is received or obtained as a result of entering into or performing this Agreement, including, Know-How concerning the manufacture of the Drug Substances and Products.

  • Furthermore, Novartis is not responsible for conducting any studies, including clinical and stability studies, concerning the Drug Substances and/or the Products, which may be requested by the Regulatory Authority or any Governmental Authority after the Closing Date, regardless of whether the MA Transfer Date has occurred or not.

  • Purchaser shall, following the Closing Date, use commercially reasonable efforts in order to source the Products and the Drug Substances independently from Novartis, and in no event later than the end of the Transition Period.

  • As used in this Clause, “blinded” means neither Customer nor Drug Substances, Drug Product, Product, Customer Materials, Customer Information, Customer Background Intellectual Property and New Customer Intellectual Property or any other Customer property or information are identifiable.

  • Sativex® is a pump action oro-mucosal spray, which contains 2 whole plant extracts (Botanical Drug Substances, BDSs) of Cannabis sativa L.

  • ICH Q1A, Stability Testing of New Drug Substances and Products, International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, current revision.

  • Catalent shall perform testing, characterization and release of the Bulk Drug Substances and/or Drug Products.

  • Drug Substances) will be stored at no charge for up to [***] after Release of Conjugate Drug Substances; provided that any additional storage beyond [***] will be subject to availability and, if available, will be charged to Customer and will be subject to a separate agreement.

Related to Drug Substances

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Finished Products means any one or more of the following petroleum oils, or a mixture or combination of these oils, to be used without further processing except blending by mechanical means:

  • Finished Product means the final packaged product intended for human consumption;

  • Product means any deliverable under the Contract, which may include commodities, services, technology or software.