Drug Substance. Dapoxetine HCl Batch 175MH1 6.57 kg (GMP batch used for CTM Product) • Dapoxetine HCl Batch 291MH0 1.567kg (GMP status not confirmed) • Dapoxetine HCl Batch 176MH1 1.6 kg (GMP status not confirmed)
Drug Substance. Stability study of batch 01- 402 Internal cost — FTE** [*] [*]€ Total [*]€ ** FTE rates at [*]€
Drug Substance. Additional test on batch 01- 402 (residual solvents, TFA and optical rotation) External cost* 07k€ Stability study of batch 01- 402 Internal cost — FTE** [*] 55k€ Retest of reference material Internal cost — FTE** [*] 11k€ Total 73k€ * Subcontracting of Additional test on batch 01- 402 at EXPANSIA + shipment ** FTE rates at [*]€
Drug Substance. The nalbuphine HCl drug substance is a [**]. Nalbuphine HCl is a [**]
Drug Substance. Each Clinical Batch of Drug Substance manufactured hereunder: (i) was manufactured and analyzed in conformance with the Master Production Record; (ii) was manufactured in compliance with the requirements of cGMP; (iii) was packaged in accordance with the Shipping Guidelines; (iv) was transferred free and clear of any liens or encumbrances of any kind to the extent arising through or as a result of the acts or omissions of LONZA; and (v) does not contain any substance that (1) causes such Clinical Batch to be adulterated within the meaning of the U.S. Federal Food, Drug and Cosmetic Act of 1938 and applicable regulations promulgated thereunder, as amended from time to time (“FDCA”) or comparable laws or regulations of another government agency or authority that has jurisdiction over the manufacture, testing, distribution, sale or use of Drug Substance or Product, or (2) is present in such Clinical Batch at a level that exceeds the level allowed under the FDCA or comparable laws or regulations of another government agency or authority that has jurisdiction over the manufacture, testing, distribution, sale or use of Drug Substance or Product;
Drug Substance. The aggregate quantities forecasted in a Binding Forecast for the months in any quarter may not be more than fifty percent (50%) above or fifty percent (50%) below the number of DS Batches for such quarter when it first appeared in the Semi-Binding Forecast, and the quantities forecasted for any month of the Binding Forecast may not be changed from the quantities forecasted for such month in the first Binding Forecast to include such month, without the prior written consent of Biogen on a case-by-case basis.
Drug Substance. The amounts forecasted by Bioverativ for each quarter within the Semi-Binding Forecast period may not be changed by Bioverativ to be more than fifty percent (50%) above or fifty percent (50%) below the number of DS Batches for such quarter when it first appeared in the Semi-Binding Forecast.
Drug Substance. Subject to the Quality Agreement, this Section 9.1 shall apply to Drug Substance manufactured and supplied by Biogen under this Agreement in the Second Phase and the Third Phase. For the avoidance of doubt, this Section 9.1 shall not apply to the First Phase.
Drug Substance. Tercica shall provide CBSB with all information in Tercica’s possession or control concerning any health hazards or potential health hazards associated with exposure to or the handling, storage, use or disposal of Drug Substance, including, without limitation, a Material Safety Data Sheet for Drug Substance. In the event that any such information is updated or corrected, Tercica shall promptly notify CBSB thereof and provide CBSB with the updated or corrected information.
Drug Substance. SPECIFICATIONS mean all the specifications and tests, analytical methods and/or limits, and the results thereof, as applicable, for DRUG SUBSTANCE agreed to by the Parties and listed in Exhibit 2 and to which DRUG SUBSTANCE has to conform.
