Process Development means all process development activities undertaken with respect to Products, including without limitation activities related to development and optimization of cell lines, expression systems, reagents, upstream process, downstream process, protein modification, development of the Manufacturing process, process scale-up, process characterization, and process validation for bulk drug substance and final dosage forms of the Products and their related placebos.
Process Development means all process development activities undertaken with respect to the Product, including activities related to [***]. [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Process Development means all process development activities undertaken with respect to the Product, including activities related to [***]. “Process Development Costs” means all costs invoiced by Third Parties to Coherus and/or its Affiliates for Process Development activities after the Effective Date directly resulting from any Process Development efforts as set forth in the Process Development Plan or otherwise approved by the JSC. Process Development Costs shall include [***], such as [***]. For the avoidance of doubt, the term ‘Process Development Costs’ shall include [***].
Examples of Process Development in a sentence
Partnering between DOE and the Contractor shall be conducted in a manner similar to the DOD Integrated Product and Process Development (IPPD) framework.
Efforts proposed by Offerors may cover all aspects of MCM Advanced Research and Development, including Non-Clinical Research and Development, Process Development, Platform Development, Formulation, Manufacturing, and Clinical Evaluation.
Research and development Research and development is subdivided into the areas of Formula Development, New Products & Applications and Process Development.
The audit disallowed QREs claimed for the 2011 "Fermentation - New Process Development" contract project on the ground that "no explanation was given outlining the contract research performed." (2) Audit Fermentation Projects and Application of the Shrink Back Rule.
Process Development Cost is amortised over a period of ten years.
More Definitions of Process Development
Process Development means the period commencing with a processing run using the Working Seed and ending on Validation;
Process Development shall be deemed to be initiated, with respect to a particular TA Library, at such time as synthetic feasibility studies used to define an efficient synthetic process for production of such TA Library have been commenced.
Process Development means the conduct by Paragon of activities to develop, confirm and/or refine processes for producing the Product and/or activities to develop and/or scale-up a Manufacturing Process suitable for cGMP manufacture of the Product.
Process Development means the exploration, identification, development and scale-up, pursuant to a Statement of Work, of (i) one or more new or improved Synthetic Pathways for manufacturing OLED Chemicals in quantities sufficient for supply on a commercial scale and on a cost-effective basis, including any processes intended to qualify as Validated Processes; (ii) new or improved Materials Specifications for such OLED Chemicals; and (iii) new or improved analytical methodologies, data and data analyses for characterizing such OLED Chemicals.
Process Development means with respect to a Product, all activities related to process development of API or Product, including the(a) raw materials selection, (b) manufacturing development, (c) test method development of raw materials, (d) in-process products, (e) intermediate products, API and Product, (f) formulation development, (g) stability studies of raw material, buffers, intermediates products, API and Product, (h) viral safety steps development and validation, (i) process robustness and process validation, (j) analytical method validation for quality controls of raw materials, intermediates, API and Product, (k) shipment validation, (l) container closure study, (m) leachable and extractable study, (n) cleaning development and validation, (o) column lifetime study, (p) filing support for regulatory submissions.
Process Development means costs of producing Products for sale which are incurred prior to attainment of full-scale commercial production capacity and yields of Products in any facility and are in excess of the standard costs of producing Products reasonably expected to be included in that facility upon attainment of full-scale commercial production capacity and yields.
Process Development means, when undertaken by Juvaris on behalf of a Juvaris Customer, as applicable, using, making, having made or importing the methods, compositions of matter or articles of manufacture embodied by the Patent Rights or the Know-How, but only as it directly relates to those activities customarily associated with or reasonably necessary for the development of manufacturing or scale-up processes reasonably required for the commercial or clinical production of a plasmid DNA product, including for example preclinical studies, GLP toxicology studies and other activities to support an IND filing, and clinical trials; provided, however, that, notwithstanding anything to the contrary, production of material for use in a clinical study, such as, for example, a Phase IIb clinical trial, that was not intended to be a pivotal trial but is determined later to be suitable to qualify as a pivotal trial will be deemed to be Process Development.