Process Development definition

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.

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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

• The Parties recognize that each of them has patent license arrangements with Third Parties and that it is the individual responsibility of each Party to secure any rights under the patents of Third Parties which may be needed to enable it to manufacture and/or market the product (including products manufactured using the process technology to be developed under the Process Development Projects) at such time as it determines in its sole judgement that such action is required.

• Third Amendment and Restatement of “S” Process Development Agreement between AMD and IBM *** *** ***Confidential Treatment Requested.

• Argonaut has established a Process Development Consortium ("PDC") to consist of up to ten (10) members which are from the pharmaceutical, biotechnology, and chemical industries, and Argonaut, for the purpose of discussing and identifying desirable features, concepts and designs for instrumentation for automating process development.

• In the case of mask work rights, such license includes the right to use any process-related mask design information provided to a Process Development Project (e.g. kerf test structures) and create derivative works thereof.

• Each Party shall have the right to audit the records of the other Party with respect to any Development Costs and Manufacturing Process Development Costs included in such reports, in accordance with Section 9.10.

More Definitions of Process Development

Process Development means, with respect to a product, all process development, process improvements, manufacturing scale-up, qualification and validation and quality assurance/quality control with respect to such product.

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 period commencing with a processing run using the Working Seed and ending on Validation;

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 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 as set forth in Section 3.1(b).

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. The method for manufacture, harvesting and purification of the Product comprising of Upstream Process and Downstream Process as described herein; “Upstream Process” shall mean the entire process from early cell isolation and cultivation, to cell banking and culture expansion of the cells until final harvest (termination of the culture and collection of the live cell batch); “Downstream Process” shall mean the bioprocess where the cell mass from the Upstream Process are processed to meet purity and quality requirements. Downstream Processing includes cell disruption, a purification section, a polishing section, analysis of final product, formulation and storage; [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED. “Certificate of Analysis” Certificate of analysis form issued by Kemwell and confirming that the Product belonging to each Batch to which the certificate relates, meets the applicable Specifications (including the results of analysis and testing of such Product), cGMP (in the case of cGMP Batches), Applicable Laws and such other criteria as identified on the certificate, in a form agreed to by the Client;