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.

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

• Upon request, Contractor shall provide CO and COR with the following contract funded documents as specified below but not limited to: Process Development Reports; Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, Contractor/Subcontractor Standard Operating Procedures (SOP’s), Master Production Records, Certificate of Analysis, Clinical Studies Data or Reports.

• 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.

• 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.

• Charges for Process Development Wafers shall be determined pursuant to Section 3 of Exhibit A.

• A request to substantively change the MRO Regional Reliability Standards Process Development process shall begin with the preparation of a SAR, and be handled using the same procedure as a request to revise a MRO Regional Reliability Standard.

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 the conduct by SK of activities to develop, confirm and/or refine processes for producing the Antigen Product or Vaccine Product and/or activities to develop, scale-up, optimize, qualify and/or validate the Manufacturing Process (including process performance qualification) suitable for GMP Manufacture of the Antigen Product or Vaccine Product, as the case may be.

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 means the development, qualification, validation and scale-up of the process to manufacture the Product, and any analytic development and Product characterization with respect thereto, beginning with final clone selection and upstream process development and terminating upon the completion of the process scale up activities prior to tech transfer to a CMO, in each case, as described in the CMC Plan, as such CMC Plan exists on upon the Effective Date.