Process Transfer Materials definition

Process Transfer Materials is hereby restated in its entirety as follows: “‘Process Transfer Materials’ means the cell banks, reference standards and other materials to be provided by Amylin to Sandoz for the Process Characterization Phase, Analytical Activities, Post-Validation Characterization Activities, Pilot Studies, Process Validation Campaign and Commercial Phase, as listed in Schedule 4.” The following defined terms and definitions are hereby added to Clause 1(1): “‘Post-Validation Characterization Activities’ has the meaning set forth in Clause 3(2).” “‘Post-Validation Characterization Supply Fee’ has the meaning set forth in Schedule 4.” “‘Post-Validation Characterization Work Plan’ means an outline of the activities, timing and sampling to be performed under the Post-Validation Characterization Activities.”
Process Transfer Materials means the cell banks, reference standards and other materials to be provided by Amylin to Sandoz for the Process Characterization Phase, Analytical Activities, Post-Validation Characterization Activities, Pilot Studies, Process Validation Campaign and Commercial Phase, as listed in Schedule 4.” The following defined terms and definitions are hereby added to Clause 1(1): “‘Post-Validation Characterization Activities’ has the meaning set forth in Clause 3(2).” “‘Post-Validation Characterization Supply Fee’ has the meaning set forth in Schedule 4.” “‘Post-Validation Characterization Work Plan’ means an outline of the activities, timing and sampling to be performed under the Post-Validation Characterization Activities.”
Process Transfer Materials means the cell banks, reference standards and other materials to be provided by Amylin to Sandoz for the Process Characterization Phase, Analytical Activities, Process Intermediate Supply Activities, Pilot Studies, Process Validation Campaign and Commercial Phase, as listed in Schedule 4.

Examples of Process Transfer Materials in a sentence

  • SANDOZ shall store the Process Transfer Materials (see definition in CMA) at the proper labeled storage condition in qualified equipment.


More Definitions of Process Transfer Materials

Process Transfer Materials means the working cell bank vials, reference standards and antibody reagents to be provided by Unigene to Sandoz for the Analytical Phase, as listed in Schedule 4.
Process Transfer Materials means all relevant cell banks, reference standards and antibody reagents to be provided by Celltech to Biochemie for the Analytical Phase and Pilot Phase, as listed in Schedule 5.

Related to Process Transfer Materials

  • Supplier Materials has the meaning given in clause 8.1(h).

  • Customer Materials any materials, data, information, software, equipment or other resources owned by or licensed to You and made available to Us pursuant to facilitating Your use of the Services, including Customer Data.

  • Shareholder Materials means the Fund’s prospectus, statement of additional information and any other materials relating to the Fund provided to Fund shareholders by the Fund.

  • Cover material means soil placed over a soil dispersal component composed predominately of mineral material with no greater than ten percent organic content. Cover material may contain an organic surface layer for establishing a vegetative landscape to reduce soil erosion.

  • Contractor Materials means Materials owned or developed prior to the provision of the Work, or developed by Contractor independently from the provision of the Work and without use of the JBE Materials or Confidential Information.

  • Fertilizer material means a commercial fertilizer that either:

  • Third Party Materials means materials and information, in any form or medium, including any software, documents, data, content, specifications, products, equipment or components of or relating to the Services that are not proprietary to NCIT.

  • Service Provider Materials means all works of authorship, products and materials [including, but not limited to, data, diagrams, charts, reports, specifications, studies, inventions, software, software development tools, methodologies, ideas, methods, processes, concepts and techniques] owned by, or licensed to, the Service Provider prior to the Commencement Date or independently developed by the Service Provider outside the scope of this Agreement at no expense to Transnet, and used by the Service Provider in the performance of the Services;

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Electronic device technology means a technology involving

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

  • SAP Materials means any materials (including statistical reports) provided, developed or made available by SAP (independently or with Customer’s cooperation) in the course of performance under the Agreement, including in the delivery of any support or Professional Services to Customer. SAP Materials do not include the Customer Data, Customer Confidential Information or the Cloud Service. SAP Materials may also be referred to in the Agreement as “Cloud Materials”.

  • Charcoal lighter material means any combustible material designed to be applied on, incorporated in, added to, or used with charcoal to enhance ignition. “Charcoal Lighter Material” does not include any of the following: (A) electrical starters and probes, (B) metallic cylinders using paper tinder, (C) natural gas,

  • Biological Materials means certain tangible biological materials that are necessary for the effective exercise of the Patent Rights, which materials are described on Exhibit A, as well as tangible materials that are routinely produced through use of the original materials, including, for example, any progeny derived from a cell line, monoclonal antibodies produced by hybridoma cells, DNA or RNA replicated from isolated DNA or RNA, recombinant proteins produced through use of isolated DNA or RNA, and substances routinely purified from a source material included in the original materials (such as recombinant proteins isolated from a cell extract or supernatant by non-proprietary affinity purification methods). These Biological Materials shall be listed on Exhibit A, which will be periodically amended to include any additional Biological Materials that Medical School may furnish to Company.

  • Manufacturing Know-How means all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • Third Party Material means software, software development tools, methodologies, ideas, methods, processes, concepts and techniques owned by, or licensed to a third party and used by the Service Provider in the performance of the Services;

  • IP Materials has the meaning given to it in clause E8.1 (Intellectual Property Rights).

  • Manufacturing Materials means parts, tools, dies, jigs, fixtures, plans, drawings, and information produced or acquired, or rights acquired, specifically to fulfill obligations set forth herein.

  • Electronic Funds Transfer (EFT) indicator means a four-character suffix to the unique entity identifier. The suffix is assigned at the discretion of the commercial, nonprofit, or Government entity to establish additional System for Award Management records for identifying alternative EFT accounts (see subpart 32.11) for the same entity.

  • Construction materials means any tangible personal property that will be

  • Publicity Material means the promotional gifts, catalogues, pamphlets and all and any advertising and publicity material whatsoever which an Exhibitor wishes to display, distribute or use at the Exhibition.

  • Manufacturing Process means any process for—

  • Postconsumer material means a material or finished product that has served its intended use and has been discarded for disposal or recovery, having completed its life as a consumer item. Postconsumer material is a part of the broader category of “recovered material.”

  • Information Materials has the meaning given that term in Section 9.6.

  • Electronic nicotine delivery system or “(ENDS)” means any device that delivers a vaporized solution (including nicotine, THC, or any other substance) by means of cartridge or other chemical delivery systems. Such definition shall include, but may not be limited to, any electronic cigarette, vape pen, hookah pen, cigar, cigarillo, pipe, or personal vaporizer. ENDS are not FDA-approved nicotine replacement therapy devices.

  • Technical Information means technical data or computer software, as those terms are defined in the clause at DFARS 252.227-7013, Rights in Technical Data-Non Commercial Items, regardless of whether or not the clause is incorporated in this solicitation or contract. Examples of technical information include research and engineering data, engineering drawings, and associated lists, specifications, standards, process sheets, manuals, technical reports, technical orders, catalog-item identifications, data sets, studies and analyses and related information, and computer software executable code and source code.