Process Development Program definition

Process Development Program means the development by Agilent of various processes for Customer including, without limitation, synthesis, cleavage, de-protection and purification conditions designed to increase scalability and yield of the manufacturing process of certain Molecules, as more specifically described in the Statement of Work.
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Process Development Program means the Bulk Process Development Program and the Product Development Program, collectively.
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Process Development Program means the program for the development of one or more processes, and associated technology, for the manufacture (including scale-up) of Research Antibodies and Candidate Drugs, including processes and technology for the production, purification, evaluation, characterization, stability assessment, vialing and release of a Research Antibody or a Candidate Drug, as applicable, and the performance of other related activities in support of the Registrations for a Candidate Drug or Licensed Product, which are to be conducted pursuant to the Process Science/Clinical Manufacture Agreement.
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Examples of Process Development Program in a sentence

  • Lilly and Ophidian will disclose and make available to each other promptly the results of the work conducted in the Clinical Development Program, Process Development Program and Manufacturing Program, including without limitation all preclinical, clinical, regulatory, and other information known by Lilly or Ophidian concerning the Drug Product at any time during the term of this Agreement.

  • The Project Team shall prepare and oversee the implementation of a detailed, overall process development plan, which shall address fully the key elements necessary for the Bulk Process Development Program and the Product Process Development Program and for the design and construction of necessary manufacturing facilities and shall further define the roles of each party in the Process Development Program (the "PROCESS DEVELOPMENT PLAN").

  • The Project Team shall provide the day-to-day management for the collaboration and shall be responsible for directing and overseeing specific activities hereunder, including but not limited to the Clinical Development Program, the Process Development Program and the Manufacturing Program.

  • Lilly will have principal responsibility for the Drug Product Process Development Program, manufacture of Drug Product from Bulk Drug Substance for clinical and commercial supply, the conduct of the Clinical Development Program, and filing and maintenance of regulatory documents necessary for Regulatory Approvals.

  • The Bulk Process Development Program and the Product Process Development Program shall commence as soon as practicable after the Effective Date.

  • As more fully described below, Ophidian will have principal responsibility for the Bulk Drug Substance Process Development Program, the Bulk Manufacturing Program and the manufacture (either itself or through a third party acceptable to Lilly) of Bulk Drug Substance for clinical and commercial supply.

  • Ants look for better execution plans where the paths correspond to the edges of the communication infrastructure of the Cloud.

  • It is also possible to have an exploratory discussion on the support possibilities available with the Secretary or a director.

  • Unit publication and entry into force of such legal texts different approach may be applied.

  • The Parties acknowledge and agree that, subject to the provisions of this Section 7.7, ABX shall have the right to make day-to-day operational decisions regarding the implementation of each Process Development Program and the conduct of its (or its subcontractors’) manufacturing activities, each within the scope of the applicable Process Development and Manufacturing Plan.

Related to Process Development Program

  • Commercial Development Plan means the written commercialization plan attached as Appendix E.

  • site development plan means a dimensioned plan drawn to scale that indicates details of the proposed land development, including the site layout, positioning of buildings and structures, property access, building designs and landscaping;

  • Initial Development Plan has the meaning set forth in Section 3.2(b).

  • Development Program means the implementation of the development plan.

  • Nuclear fuel cycle-related research and development activities means those activities which are specifically related to any process or system development aspect of any of the following: - conversion of nuclear material, - enrichment of nuclear material, - nuclear fuel fabrication, - reactors, - critical facilities, - reprocessing of nuclear fuel, - processing (not including repackaging or conditioning not involving the separation of elements, for storage or disposal) of intermediate or high-level waste containing plutonium, high enriched uranium or uranium-233, but do not include activities related to theoretical or basic scientific research or to research and development on industrial radioisotope applications, medical, hydrological and agricultural applications, health and environmental effects and improved maintenance.

  • Commercial Development means any development on private land that is not heavy industrial or residential. The category includes, but is not limited to: hospitals, laboratories and other medical facilities, educational institutions, recreational facilities, plant nurseries, multi-apartment buildings, car wash facilities, mini-malls and other business complexes, shopping malls, hotels, office buildings, public warehouses and other light industrial complexes.

  • Research and development means (1) theoretical analysis, exploration, or experimentation; or (2) the extension of investigative findings and theories of a scientific or technical nature into practical application for experimental and demonstration purposes, including the experimental production and testing of models, devices, equipment, materials, and processes. Research and development does not include the internal or external administration of radiation or radioactive material to human beings.

  • Research and development facility means an establishment engaged in laboratory, scientific, or experimental testing and development related to new products, new uses for existing products, or improving existing products. The term does not include an establishment engaged in efficiency surveys, management studies, consumer surveys, economic surveys, advertising, promotion, banking, or research in connection with literary, historical, or similar projects.

  • Global Development Plan has the meaning set forth in Section 3.1.

  • spatial development framework means the Kouga Municipal Spatial Development Framework prepared and adopted in terms of sections 20 and 21 of the Act and Chapter 2 of this By-Law;

  • Research Analyst means any individual employed by Loomis Sayles who has been designated as a Research Analyst or Research Associate by Loomis Sayles. A person is considered a Research Analyst only as to those Covered Securities which he or she is assigned to cover and about which he or she issues research reports to other Investment Persons or otherwise makes recommendations to Investment Persons beyond publishing their research. As to other securities, he or she is simply an Access Person.

  • Development Team means the entities and professionals assembled to develop and manage the Project, typically including the Applicant, Owner, Developer(s), Co-Developer(s) and general partner or any other related entities in which the Developer or Co-Developer has an identity of interest or a Controlling Interest.

  • Marketing program means a program established by order of the director pursuant to this act prescribing rules and regulations governing the marketing for processing, distributing, selling, or handling an agricultural commodity produced in this state or agricultural commodity input during a specified period and

  • Development Phase means the period before a vehicle type is type approved.

  • Development Plan has the meaning set forth in Section 3.2.

  • Infill development means new construction on a vacant commercial lot currently held as open space.

  • Project Management Plan means the management plan that (i) sets out a high level workplan to describe the manner in which the Design-Builder will manage the Project, including to address related matters such as traffic management and communications, and (ii) is prepared by or for the Design-Builder and submitted to the Owner;

  • Program Plan means the tobacco settlement program plan dated February 14, 2001, including exhibits to the program plan, submitted by the authority to the legislative council and the executive council, to provide the state with a secure and stable source of funding for the purposes designated by section 12E.3A and other provisions of this chapter.

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • Commercialization or “Commercialize” means activities directed to marketing, promoting, research and development as required, manufacturing for sale, offering for sale, distributing, importing or selling a product, including sub-licensing or sub-contracting of these activities.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Medical Affairs Activities means, with respect to any country or other jurisdiction in the Territory, the coordination of medical information requests and field based medical scientific liaisons with respect to Licensed Compounds or Licensed Products, including activities of medical scientific liaisons and the provision of medical information services with respect to a Licensed Compound or Licensed Product.

  • experimental development means acquiring, combining, shaping and using existing scientific, technological, business and other relevant knowledge and skills with the aim of developing new or improved products, processes or services. This may also include, for example, activities aiming at the conceptual definition, planning and documentation of new products, processes or services;

  • Commercialization Plan has the meaning set forth in Section 6.2.

  • Training program means an NCA-approved Iowa college, the Iowa law enforcement academy or an Iowa hospital approved by the department to conduct emergency medical care training.

  • Quality Assurance Program means the overall quality program and associated activities including the Department’s Quality Assurance, Design-Builder Quality Control, the Contract’s quality requirements for design and construction to assure compliance with Department Specifications and procedures.