Production Process Development definition

Production Process Development means the development of processes and technology to facilitate production, purification, evaluation, characterization, stability assessment, vialing and distribution, and release of a Collaboration Antibody.
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Production Process Development means the development of processes and technology for the identification, isolation, selection, modification, production, purification, evaluation, characterization, stabilization, vialing and distribution, or release of an Antibody, Antibody Materials, or Antibody Product, including, without limitation, hybridoma fusion technology, phage display technology, isolation of variable region genes, modification of antibody variable and/or constant regions, development of antibody expression vectors, development of recombinant cells for antibody expression, development of antibody purification processes, and development of antibody stabilization processes or formulations.
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Examples of Production Process Development in a sentence

  • Out of the pool of Collaboration Antibodies against a given Collaboration Target, the Steering Committee will select the Collaboration Antibody that it believes to be most promising for development and commercialization and it will then move such Collaboration Antibody into Production Process Development.

  • Each Collaboration Antibody that is put into Production Process Development shall be deemed to be a "LEAD COLLABORATION ANTIBODY." It is understood that the Steering Committee may, over time, select more than one Lead Collaboration Antibody against a given Collaboration Target, or substitute one Lead Collaboration Antibody for another.

  • Upon designation of each Lead Collaboration Antibody, the Parties shall commence Production Process Development for such antibody.

  • With respect to each Lead Collaboration Antibody, the Steering Committee shall solicit bids from suppliers to perform the Production Process Development.

  • With respect to the Lead Collaboration Antibody, the Steering Committee shall solicit bids from suppliers to perform the Production Process Development.

  • Upon designation of each Lead Collaboration Antibody, each of Genmab/Medarex and deCODE shall commit to support fifty percent (50%) of the cost of Production Process Development for such Lead Collaboration Antibody, which cost is estimated to be two million dollars ($2,000,000) to three million dollars ($3,000,000) in the aggregate per Lead Collaboration Antibody, although such cost may vary depending on the particular characteristics of a given Lead Collaboration Antibody.

  • It is understood and agreed, however, that in no event shall any (y) Collaboration Antibody, Collaboration Product, or Production Process Development, or (z) Information and Inventions that would fall within the definition of "Excluded Claims" or "Excluded Know-How", be deemed to be subject to the assignment obligation set forth in this Section 12.1.4.

  • In the event the Steering Committee selects a Party to perform Production Process Development pursuant to this Section 1.2.8, and such Party agrees to do so, the price and other terms and conditions of such Production Process Development shall be based on arm's length negotiations with the Steering Committee.

  • Each Collaboration Antibody that is put into Production Process Development shall be deemed to be a "LEAD COLLABORATION ANTIBODY".

  • Provide one part time inspector, three (3) hour work days for 5 shifts.

Related to Production Process Development

  • 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, 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.

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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;

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