Expression Optimization Sample Clauses

Expression Optimization. (a) In the event that SFI determines that a supplied Humanized [ ] Antibody meets the Desired Binding Affinity, or is sufficiently close thereto for SFI to wish to proceed with that antibody further, it shall so inform PDL. PDL will then optimize the expression process and producer cell line having the Desired Process and Cell Line Characteristics as defined below to achieve a production yield of at least [ ] mg/106 cells/24 hours measured under standard tissue culture conditions. It will then transfer to SFI the production process and the producer cell line. The production process shall be scaleable and adaptable to pilot production and the cell line shall be sterile (but free of chemical sterilizers), and mycoplasma-free (hereinafter "Desired Process and Cell Line Characteristics"). It is anticipated that the Program will be completed to this point in approximately 6 months. (b) PDL will use its best efforts over a period of approximately three months to perform further amplification(s) to increase the production yield to at least [ ] mg/106 cells/24 hours measured under standard tissue culture conditions, and will provide to SFI the modified production process and producer cell line having the Desired Process and Cell Line Characteristics and being adaptable to growing serum free. After delivering this cell line, PDL will use its best efforts to develop a clone of such producer cell line which, according to appropriate tests and analysis performed by PDL, allows stable production at such yields for at least two months. PDL shall provide to SFI such producer cell line. SANDOZ acknowledges that while PDL will exert best efforts in this Phase D(b), SANDOZ recognizes that there is no guarantee that PDL will achieve the yields and other requirements specified herein. (c) In the event that SFI informs PDL that it wishes to proceed with further evaluation with a view to possible development of a [ ] Antibody delivered by PDL under Phase A of the Program, PDL will perform the steps set forth in sub-paragraphs (a) and (b) above to optimize the expression process and producer cell line for that [ ] Antibody, and shall transfer to SFI the expression processes and producer cell lines, which shall have the Desired Process and Cell Line Characteristics.
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