Fermentation Scale-up Sample Clauses

Fermentation Scale-up. As part of the scale-up activities set forth in Section 2.2, Sicor shall Manufacture Ansamitocins in [***] Runs in accordance with Sub-section 2.3.3, to be used by Sicor in the Manufacture and supply of Product set forth in the following Sub-section. In the event that the Manufacture of DM1 and DM4 as set forth in Paragraph 2.3.2.1 does not result in at least [***] grams of such substances and of any other Maytansinoid Products consumed in performing analytical sampling and/or any other activities performed during such Runs agreed to in writing by ImmunoGen (the “Minimum Yield”), Sicor shall Manufacture Ansamitocins carrying out [***] Run. For purposes of determining the Minimum Yield, the quantity of said other Maytansinoid Products shall be considered on a proportional basis calculated from actual yields, as per the following example (said example not to be deemed indicative in any manner of the yields or sampling expected. If [***] gram of Ansamitocins (from Fermentations Scale-up) is used to Manufacture [***] gm DM1, and [***] grams of Ansamitocins are consumed for sampling, then for purpose of determining the Minimum Yield, it will be considered that [***] gram-equivalents of DM1 were used for sampling purposes. Furthermore, notwithstanding any of the foregoing, if prior to startup of the Chemical Synthesis Scale-up, laboratory scale production demonstrates a significantly lower yield (difference of [***]) of DM1 (from Ansamitocins) relative to that of DM4, then the overall quantities of DM4 required to reach the Minimum Yield (after subtracting DM1 and the aforementioned Maytansinoid Products) shall be adjusted proportionately. Portions of this Exhibit were omitted, as indicated by [***], and have been filed separately with the Secretary of the Commission pursuant to the Company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Sample 1
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