For the sake of clarity, an example illustrating how the above forecast variances function is attached hereto as Exhibit C.
Notwithstanding the foregoing limitations, both Parties acknowledge that market conditions, unexpected demand, new science and technology, the economy, and other factors beyond either Party's control, could lead to variances in Commercial Requirements and/or Clinical Requirements beyond those set forth above. In such event, the Parties will discuss such unexpected variances and OSI shall use Commercially Reasonable Efforts to accommodate them.
5.3 Delivery of Purchase Orders. Beginning no earlier than the filing of the final clinical section of the NDA with the FDA, Genentech shall deliver binding purchase orders for each calendar month to OSI at least three (3) months prior to the requested delivery date, separately requesting Commercial Requirements, Clinical Requirements for Finished Product and Clinical Requirements for Placebo, all in accordance with the amounts provided in the then current Rolling Monthly Forecast. With respect to Clinical Supplies, Genentech shall also provide fully approved labeling requirements for such Clinical Supplies. Each purchase order shall also specify delivery dates and delivery location (CPT (Incoterms 2000) to either Genentech's South San Francisco manufacturing facility or another destination
specified by Genentech, but limited to one location per purchase order). Genentech agrees that orders for Commercial Requirements shall be by full case of Finished Product; Clinical Requirements for Finished Product and/or Placebo may be by partial case. The Parties agree that title to the Finished Product shall pass from OSI to Genentech upon the delivery of such Finished Product from OSI to Genentech or Genentech's designated destination. As of the Effective Date, a full case consists of **, although such composition may be changed upon mutual agreement between the Parties.
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