Common use of PRIOR EVENTS Clause in Contracts

PRIOR EVENTS. Each Party hereby acknowledges and agrees that a requirement by the FDA that the Company (i) reformat and reanalyze the clinical data from the two clinical studies (Nos.9923 and 0141) conducted by the Company in connection with the Registration Application submitted to the FDA on October 30, 2001 and (ii) submit data from clinical study No. 007 currently being conducted by Merck KGaA in Europe for the use of the Product to treat refractory colorectal cancer to support a resubmission of the Registration Application, does not constitute, in and of itself without further FDA requirements, a "material delay" under Section 4.8 of the Commercial Agreement or give rise, as of the date hereof, to "a significant concern regarding a regulatory or patient safety issue that would seriously impact the long term viability of all Products" under Section 13.3 of the Commercial Agreement; provided that this Section 7.1 does not, and shall in no circumstances be construed as, an admission of the occurrence of, or as an indication of what may constitute or be considered in the determination of the existence of, a "material delay" under Section 4.8 of the Commercial Agreement or such a "significant concern" under Section 13.3 of the Commercial Agreement. Confidential treatment requested by ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Company, ▇▇▇▇▇▇▇-▇▇▇▇▇ Squibb Biologics Company and ImClone Systems Incorporated.