BIOLOGICAL PROCESSES, 5000 LITER PROCESS PRODUCT
YIELD CANNOT BE
[*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
19
GUARANTEED AND MAY VARY. THE TARGET PER BATCH YIELD OF THE MODIFIED 5000 LITER
PROCESS FOR THE PRODUCT WILL BE ESTABLISHED BY AGREEMENT OF THE PARTIES (THE
"MODIFIED TARGET BATCH YIELD").
IF ANY BATCH OF PRODUCT (THE "ACTUAL BATCH
YIELD") IS LESS THAN NINETY PERCENT (90%) OF THE CURRENT TARGET BATCH YIELD OR
THE MODIFIED TARGET BATCH YIELD, AS THE CASE MAY BE, (EACH A "YIELD
DEFICIENCY"), IMCLONE AND LB AGREE TO ADJUST THE BATCH PRICE, ON A PRO-RATA
BASIS, TO REFLECT SUCH YIELD DEFICIENCY.
IF A YIELD DEFICIENCY EXISTS IMCLONE
SHALL BE ENTITLED TO A CASH PAYMENT (CREDITED AGAINST THE PRICE OF THAT BATCH)
IN AN AMOUNT EQUAL TO (A) THE BATCH PRICE MULTIPLIED BY *****. WITH REGARDS TO
PRODUCTS OTHER THAN ERBITUX®, THE PARTIES AGREE THAT THE TARGET BATCH YIELD AT
THE 5000 LITER PROCESS WILL BE AT LEAST 75% OF THE AVERAGE YIELD IMCLONE
GENERATED FROM ALL CGMP BATCHES AT ITS 1000 LITER FACILITY SCALED UP TO 5000
LITERS.
6.8.
SUPPLY FAILURE.
IF A SITUATION OF FORCE MAJEURE EXISTS SUCH THAT
LB IS UNABLE (OR THE PARTIES AGREE THAT THERE IS NO REASONABLE LIKELIHOOD THAT
LB WILL BE ABLE) TO DELIVER TO IMCLONE THE MINIMUM ORDER AND SUCH FURTHER
BINDING ORDERS AS MAY ARISE SUCH EVENT SHALL CONSTITUTE A "SUPPLY FAILURE."
6.8.1.
IN ADDITION TO IMCLONE'S REMEDY UNDER SECTION 6.10, SUPPLY FAILURE
SHALL ENTITLE IMCLONE TO EXERCISE THE RIGHT TO ELECT WITHIN A SIXTY (60) DAY
PERIOD TO TERMINATE THIS AGREEMENT PURSUANT TO ARTICLE 17.4.
6.8.2.
IN THE EVENT IMCLONE ELECTS NOT TO TERMINATE BUT RATHER TO TREAT
THE SUPPLY FAILURE AS A LATE DELIVERY, THE PROVISIONS OF SECTION 6.10 SHALL
APPLY
6.9.
COMPLIANCE WITH REGULATORY REQUIREMENTS.
LB SHALL COMPLY, AT LB'S
COST, WITH ALL REGULATORY REQUIREMENTS FROM TIME TO TIME APPLICABLE TO THE
SERVICES AND IN ACCORDANCE WITH THE OTHER APPLICABLE LEGAL AND REGULATORY
REQUIREMENTS OF THE FEDERAL, STATE AND LOCAL JURISDICTIONS
[*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.
CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
20
IN WHICH THE 5000 LITER MANUFACTURING SUITE IS LOCATED.
IF IMCLONE REQUESTS LB
TO COMPLY WITH ANY OTHER LEGAL OR REGULATORY REQUIREMENTS, LB SHALL USE
REASONABLE COMMERCIAL EFFORTS TO DO SO PROVIDED THAT:
6.9.1.
IMCLONE SHALL BE RESPONSIBLE FOR INFORMING LB IN WRITING OF THE
PRECISE REQUIREMENTS WHICH IMCLONE IS REQUESTING LB TO OBSERVE;
6.9.2.
SUCH REQUIREMENTS DO NOT CONFLICT WITH ANY MANDATORY REQUIREMENTS
UNDER THE LAWS OF THE LOCATION OF THE MANUFACTURE OF THE PRODUCT;
6.9.3.
LB SHALL BE UNDER NO OBLIGATION TO ENSURE THAT THE INFORMATION
FURNISHED BY IMCLONE PURSUANT TO SECTION 6.9.1 COMPLIES WITH THE APPLICABLE
REQUIREMENTS OF ANY JURISDICTION; AND
6.9.4.
ALL COSTS AND EXPENSES PROPERLY INCURRED BY LB