LB SHALL MAKE COMMERCIALLY REASONABLE EFFORTS TO MANUFACTURE THE
MINIMUM ORDER WITHIN APPROXIMATELY FIVE (5) YEARS FROM THE EFFECTIVE DATE OF THE
AGREEMENT. A CAMPAIGN SHALL CONSIST OF A MINIMUM SERIES OF THREE (3) BATCHES OF
A SINGLE PRODUCT. A MINIMUM OF ***** IN THE FIRST YEAR OF THE AGREEMENT AND A
MINIMUM OF ***** TO COMMENCE IN EACH SUBSEQUENT YEAR. THE NUMBER OF CAMPAIGNS
AND THE NUMBER OF BATCHES IN EACH CAMPAIGN SHALL BE AGREED BETWEEN PARTIES PRIOR
TO THE COMMENCEMENT OF THAT CALENDAR YEAR.
4.2.
LB SUPPLY OBLIGATIONS.
FOR EACH BATCH OF PRODUCT ORDERED BY
IMCLONE HEREUNDER, LB WILL PERFORM ALL SERVICES NECESSARY TO MANUFACTURE AND
DELIVER THE PRODUCT IN ACCORDANCE WITH CGMP, INCLUDING:
4.2.1.
RECOVER AMPOULES OF THE CELL BANK FOR THE CELL LINE AND EXPAND
CULTURES TO COMPLETE AIRLIFT FERMENTATION AT 5000 LITER SCALE IN THE 5000 LITER
MANUFACTURING SUITE.
EACH BATCH SHALL BE PRODUCED AS ONE LOT FROM ONE AMPOULE
OF THE CELL BANK PROVIDED BY IMCLONE.
4.2.2.
CLARIFY CULTURE SUPERNATANT AND PURIFY USING THE 5000-LITER PROCESS
4.2.3.
TEST THE PRODUCT AGAINST THE SPECIFICATIONS.
ADDITIONAL PRODUCT
AND IN PROCESS SAMPLES MAY BE TAKEN AT IMCLONE'S REQUEST FOR FURTHER ANALYSIS.
ALTERNATIVELY, ADDITIONAL TESTS MAY BE PERFORMED BY LB AT A PRICE AND UNDER
TERMS AND CONDITIONS TO BE AGREED.
4.2.4.
REVIEW REQUIREMENTS (IF ANY) FOR 5000 LITER PROCESS MODIFICATIONS
IN ORDER TO MEET THE SPECIFICATIONS FOR MANUFACTURE OF SUBSEQUENT BATCHES
[*****] 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.
16
AND NOTIFY IMCLONE OF SUCH PROPOSED MODIFICATIONS.
ANY SUCH 5000 LITER PROCESS
MODIFICATIONS ARE SUBJECT TO SECTION 9.1.
4.2.5.
UNDERTAKE CGMP REVIEW OF LOT DOCUMENTATION, DEFINE PRODUCT
DISPOSITION, AND ISSUE A CERTIFICATE OF ANALYSIS.
4.2.6.
DELIVER THE PRODUCT TO IMCLONE.
4.2.7.
UPON THE FDA'S REQUEST, AND AT LB'S EXPENSE, CONDUCT AN FDA
INSPECTION OF 5000 LITER MANUFACTURING SUITE SEEKING APPROVAL TO MANUFACTURE THE
PRODUCT AT LB'S FACILITY.
4.2.8.
UPON IMCLONE'S REQUEST, LB SHALL PERMIT AN IMCLONE EMPLOYEE OR
REPRESENTATIVE TO BE PRESENT AT LB'S FACILITIES DURING THE PRODUCTION OF ANY
PRODUCT BY LB FOR IMCLONE OR ANY INSPECTION RELATING TO SUCH PRODUCT.
5.
ORDER QUANTITIES AND ORDER PROCEDURES.
5.1 MINIMUM ORDERS
THE MINIMUM ORDER OF ***** BATCHES SHALL BE SCHEDULED BY LB ACCORDING TO THE
FREELY AVAILABLE CAPACITY IN THE 5000L SUITE AS MUTUALLY AGREED BY IMCLONE. THE
FIRST CAMPAIGN SHALL BE SCHEDULED TO COMMENCE WITHIN 4 MONTHS OF INITIATION OF
THE TECH TRANSFER OF THE FIRST PRODUCT. INITIATION OF THE TECH TRANSFER FOR THE
FIRST PRODUCT IS EXPECTED TO COMMENCE WITHIN 4 MONTHS OF THE EFFECTIVE DATE OF
THIS AGREEMENT.
5.2 ADDITIONAL ORDERS.
ANY ORDERS REQUIRED BY IMCLONE IN ADDITION TO THE MINIMUM ORDER, SHALL BE
REQUESTED IN WRITING TO LB ON A (12) MONTH ROLLING BASIS, FROM THE EFFECTIVE
DATE OF THE AGREEMENT. ANY SUCH
[*****] REPRESENTS CONFIDENTIAL PORTION WHICH HAS BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.