Exhibit 10.30

 

5000 LITER SCALE MULTI- PRODUCT SUPPLY AGREEMENT

 

between

 

LONZA BIOLOGICS PLC

 

and

 

IMCLONE SYSTEMS INCORPORATED

 

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TABLE OF CONTENTS

 

 

ARTICLE

 

TITLE

 

 

 

 

 

 

 

1

 

Definitions

 

 

 

 

 

 

 

2

 

Term

 

 

 

 

 

 

 

3

 

Supply by ImClone

 

 

 

 

 

 

 

4

 

Agreement to Supply

 

 

 

 

 

 

 

5

 

Order Quantities and Ordering Procedures

 

 

 

 

 

 

 

6

 

Provision of the Services

 

 

 

 

 

 

 

7

 

Delivery and Transportation of Products; ImClone Tests

 

 

 

 

 

 

 

8

 

Steering Committee

 

 

 

 

 

 

 

9 [a05-8843_1ex10d30.htm#a9_ProcessChanges__171307]

 

Process Changes [a05-8843_1ex10d30.htm#a9_ProcessChanges__171307]

 

 

 

 

 

 

 

10 [a05-8843_1ex10d30.htm#a10_SharedManufacturing__171314]

 

Shared Manufacturing [a05-8843_1ex10d30.htm#a10_SharedManufacturing__171314]

 

 

 

 

 

 

 

11 [a05-8843_1ex10d30.htm#a11_RegulatorySupportAndQualityAs_171316]

 

Regulatory Support and Quality Assurance
[a05-8843_1ex10d30.htm#a11_RegulatorySupportAndQualityAs_171316]

 

 

 

 

 

 

 

12 [a05-8843_1ex10d30.htm#a12_ThisSectionLeftIntentionallyB_103302]

 

Excess Capacity [a05-8843_1ex10d30.htm#a12_ThisSectionLeftIntentionallyB_103302]

 

 

 

 

 

 

 

13 [a05-8843_1ex10d30.htm#a13_PriceAndTermsOfPayment__171341]

 

Price and Terms of Payment
[a05-8843_1ex10d30.htm#a13_PriceAndTermsOfPayment__171341]

 

 

 

 

 

 

 

14 [a05-8843_1ex10d30.htm#a14_WarrantiesCovenantsLimitation_171350]

 

Warranties, Limitation of Liabilities, etc.
[a05-8843_1ex10d30.htm#a14_WarrantiesCovenantsLimitation_171350]

 

 

 

 

 

 

 

15 [a05-8843_1ex10d30.htm#a15_LimitationsOfLiability__175650]

 

Limitations of Liability
[a05-8843_1ex10d30.htm#a15_LimitationsOfLiability__175650]

 

 

 

 

 

 

 

16 [a05-8843_1ex10d30.htm#a16_ImcloneInformationLbInformati_175656]

 

ImClone Information, LB Information and Patent Rights
[a05-8843_1ex10d30.htm#a16_ImcloneInformationLbInformati_175656]

 

 

 

 

 

 

 

17 [a05-8843_1ex10d30.htm#a17_Termination__175707]

 

Termination [a05-8843_1ex10d30.htm#a17_Termination__175707]

 

 

 

 

 

 

 

18 [a05-8843_1ex10d30.htm#a18_ForceMajeure__175712]

 

Force Majeure [a05-8843_1ex10d30.htm#a18_ForceMajeure__175712]

 

 

 

 

 

 

 

19 [a05-8843_1ex10d30.htm#a19_GoverningLawJurisdictionAndEn_175717]

 

Governing Law, Jurisdiction and Enforceability
[a05-8843_1ex10d30.htm#a19_GoverningLawJurisdictionAndEn_175717]

 

 

 

 

 

 

 

20 [a05-8843_1ex10d30.htm#a20_Miscellaneous__175726]

 

Miscellaneous [a05-8843_1ex10d30.htm#a20_Miscellaneous__175726]

 

 

 

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[*****] 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.

 

2

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ATTACHMENTS

 

Attachment 1 — Final Product Specifications
[a05-8843_1ex10d30.htm#Attachment1_174337]

 

 

Attachment 2 — Tech Transfer [a05-8843_1ex10d30.htm#Attachment2_174343]

 

 

 

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[*****] 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.

 

3

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This Multi- Product SUPPLY AGREEMENT, dated as of March 17, 2005, is by and
between LONZA BIOLOGICS PLC, an English corporation (“LB”), of 228 Bath Road,
Slough, Berkshire SL1 4DX, England, and IMCLONE SYSTEMS INCORPORATED, a Delaware
corporation (“ImClone”), of 180 Varick Street, New York, NY 10014.

 

W I T N E S S E T H:

 

WHEREAS, LB has available manufacturing capacity in the 5000 liter scale; and

 

WHEREAS, ImClone has desire to utilize said existing capacity;

 

NOW, THEREFORE, the parties hereto agree as follows:

 

1.             DEFINITIONS.

 

1.1.          IN THIS AGREEMENT, THE FOLLOWING TERMS HAVE THE MEANINGS SET FORTH
BELOW:

 

1.1.1.       “AFFILIATE” MEANS ANY CORPORATION, PARTNERSHIP, LIMITED LIABILITY
COMPANY OR OTHER ENTITY, WHICH DIRECTLY OR INDIRECTLY CONTROLS, IS CONTROLLED BY
OR IS UNDER COMMON CONTROL WITH THE RELEVANT PARTY TO THIS AGREEMENT, AND
“CONTROL” AND ITS CORRELATES MEANS THE OWNERSHIP OF MORE THAN FIFTY PERCENT
(50%) OF THE ISSUED VOTING SHARES, OR THE LEGAL POWER TO DIRECT OR CAUSE THE
DIRECTION OF THE GENERAL MANAGEMENT AND POLICIES, OF THE PARTY IN QUESTION.

 

1.1.2.       “AGREEMENT” MEANS THIS PRODUCT SUPPLY AGREEMENT BETWEEN LB AND
IMCLONE.

 

1.1.3.       “BATCH” MEANS THE QUANTITY OF TOTAL BULK PURIFIED PRODUCT
(INCLUDING SAMPLES TAKEN DURING THE 5000 LITER PROCESS) WHICH IS PRODUCED AS A
RESULT OF THE COMPLETION OF ONE OPERATION OF THE 5000 LITER PROCESS FOR THE

 

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[*****] 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.

 

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PRODUCT IN THE 5000 LITER MANUFACTURING SUITE IN ACCORDANCE WITH THE
SPECIFICATIONS AND WITH CGMP.

 

1.1.4.       “BATCH PRICE” MEANS THE SUM WHICH IS PAYABLE TO LB FOR THE
PERFORMANCE OF THE SERVICES WITH RESPECT TO A BATCH AS DETERMINED PURSUANT TO
ARTICLE 13 HERETO, WHICH FEE COMPENSATES LB FOR, AMONG OTHER THINGS:

 

(I)            STORAGE OF THE CELL BANKS OF THE CELL LINE DURING THE TERM OF
THIS AGREEMENT;

 

(II)           PREPARATION AND MAINTENANCE OF MANUFACTURING DOCUMENTS FOR THE
MANUFACTURE OF BULK PRODUCT;

 

(III)          PERFORMANCE OF THE CELL CULTURE PHASE OF THE 5000 LITER PROCESS;

 

(IV)          PERFORMANCE OF THE PURIFICATION PHASE OF THE 5000 LITER PROCESS;

 

(V)           ANALYSIS OF PRODUCT ACCORDING TO THE SPECIFICATIONS;

 

(VI)          REVIEW OF COMPLETED BATCH RECORDS; AND

 

(VII)         THE COSTS OF OPERATING THE 5000 LITER MANUFACTURING SUITE
(INCLUDING BUT NOT LIMITED TO THE USE AND OPERATION OF ALL EQUIPMENT AND SUPPLY
OF UTILITIES);

 

(viii)        the costs of all raw materials excluding purification resins, are
included in the Batch Price set forth in Section 13.1.1.Purifcation resins shall
be charged at cost to ImClone.

 

1.1.5.       THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.6.       “CELL LINE” MEANS THE CELL LINE USED IN THE MANUFACTURE OF THE
PRODUCT THEN BEING PRODUCED, AS THE SAME MAY BE AMENDED FROM TIME TO TIME IN
ACCORDANCE WITH THE PROVISIONS OF THIS AGREEMENT.

 

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[*****] 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.

 

5

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1.1.7.       “CERTIFICATE OF ANALYSIS” MEANS A DOCUMENT CERTIFYING THAT LB HAS
PERFORMED CERTAIN TESTS SPECIFIED AND AGREED TO BY BOTH PARTIES ON EACH BATCH OF
PRODUCT AND CONTAINING THE RESULTS OF THOSE TESTS AND WHETHER OR NOT THE BATCH
OF SUCH PRODUCT MEETS AGREED UPON SPECIFICATIONS; AND CERTIFYING THAT THE BATCH
OF SUCH PRODUCT WAS MANUFACTURED IN ACCORDANCE WITH THE APPROVED PROCESS.

 

1.1.8.       “CGMP” MEANS CURRENT GOOD MANUFACTURING PRACTICES AS PROMULGATED
UNDER AND IN ACCORDANCE WITH ICH Q7A GMP GUIDELINES AND THE U.S. FEDERAL FOOD,
DRUG AND COSMETIC ACT, 21CFR (PARTS 210, 211, 600 AND 610) AND THE GUIDE TO GOOD
MANUFACTURING PRACTICES FOR MEDICINAL PRODUCTS AS PROMULGATED UNDER EUROPEAN
DIRECTIVE 91/356/EEC, AS APPROPRIATE.

 

1.1.9.       THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.10.     “DELIVER” OR “DELIVERY” HAS THE MEANING ASCRIBED TO IT IN
SECTION 7.1.

 

1.1.11.     “DELIVERY DATE” MEANS, WITH RESPECT TO A PARTICULAR BATCH, THE DATE
OF ISSUANCE OF A CERTIFICATE OF ANALYSIS BY LB OR THE DATE ON WHICH A GIVEN
BATCH OF PRODUCT, CONFORMING TO THE SPECIFICATIONS, IS MADE AVAILABLE FOR
DELIVERY TO IMCLONE, EXW (EX-WORKS) LB (NH)’S PREMISES, WHICHEVER IS LATER.

 

1.1.12.     “EFFECTIVE DATE” MEANS THE DATE OF THIS AGREEMENT SET FORTH IN PAGE
1.

 

1.1.13.     “FERMENTER TRAIN” MEANS TWO SEED REACTORS (50L AND 500L) AND THE
PRODUCTION REACTOR (5000L).

 

1.1.14.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

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[*****] 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.

 

6

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1.1.15.     “IMCLONE INFORMATION” MEANS ALL KNOW-HOW, TECHNICAL INFORMATION AND
OTHER INFORMATION KNOWN TO, CONTROLLED BY OR OWNED BY IMCLONE OR ITS AFFILIATES
FROM TIME TO TIME AND NOT KNOWN TO AND AT THE FREE DISPOSAL OF LB PRIOR TO ITS
DISCLOSURE BY IMCLONE TO LB OR LB (NH) OR THEIR RESPECTIVE AFFILIATES AND NOT
FREELY AVAILABLE IN THE PUBLIC DOMAIN INCLUDING, WITHOUT LIMITATION, THE CELL
LINE, THE 5000 LITER PROCESS, AND THE PRODUCT.

 

1.1.16.     “IMCLONE MATERIALS” MEANS THE MATERIALS SUPPLIED OR TO BE SUPPLIED
BY IMCLONE TO LB OR LB (NH) OR THEIR RESPECTIVE AFFILIATES PURSUANT TO ARTICLE 3
OR SUPPLIED PURSUANT TO PREVIOUS SERVICES AGREEMENTS BETWEEN THE PARTIES. 
IMCLONE MATERIALS SHALL INCLUDE THE CELL LINE AND PURIFICATION RESINS.  IMCLONE
SHALL HAVE AND SHALL RETAIN ALL RIGHTS TO IMCLONE MATERIALS EXCEPT AS
SPECIFICALLY PROVIDED IN SECTION 3.3.

 

1.1.17.     “IMCLONE PATENT RIGHTS” MEANS ALL PATENT RIGHTS THAT ARE OWNED BY OR
LICENSED TO IMCLONE FROM TIME TO TIME DURING THE TERM HEREOF.

 

1.1.18.     “IMCLONE TESTS” MEANS THE TESTS THAT BOTH PARTIES HAVE AGREED WILL
BE CARRIED OUT ON THE PRODUCT FOLLOWING ITS RECEIPT BY IMCLONE, AS MODIFIED FROM
TIME TO TIME BY WRITTEN AGREEMENT BETWEEN THE PARTIES.

 

1.1.19.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.20.     “5000 LITER MANUFACTURING SUITE” MEANS THE 5000 LITER CGMP
MANUFACTURING FACILITY LOCATED AT THE LB (NH) PORTSMOUTH, NEW HAMPSHIRE
MANUFACTURING SITE, WHICH SHALL INCLUDE TWO 5000 LITER (5000L) AIRLIFT FERMENTER
AND ASSOCIATED SEED TRAINS, HARVEST AND PURIFICATION EQUIPMENT.

 

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[*****] 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.

 

7

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1.1.21.     “5000 LITER PROCESS” MEANS THE PROCESS FOR THE PRODUCTION OF THE
PRODUCT FROM THE CELL LINE, AS SUCH PROCESS IS TRANSFERRED FROM IMCLONE TO LB
UNDER AN APPROPRIATE TECHNOLOGY TRANSFER AGREEMENT BETWEEN THE PARTIES.

 

1.1.22.     “PRODUCT” MEANS ANY PRODUCT MADE FROM A CELL LINE AND PROCESS WHICH
ARE COMPATIBLE WITH MANUFACTURE IN THE 5000 LITER MANUFACTURING SUITE INCLUDING
THE MONOCLONAL ANTIBODY KNOWN AS ERBITUXÂ (CETUXIMAB AND FORMERLY KNOWN AS
IMC-C225) (INCLUDING ANY SAMPLE THEREOF).  IMCLONE SHALL NOTIFY LB OF ANY CHANGE
IN THE IDENTITY OR FORMULATION OF THE THEN-CURRENT PRODUCT NO LATER THAN SIX (6)
MONTHS BEFORE THE COMMENCEMENT OF MANUFACTURE. NOTWITHSTANDING THE FOREGOING,
THE PARTIES UNDERSTAND THAT ANY PRODUCT TO BE MANUFACTURED IN THE 5000 LITER
MANUFACTURING SUITE MUST HAVE A PROCESS SIMILAR TO THE PRODUCTION PROCESS FOR
ERBITUXÂ, (I.E. SIMILAR FERMENTATION TIME IN THE PRODUCTION REACTOR AND A
SIMILAR PURIFICATION TIME.).  IF THE PRODUCTION PROCESS REQUIRES MORE
FERMENTATION TIME OR ADDITIONAL PURIFICATION TIME THE BATCH PRICE FOR THE
PRODUCT WILL BE ADJUSTED ACCORDINGLY. IMCLONE SHALL NOTIFY LB OF THE PRODUCT AND
ANY SUBSTITUTE PRODUCT NO LATER THAN SIX (6) MONTHS BEFORE THE COMMENCEMENT OF
MANUFACTURE. BEFORE COMMENCEMENT OF THE CAMPAIGNS PARTICULARS OF THE PRODUCT
WILL BE SET OUT IN ATTACHMENTS TO THIS AGREEMENT AS AMENDED FROM TIME TO TIME IN
ACCORDANCE WITH THIS AGREEMENT OR ANY NEW FORMULATION OF SUCH ANTIBODY.

 

1.1.23.     “LB (NH)” MEANS LB’S AFFILIATE, LONZA BIOLOGICS, INC. OF PORTSMOUTH,
NEW HAMPSHIRE.

 

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[*****] 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.

 

8

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1.1.24.     “LB INFORMATION” MEANS ALL KNOW-HOW, TECHNICAL INFORMATION AND OTHER
INFORMATION KNOWN TO, OWNED BY OR CONTROLLED BY LB OR ITS AFFILIATES FROM TIME
TO TIME, AND NOT KNOWN TO AND AT THE FREE DISPOSAL OF IMCLONE PRIOR TO ITS
DISCLOSURE BY LB TO IMCLONE AND NOT FREELY AVAILABLE IN THE PUBLIC DOMAIN.

 

1.1.25.     “LB PATENT RIGHTS” MEANS ALL PATENT RIGHTS OF WHICH LB OR ANY OF ITS
AFFILIATES IS FROM TIME TO TIME THE OWNER DURING THE TERM HEREOF.

 

1.1.26.     “OUT OF FREEZE” SHALL MEAN THE DATE THAT THE VIAL OF PRODUCT CELLS
IS THAWED TO START MANUFACTURE OF A BATCH.

 

1.1.27.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.28.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.29.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.30.     “MINIMUM ORDER” SHALL MEAN ***** BATCHES OF THE PRODUCT OR, IF A
SUBSTITUTE PRODUCT IS USED, SUCH BATCH QUANTITY AS REASONABLY DETERMINED BY THE
STEERING COMMITTEE.

 

1.1.31.     “PATENT RIGHTS” MEANS ALL PATENTS AND PATENT APPLICATIONS OWNED OR
LICENSED OF ANY KIND THROUGHOUT THE WORLD, INCLUDING WITHOUT LIMITATION ALL
SUBSTITUTIONS, EXTENSIONS, REISSUES, RENEWALS, AND INVENTOR CERTIFICATES, AND
PATENTS ISSUING FROM APPLICATIONS (INCLUDING PROVISIONALS, DIVISIONALS,
CONTINUATIONS AND CONTINUATIONS IN PART).

 

1.1.32.     “PRESIDENTS” HAS THE MEANING ASCRIBED TO IT IN SECTION 8.3.

 

1.1.33.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

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[*****] 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.

 

9

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1.1.34.     “PRODUCER PRICE INDEX” OR “PPI” MEANS THE PRODUCER PRICE INDEX FOR
PHARMACEUTICAL PRESCRIPTION PREPARATIONS, PRESCRIPTION (“PPI” SERIES ID PCU
325412325412, AS REPORTED BY THE BUREAU OF LABOR STATISTICS OF THE U.S.
DEPARTMENT OF LABOR OR, IF SUCH INDEX IS NO LONGER AVAILABLE, SUCH INDEX BY
WHICH IT IS REPLACED BY THE BUREAU OF LABOR STATISTICS OR ANY SUCCESSOR U.S.
AGENCY ISSUING SUCH INDICES.  IF SUCH INDEX IS DISCONTINUED AND THERE IS NO
DIRECT SUCCESSOR INDEX, THE STEERING COMMITTEE SHALL DESIGNATE AN APPROPRIATE
INDEX THAT APPROXIMATES AS CLOSELY AS POSSIBLE SUCH BUREAU OF LABOR STATISTICS
INDEX.

 

1.1.35.     “RAW MATERIALS” MEANS ALL MATERIALS, AND SUPPLIES, WHICH ARE
PURCHASED OR USED BY LB IN THE PERFORMANCE OF THE SERVICES.

 

1.1.36.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.37.     “SERVICES” MEANS THE SERVICES TO BE PROVIDED BY LB WHICH ARE THE
SUBJECT OF THIS AGREEMENT, INCLUDING WITHOUT LIMITATION, THE SERVICES DESCRIBED
IN ARTICLE 4 BELOW AND THE PROVISION OF PERSONNEL AND OPERATION OF RELEVANT
PLANT AND EQUIPMENT TO ACCOMPLISH THOSE SERVICES.

 

1.1.38.     THIS SECTION LEFT INTENTIONALLY BLANK.

 

1.1.39.     “SPECIFICATIONS” MEANS THE SPECIFICATIONS FOR EACH PRODUCT, AS
ESTABLISHED BEFORE COMMENCEMENT OF ANY CAMPAIGN BY IMCLONE AND CONFIRMED THROUGH
DESIGNATED BATCHES AS MUTUALLY AGREED BETWEEN PARTIES WHICH SPECIFICATIONS MAY
BE MODIFIED FROM TIME TO TIME PURSUANT TO SECTION 9.

 

1.1.40.     “STEERING COMMITTEE” MEANS THE COMMITTEE ESTABLISHED PURSUANT TO
SECTION 8.1.

 

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[*****] 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.

 

10

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1.1.41.     “TESTING LABORATORIES” MEANS ANY THIRD PARTY INSTRUCTED BY LB TO
CARRY OUT TESTS ON THE IMCLONE MATERIALS OR THE PRODUCT.

 

1.2.          UNLESS THE CONTEXT REQUIRES OTHERWISE, REFERENCES TO THE SINGULAR
INCLUDE THE PLURAL AND VICE VERSA, REFERENCES TO ATTACHMENTS ARE REFERENCES TO
ATTACHMENTS TO THIS AGREEMENT, AND REFERENCES TO ARTICLES AND SECTIONS ARE
REFERENCES TO THE ARTICLES AND SECTIONS OF THIS AGREEMENT.

 

2.             TERM.

 

2.1.          THIS AGREEMENT SHALL TAKE EFFECT AS OF THE EFFECTIVE DATE AND
SHALL REMAIN IN EFFECT UNTIL THE DELIVERY OF THE *****  BATCH, UNLESS EARLIER
TERMINATED AS PROVIDED FOR IN SECTION 2.2 BELOW OR ARTICLE 16 OR EXTENDED UNDER
AN AMENDMENT TO THIS AGREEMENT.

 

2.2           NOT WITHSTANDING ANY TERMS IN THIS AGREEMENT TO THE CONTRARY, THE
PARTIES AGREE, THAT IMCLONE MAY TERMINATE THIS AGREEMENT UPON SIX (6) MONTHS
PRIOR WRITTEN NOTICE, WITHOUT ANY FINANCIAL PENALTY, AT ANY TIME AFTER THE
COMPLETION OF THE MINIMUM ORDER.

 

3.             SUPPLY BY IMCLONE.

 

3.1.          SUPPLY OF CELL LINE AND REFERENCE STANDARD.  IMCLONE SHALL SUPPLY
OR CAUSE TO BE SUPPLIED, SUFFICIENT PURIFIED REFERENCE STANDARD FOR THE PRODUCT
AND SUFFICIENT AMPOULES OF THE CELL LINE FROM AN APPROPRIATE CELL BANK FOR LB TO
PROVIDE THE SERVICES.

 

3.2.          SUPPLY OF OTHER IMCLONE MATERIALS.  IMCLONE SHALL ENSURE THE
ADEQUATE AND TIMELY SUPPLY OF FURTHER AMOUNTS OF THE IMCLONE MATERIALS IN
SUFFICIENT QUANTITY TO FACILITATE LB’S PERFORMANCE OF THE SERVICES.  LB MUST
PROVIDE IMCLONE TIMELY NOTICE, IN WRITING, OF ITS REQUIREMENTS FOR IMCLONE
MATERIALS.

 

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[*****] 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.

 

11

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3.3.          RIGHTS IN IMCLONE INFORMATION, IMCLONE PATENT RIGHTS AND IMCLONE
MATERIALS.  IMCLONE HEREBY GRANTS LB THE NON-EXCLUSIVE RIGHT TO USE THE IMCLONE
INFORMATION, THE IMCLONE PATENT RIGHTS AND THE IMCLONE MATERIALS SOLELY FOR THE
PURPOSE OF LB PERFORMING SERVICES FOR IMCLONE UNDER THIS AGREEMENT.  WITHOUT
PREJUDICE TO ANY OTHER RIGHTS VESTED IN LB PURSUANT TO PRE-EXISTING OR FUTURE
AGREEMENTS BETWEEN THE PARTIES OR THEIR AFFILIATES, LB WILL NOT USE THE IMCLONE
INFORMATION, IMCLONE PATENT RIGHTS OR IMCLONE MATERIALS (OR ANY PART THEREOF)
FOR ANY OTHER PURPOSE WITHOUT IMCLONE’S PRIOR WRITTEN CONSENT.  EXCEPT AS SET
FORTH IN THIS SECTION 3.3, NO LICENSES ARE GRANTED TO LB TO USE THE IMCLONE
MATERIALS, THE IMCLONE PATENT RIGHTS OR THE IMCLONE INFORMATION, AND NO LICENSES
SHALL ARISE OR BE DEEMED TO HAVE ARISEN BY DEFAULT, ESTOPPEL OR OTHERWISE.

 

3.4.          LB OBLIGATIONS REGARDING IMCLONE MATERIALS.  LB SHALL:

 

3.4.1.       AT ALL TIMES USE ALL REASONABLE ENDEAVORS TO KEEP THE IMCLONE
MATERIALS AND RAW MATERIALS SECURE AND SAFE FROM LOSS AND DAMAGE IN SUCH MANNER
AS LB STORES ITS OWN MATERIALS OF SIMILAR NATURE;

 

3.4.2.       NOT PART WITH POSSESSION OF THE IMCLONE MATERIALS OR THE PRODUCT,
SAVE FOR THE PURPOSE OF TESTS AT THE TESTING LABORATORIES OR AS DIRECTED BY
IMCLONE; AND

 

3.4.3.       CAUSE ALL TESTING LABORATORIES TO BE SUBJECT TO CONFIDENTIALITY AND
LIMITED-USE OBLIGATIONS NO LESS ONEROUS THAN THOSE CONFIDENTIALITY AND
LIMITED-USE OBLIGATIONS IMPOSED ON LB UNDER THIS AGREEMENT.

 

3.5.          NO OTHER LICENSE.  WITHOUT PREJUDICE TO LB’S RIGHT TO RECEIVE
PAYMENT OF THE PRICE HEREUNDER OR TO LB’S OWN PROPRIETARY RIGHTS IN THE LB
INFORMATION AND THE LB PATENT RIGHTS, LB AGREES THAT, EXCEPT AS EXPRESSLY
PROVIDED IN SECTION 3.3 ABOVE, LB SHALL NOT BY VIRTUE

 

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[*****] 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.

 

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OF THIS AGREEMENT ACQUIRE ANY RIGHT, LICENSE OR TITLE IN, OR TO, THE IMCLONE
PATENT RIGHTS, THE IMCLONE INFORMATION, THE IMCLONE MATERIALS, THE 5000 LITER
PROCESS, OR THE PRODUCT.

 

3.6.          IMCLONE REPRESENTATIONS AND WARRANTIES.  PROVIDED THAT THE PRODUCT
IS IMC-C225, THEN IMCLONE REPRESENTS AND WARRANTS TO LB AS FOLLOWS: (IF A
DIFFERENT PRODUCT IS TO BE PRODUCED, IMCLONE AGREES TO MAKE NEW REPRESENTATIONS
AND WARRANTIES REGARDING SUCH PRODUCT AND BOTH PARTIES AGREE TO NEGOTIATE IN
GOOD FAITH SUCH NEW REPRESENTATIONS AND WARRANTIES WITH THE GOAL THAT SUCH NEW
REPRESENTATIONS AND WARRANTIES WILL SATISFY, WHENEVER PRACTICABLE, THE INTENT OF
THIS SECTION 3.6.)

 

3.6.1.       IMCLONE HAS THE CORPORATE POWER AND AUTHORITY TO ENTER INTO THIS
AGREEMENT;

 

3.6.2.       TO THE BEST OF IMCLONE’S KNOWLEDGE AND BELIEF, IMCLONE HAS, AND
SUBJECT TO SECTION 3.6.5 BELOW, SHALL AT ALL TIMES THROUGHOUT THE TERM OF THIS
AGREEMENT HAVE, THE RIGHT TO SUPPLY THE CELL LINE, THE OTHER IMCLONE MATERIALS
AND THE IMCLONE INFORMATION TO LB;

 

3.6.3.       ANY OF THE CELL LINE, THE OTHER IMCLONE MATERIALS, IMCLONE
INFORMATION AND IMCLONE PATENT RIGHTS NOT OWNED BY IMCLONE ARE LICENSED TO
IMCLONE UNDER A LICENSE WHICH WILL PERMIT THEIR USE BY LB TO PERFORM THE
SERVICES;

 

3.6.4.       TO THE BEST OF IMCLONE’S KNOWLEDGE AND BELIEF, THE USE BY LB OF THE
CELL LINE, OTHER IMCLONE MATERIALS, IMCLONE INFORMATION, IMCLONE PATENT RIGHTS
AND THE LARGE SCALE PROCESS (EXCLUDING ANY STEPS MADE OR DEVELOPED BY LB) FOR
THE SERVICES WILL NOT INFRINGE ANY RIGHTS (INCLUDING, WITHOUT LIMITATION, ANY
INTELLECTUAL PROPERTY RIGHTS) OF ANY THIRD PARTY; AND

 

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[*****] 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.

 

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3.6.5.       EXCEPT AS TO ALLEGED INFRINGEMENT ACTIONS DISCLOSED ON
SCHEDULE 3.6, IMCLONE WILL PROMPTLY NOTIFY LB IN WRITING IF IT IS NO LONGER
ENTITLED TO SUPPLY THE CELL LINE, OTHER IMCLONE MATERIALS, IMCLONE INFORMATION
OR THE IMCLONE PATENTS FOR THE SERVICES OR IF IMCLONE IS AWARE THAT THE USE
THEREOF INFRINGES OR IS ALLEGED TO INFRINGE ANY RIGHTS (INCLUDING, WITHOUT
LIMITATION, ANY INTELLECTUAL PROPERTY RIGHTS) OF ANY THIRD PARTY.

 

3.6.6.       TO IMCLONE’S KNOWLEDGE, IMCLONE HAS DISCLOSED, AND SHALL DISCLOSE,
TO LB ALL ENVIRONMENTAL REQUIREMENTS THAT IMCLONE IS AWARE OF OR BECOMES AWARE
OF, WITHOUT INDEPENDENT INVESTIGATION BY IMCLONE, WHICH LB MUST COMPLY WITH
DURING THE USE OF THE 5000 LITER PROCESS (EXCLUDING ANY STEPS MADE OR DEVELOPED
BY LB).

 

3.7.          IMCLONE IP INDEMNIFICATION.  IMCLONE WILL INDEMNIFY, DEFEND AND
HOLD HARMLESS LB AND ITS AFFILIATES AGAINST ANY LOSS, DAMAGE, COSTS AND EXPENSES
OF ANY NATURE (INCLUDING REASONABLE FEES AND DISBURSEMENTS OF COUNSEL AND
EXPERTS) INCURRED BY LB OR ANY AFFILIATE OF LB OR ORDERED BY A COURT OF
COMPETENT JURISDICTION TO BE PAID OR PAYABLE BY LB OR ANY AFFILIATE OF LB, TO
THE EXTENT INCURRED AS THE RESULT OF (A) ANY BREACH OF THE WARRANTIES SET FORTH
IN SECTION 3.6 ABOVE OR (B) ANY CLAIMS (COLLECTIVELY, “LB CLAIMS”) ALLEGING LB’S
USE OF THE CELL LINE, OTHER IMCLONE MATERIALS, THE IMCLONE INFORMATION, IMCLONE
PATENT RIGHTS OR THE 5000 LITER PROCESS (OTHER THAN STEPS OR COMPONENTS WHICH
ARE OR BECOME PART OF THE 5000 LITER PROCESS BY VIRTUE OF CONTRIBUTIONS OF LB)
IN THE COURSE OF THE SERVICES, INFRINGES OR IS ALLEGED TO INFRINGE ANY RIGHTS
(INCLUDING WITHOUT LIMITATION ANY INTELLECTUAL PROPERTY RIGHTS) OF A THIRD PARTY
(WHETHER OR NOT IMCLONE KNOWS OR OUGHT TO HAVE KNOWN OF SUCH INFRINGEMENT OR
ALLEGED INFRINGEMENT).  ANY LOST BATCH PRICE SHALL BE INCLUDED IN THE LOSSES AND
DAMAGES RESULTING FROM ANY SUCH BREACH OR CLAIM. 

 

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IT IS HEREBY AGREED THAT LB SHALL NOTIFY IMCLONE AS SOON AS IS REASONABLY
PRACTICABLE OF ANY CLAIM, ACTION OR PROCEEDINGS AND SHALL AT IMCLONE’S COST
PROVIDE IMCLONE WITH REASONABLE ASSISTANCE AND RELEVANT INFORMATION TO SUPPORT
IMCLONE TO AVOID, COMPROMISE OR DEFEND ANY SUCH CLAIM OR ACTION OR PROCEEDINGS. 
FURTHER, UNLESS THE SAME CONFLICT WITH OR PREJUDICE LB’S PROPER BUSINESS
INTERESTS OR MIGHT REASONABLY BE EXPECTED TO DO SO LB SHALL AT IMCLONE’S COST
TAKE SUCH ACTION AS IMCLONE MAY REASONABLY AND PROPERLY REQUIRE TO AVOID,
COMPROMISE OR DEFEND ANY SUCH CLAIM OR ACTION OR PROCEEDINGS. NOTHING CONTAINED
IN THIS SECTION 3.7 SHALL OBLIGE LB TO TAKE ANY ACTION OR STEPS IN ITS OWN NAME
IN DEFENDING ANY CLAIM, ACTION OR PROCEEDINGS.  THE PROVISIONS OF THIS
SECTION 3.7 SHALL BE LB’S SOLE AND EXCLUSIVE REMEDY IN CONNECTION WITH THE
MATTERS DESCRIBED IN CLAUSES (A) AND (B) ABOVE.

 

3.8.          SURVIVAL.  THE OBLIGATIONS OF IMCLONE UNDER SECTION 3.7 SHALL
SURVIVE THE END OF THE TERM OR EARLIER TERMINATION OF THIS AGREEMENT.

 

4.             AGREEMENT TO SUPPLY.

 

4.1.          CGMP MANUFACTURE.  LB WILL, IN ACCORDANCE WITH THE TERMS OF THIS
AGREEMENT, MANUFACTURE AND DELIVER (IN ACCORDANCE WITH SECTION 7.1) BATCHES OF
PRODUCT AT 5000 LITER SCALE IN ACCORDANCE WITH CGMP USING THE 5000 LITER PROCESS
AND THE 5000 LITER MANUFACTURING SUITE.  IMCLONE UNDERSTANDS THAT AS FURTHER
DEFINED IN SECTION 4.3 ADDITIONAL PRODUCT-SPECIFIC DEVELOPMENT DOCUMENTATION AND
VALIDATION WORK MAY BE REQUIRED TO SUPPORT REGULATORY APPLICATIONS.

 

4.1.1        IMCLONE ACKNOWLEDGES AND AGREES TO ORDER THE MINIMUM ORDER AS
DEFINED HEREIN, PROVIDED THAT LB PASSES ALL RELEVANT REGULATORY AUTHORITY AND
CGMP INSPECTIONS OF LB’S FACILITY TO MANUFACTURE 5000L BATCHES OF PRODUCT.

 

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4.1.2        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

 

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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

 

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ADDITIONAL ORDERS SHALL BE SUBJECT TO LB’S FREELY AVAILABLE CAPACITY IN THE
5000L SUITE AS DETERMINED SOLELY BY LB.

 

5.3.          BINDING ORDER.  NOT LATER THAN SIX (6) MONTHS PRIOR TO OUT OF
FREEZE OF ANY CAMPAIGN, IMCLONE SHALL CONFIRM THE ACTUAL NUMBER OF BATCHES IT
REQUIRES FOR MANUFACTURE. UPON LB’S ACCEPTANCE OF THAT CONFIRMED NUMBER OF
BATCHES A “BINDING ORDER” SHALL ARISE FOR THAT NUMBER OF BATCHES.

 

6.             PROVISION OF THE SERVICES.

 

6.1.          DILIGENCE.  LB SHALL DILIGENTLY CARRY OUT THE SERVICES IN A
PROFESSIONAL AND WORKMAN-LIKE MANNER, CONSISTENT WITH INDUSTRY STANDARDS FOR THE
CONTRACT MANUFACTURING OF BIOLOGICS.

 

6.2.          THIS SECTION LEFT INTENTIONALLY BLANK.

 

6.3.          CANCELLATIONS.

 

 IMCLONE MAY CANCEL BATCHES UNDER THE MINIMUM ORDER ON WRITTEN NOTICE TO LB
SUBJECT TO THE FOLLOWING CANCELLATION FEES:

 

6.3.1        ***** OF THE BATCH PRICE FOR ALL SUCH BATCHES CANCELLED WITHIN 6
MONTHS OF COMMENCEMENT DATE OF THE BATCHES.

 

6.3.2        *****  OF THE BATCH PRICE FOR ALL SUCH BATCHES CANCELLED BETWEEN
THE PERIOD SEVEN (7) TO TWELVE (12) MONTHS OF COMMENCEMENT DATE OF THE BATCHES.

 

6.3.3        *****  OF THE BATCH PRICE FOR ALL SUCH BATCHES CANCELLED AT GREATER
THAN 12 MONTHS PRIOR TO THE COMMENCEMENT DATE OF THE BATCHES.

 

6.3.4        FOR THE AVOIDANCE OF DOUBT IMCLONE MAY NOT CANCEL ANY BATCH THAT
HAS COMMENCED MANUFACTURE

 

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6.3.5        FOR THE AVOIDANCE OF DOUBT FOR ANY BINDING ORDER OR CONTRACT ORDER
IN EXCESS OF THE MINIMUM ORDER, IMCLONE MAY CANCEL ANY BATCH UPON SIX (6) MONTHS
PRIOR WRITTEN NOTICE, WITHOUT ANY FINANCIAL PENALTY, PROVIDED THAT THE BATCH
COMMENCEMENT DATE FOR THE CANCELED BATCH IS AT LEAST SIX (6) MONTHS AWAY.

 

6.3.6        NOTWITHSTANDING THE FOREGOING, IF IMCLONE CANCELS OR RESCHEDULES A
BATCH, LB WILL USE GOOD FAITH EFFORTS TO SEEK AN ALTERNATIVE CUSTOMER OR
CUSTOMERS TO PURCHASE THE CAPACITY WHICH IS RESERVED FOR IMCLONE SO AS TO
MITIGATE IMCLONE’S OBLIGATIONS UNDER THE AGREEMENT.  IF LB IS ABLE TO SELL SUCH
CAPACITY, IMCLONE’S OBLIGATION TO COMPENSATE LB PURSUANT TO SECTION 6.3 SHALL BE
ADJUSTED ACCORDINGLY.

 

6.4           EXCEPT AS PROVIDED IN THIS ARTICLE 6 OR SECTION 17.4, IMCLONE
SHALL NOT BE ENTITLED TO CANCEL ANY UNFULFILLED PART OF THE SERVICES OR TO
REFUSE TO ACCEPT THE SERVICES ON GROUNDS OF LATE PERFORMANCE, LATE DELIVERY OR
FAILURE TO PRODUCE THE ESTIMATED QUANTITIES OF PRODUCT FOR DELIVERY.  LB SHALL
NOT, EXCEPT AS PROVIDED IN THIS ARTICLE 6, BE LIABLE FOR ANY LOSS, DAMAGE, COSTS
OR EXPENSES OF ANY NATURE, WHETHER DIRECT OR CONSEQUENTIAL, OCCASIONED BY:

 

6.4.1.       ANY DELAY IN PERFORMANCE OR DELIVERY HOWSOEVER CAUSED; OR

 

6.4.2.       ANY FAILURE TO PRODUCE THE ESTIMATED QUANTITIES OR NUMBER OF
BATCHES OF PRODUCT FOR DELIVERY.

 

6.5.          THIS SECTION LEFT INTENTIONALLY BLANK

 

6.6.          THIS SECTION LEFT INTENTIONALLY BLANK

 

6.7.          TARGET BATCH YIELD.  IMCLONE AND LB EACH ACKNOWLEDGE THAT, DUE TO
THE UNPREDICTABLE NATURE OF BIOLOGICAL PROCESSES, 5000 LITER PROCESS PRODUCT
YIELD CANNOT BE

 

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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

 

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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 IN COMPLYING WITH
IMCLONE’S REQUESTS REGARDING THE REQUIREMENTS REFERRED TO IN SECTIONS 6.9.1
THROUGH 6.9.3 SHALL BE CHARGED TO IMCLONE, IN ADDITION TO THE PRICE.

 

6.10.        LATE DELIVERY.

 

6.10.1.     WHERE A BATCH HAS BEEN ORDERED BY IMCLONE PURSUANT TO SECTION 5.2
AND IS SUBJECT TO AN AGREED DATE FOR DELIVERY AND LB FAILS TO DELIVER SAID BATCH
BY A DATE WHICH IS SIX (6) WEEKS AFTER SUCH DATE FOR DELIVERY (SUBJECT TO AN
EXTENSION OF TIME FOR SUCH DELIVERY WHICH LB MAY BECOME ENTITLED TO HEREUNDER)
PRINCIPALLY DUE TO LB’S OWN FAULT, OMISSION OR UNILATERAL SCHEDULING CHANGE,
IMCLONE SHALL BE ENTITLED TO CLAIM COMPENSATION FOR SUCH LATE DELIVERY.  THE
COMPENSATION TO WHICH IMCLONE SHALL BECOME ENTITLED SHALL BE EQUIVALENT TO FIVE
PERCENT (5%) OF THE PRICE OF THE BATCH IN QUESTION MULTIPLIED BY THE NUMBER OF
WEEKS (OR FRACTIONS OF WEEKS),

 

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BETWEEN THE DATE SIX (6) WEEKS AFTER THE DATE FOR THE BATCH IN QUESTION AND THE
NEXT DATE UPON WHICH A BATCH IS NOTIFIED TO IMCLONE AS BEING READY FOR DELIVERY.

 

6.10.2.     LIMITATION ON LIABILITY.  IN NO EVENT SHALL COMPENSATION PURSUANT TO
THIS SECTION 6.10 ON ANY ONE BATCH EXCEED THIRTY FIVE PERCENT (35%) OF THE PRICE
OF THE BATCH IN QUESTION, IRRESPECTIVE OF WHETHER SUCH DAMAGES ACCRUE AS A
RESULT OF ANY SINGLE EVENT OR A SERIES OF EVENTS OR AS A CONSEQUENCE OF DELAY TO
DELIVERY OF A PREVIOUS BATCH.  SUCH LIQUIDATED DAMAGES ARE A REASONABLE ESTIMATE
OF ACTUAL DAMAGES AND DO NOT REPRESENT A PENALTY. NOTWITHSTANDING THE FOREGOING,
WHERE LATE DELIVERY COMPENSATION HAS ACCRUED ON A PARTICULAR BATCH DURING A
CAMPAIGN, AND AS A CONSEQUENCE, OTHER BATCHES ORDERED IN THE SAME CAMPAIGN ARE
ALSO DELAYED, IMCLONE SHALL BE ENTITLED TO CLAIM COMPENSATION IN RESPECT OF SUCH
DELAY ON NO MORE THAN THE FIRST TWO (2) OF SUCH DELAYED BATCHES IN ANY CAMPAIGN.

 

7.             DELIVERY AND TRANSPORTATION OF PRODUCT; IMCLONE TESTS.

 

7.1.          DELIVERY.  THE PRODUCT SHALL BE DELIVERED EXW (EX-WORKS AS DEFINED
BY INCOTERMS 2000) LB (NH)’S PORTSMOUTH, NEW HAMPSHIRE MANUFACTURING FACILITY
(“DELIVER,” “DELIVERY,” OR “DELIVERED,” AS APPROPRIATE).  LB SHALL ISSUE TO
IMCLONE A CERTIFICATE OF ANALYSIS ON OR BEFORE THE DELIVERY DATE.

 

7.2.          PACKAGING AND LABELING.  UNLESS OTHERWISE AGREED, LB WILL PACKAGE
AND LABEL PRODUCT IN ACCORDANCE WITH ITS STANDARD OPERATING PROCEDURES.  IMCLONE
WILL INFORM LB IN WRITING IN ADVANCE OF ANY SPECIAL PACKAGING AND LABELING
REQUIREMENTS FOR THE PRODUCT.  ALL

 

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ADDITIONAL COSTS AND EXPENSES INCURRED BY LB IN COMPLYING WITH SUCH SPECIAL
REQUIREMENTS SHALL BE CHARGED TO IMCLONE IN ADDITION TO THE PRICE.

 

7.3.          LOADING, INSURANCE AND TRANSPORTATION.  IMCLONE SHALL PICK UP THE
PRODUCT WITHIN FOURTEEN (14) DAYS AFTER THE DELIVERY DATE.  NOTWITHSTANDING THE
DELIVERY OF PRODUCT EXW, LB SHALL LOAD THE PRODUCT AT LB’S EXPENSE ONTO THE
TRUCKS PROVIDED BY IMCLONE, AT IMCLONE’S EXPENSE.  AT IMCLONE’S REQUEST AND
EXPENSE, LB WILL (ACTING AS AGENT FOR IMCLONE) ARRANGE FOR INSURANCE TO COVER
THE PRODUCT AFTER SUCH FOURTEEN (14) DAY PERIOD.  AT IMCLONE’S WRITTEN REQUEST
AND EXPENSE, LB WILL (ACTING AS AGENT FOR IMCLONE) ARRANGE THE TRANSPORTATION OF
PRODUCT TO A FACILITY IN THE UNITED STATES DESIGNATED BY IMCLONE, TOGETHER WITH
INSURANCE FOR THE PRICE FOR THE RELEVANT BATCH(ES) OF PRODUCT. ALL ADDITIONAL
COSTS AND EXPENSES INCURRED BY LB IN ARRANGING TRANSPORTATION AND INSURANCE
SHALL BE CHARGED TO IMCLONE IN ADDITION TO THE PRICE. IN CASES WHERE IMCLONE HAS
NOT REQUESTED LB TO ARRANGE FOR TRANSPORTATION OF PRODUCT, LB WILL PROVIDE
REASONABLE COOPERATION WITH IMCLONE’S TRANSPORTATION AGENTS IN COORDINATING THE
COLLECTION OF PRODUCT FROM LB (NH)’S PORTSMOUTH, NEW HAMPSHIRE FACILITY. 
TRANSPORTATION OF THE PRODUCT, WHETHER OR NOT UNDER ANY ARRANGEMENTS MADE BY LB
ON BEHALF OF IMCLONE, SHALL BE MADE AT THE SOLE RISK AND EXPENSE OF IMCLONE. FOR
THE AVOIDANCE OF DOUBT, THE PRODUCT WILL NOT BE INSURED BY LB AFTER THE ABOVE
REFERENCED FOURTEEN (14) DAY PERIOD UNLESS OTHERWISE ARRANGED FOR.

 

7.4.          QUARANTINE OF PRODUCT.  AT IMCLONE’S REQUEST, LB WILL DELIVER
PRODUCT BATCHES IN QUARANTINE PRIOR TO DELIVERY OF THE CERTIFICATE OF ANALYSIS. 
SUCH REQUEST SHALL BE ACCOMPANIED BY IMCLONE’S WRITTEN ACKNOWLEDGEMENT THAT THE
BATCH HAS BEEN DELIVERED WITHOUT THE TRANSMITTAL TO IMCLONE OF A CERTIFICATE OF
ANALYSIS, THAT ACCORDINGLY THE BATCH CANNOT BE ADMINISTERED TO HUMANS UNTIL
TRANSMITTAL OF THE CERTIFICATE OF ANALYSIS, AND THAT IMCLONE NEVERTHELESS
ACCEPTS FULL RISK OF LOSS, TITLE AND OWNERSHIP OF THE BATCH WHEN DELIVERED.  THE
DELIVERY OF A BATCH IN

 

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QUARANTINE SHALL BE SUBJECT TO SUCH TESTING REQUIREMENTS AS LB OR IMCLONE MAY
REASONABLY REQUIRE, AND THE SIXTY (60) DAY PERIOD REFERRED TO IN SECTION 7.6
SHALL RUN FROM RECEIPT IN QUARANTINE BY IMCLONE OF THE RELEVANT BATCHES.

 

7.5.          INSPECTION OF PRODUCT.  WHERE LB HAS MADE ARRANGEMENTS FOR THE
TRANSPORTATION OF PRODUCT UNDER SECTION 7.3, LB SHALL USE ITS REASONABLE
ENDEAVORS TO NOTIFY IMCLONE BY FACSIMILE OF SHIPMENT ON THE DATE OF DISPATCH. 
IMCLONE SHALL DILIGENTLY EXAMINE THE PRODUCT AS SOON AS PRACTICABLE AFTER
RECEIPT.  NOTICE OF ALL CLAIMS ARISING OUT OF:

 

7.5.1.       DAMAGE TO OR TOTAL OR PARTIAL LOSS OF PRODUCT IN TRANSIT SHALL BE
GIVEN IN WRITING TO LB AND THE CARRIER WITHIN FIVE (5) BUSINESS DAYS OF
DELIVERY; OR

 

7.5.2.       FAILURE OF A SHIPMENT OF PRODUCT TO ARRIVE SHALL BE GIVEN IN
WRITING WITHIN TEN (10) BUSINESS DAYS OF THE DATE ON WHICH THE SHIPMENT WAS
MADE, AS STATED IN LB’S NOTICE OF SHIPMENT PROVIDED IN ACCORDANCE WITH THE TERMS
ABOVE TO IMCLONE.

 

ImClone shall make damaged Product available for inspection and shall comply
with the requirements of any insurance policy covering the Product.  LB shall
offer ImClone all reasonable assistance, at ImClone’s cost, in pursuing any
claims arising out of the transportation of Product, but LB’s responsibility
shall otherwise be limited by the EXW shipping term (Incoterms 2000).

 

7.6.          TESTS.  PROMPTLY FOLLOWING RECEIPT OF A BATCH OF PRODUCT, OR ANY
SAMPLE INTENDED TO BE REPRESENTATIVE THEREOF, IMCLONE SHALL CARRY OUT THE
IMCLONE TESTS.  IF THE IMCLONE TESTS SHOW THAT THE PRODUCT FAILS TO MEET THE
APPLICABLE SPECIFICATIONS, THEN IMCLONE SHALL GIVE LB WRITTEN NOTICE THEREOF
WITHIN SIXTY (60) DAYS FROM THE DATE OF RECEIPT OF THE BATCH OR SAMPLE AND
SHALL, UNLESS OTHERWISE DIRECTED BY LB, RETURN THE BATCH OR SAMPLE FOR FURTHER
TESTING.  IN THE

 

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ABSENCE OF SUCH WRITTEN NOTICE, THE BATCH SHALL BE DEEMED TO HAVE BEEN ACCEPTED
BY IMCLONE AS MEETING SPECIFICATIONS.  IF LB AGREES, OR IT IS DETERMINED
PURSUANT TO SECTION 7.7, THAT THE RETURNED BATCH OR SAMPLE FAILS TO MEET
SPECIFICATIONS AND, TO THE EXTENT THAT SUCH FAILURE IS NOT DUE (IN WHOLE OR IN
PART) TO ACTS OR OMISSIONS OF IMCLONE OR ANY THIRD PARTY AFTER DELIVERY OF SUCH
BATCH, THE BATCH IN QUESTION SHALL BE REGARDED AS NOT HAVING BEEN DELIVERED
IMCLONE SHALL BE ENTITLED TO A CREDIT IN RESPECT OF ANY BATCH PRICE ASSOCIATED
WITH SUCH BATCH.

 

7.7.          DISPUTES.  IF THERE IS ANY DISPUTE CONCERNING WHETHER A BATCH
MEETS THE APPLICABLE SPECIFICATIONS AND/OR THE REASONS THEREFORE, SUCH DISPUTE
SHALL BE REFERRED FOR DECISION TO AN INDEPENDENT EXPERT (ACTING AS AN EXPERT AND
NOT AS AN ARBITRATOR) TO BE APPOINTED BY AGREEMENT BETWEEN LB AND IMCLONE OR, IN
THE ABSENCE OF AGREEMENT BY OPERATION OF THE PROVISIONS OF SECTION 19.2.  THE
COSTS OF SUCH INDEPENDENT EXPERT SHALL BE BORNE EQUALLY BETWEEN LB AND IMCLONE. 
THE DECISION OF SUCH INDEPENDENT EXPERT SHALL BE IN WRITING AND, SAVE FOR
MANIFEST ERROR ON THE FACE OF THE DECISION, SHALL BE BINDING ON BOTH LB AND
IMCLONE.

 

8.             STEERING COMMITTEE.

 

8.1.          COMPOSITION OF STEERING COMMITTEE.  PROMPTLY FOLLOWING THE
EFFECTIVE DATE, LB AND IMCLONE SHALL ESTABLISH A STEERING COMMITTEE.  THE
STEERING COMMITTEE SHALL BE COMPRISED OF EQUAL NUMBERS OF REPRESENTATIVES OF
EACH PARTY (NOT TO EXCEED THREE REPRESENTATIVES OF EACH PARTY).  IMCLONE’S
REPRESENTATIVES MAY INCLUDE EMPLOYEES AND REPRESENTATIVES OF IMCLONE’S
COMMERCIAL PARTNER FOR SUCH PRODUCT.

 

8.2.          FUNCTION OF STEERING COMMITTEE.  WITHOUT LIMITING THE FUNCTIONS OF
THE STEERING COMMITTEE SET OUT ELSEWHERE IN THIS AGREEMENT, THE ROLE OF THE
STEERING COMMITTEE SHALL BE TO:

 

8.2.1.       THIS SECTION LEFT INTENTIONALLY BLANK

 

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8.2.2.       ASSESS THE STATUS OF 5000 LITER PROCESS AND SUBSTITUTE PRODUCTS FOR
INTRODUCTION INTO THE 5000 LITER MANUFACTURING SUITE IN CONNECTION WITH THE
SERVICES AND MONITOR THE STATUS OF OPERATION OF THE 5000 LITER MANUFACTURING
SUITE;

 

8.2.3.       THIS SECTION LEFT INTENTIONALLY BLANK

 

8.2.4.       RESOLVE DISPUTES ARISING BETWEEN THE PARTIES UNDER THIS AGREEMENT,
AS PROVIDED IN SECTION 19.2,

 

8.2.5.       MONITOR THE PROGRESS OF THE SERVICES;

 

8.2.6.       ASSIST IMCLONE IN PLANNING AND ASSESSING IMCLONE’S NEEDS FOR FUTURE
SUPPLY OF PRODUCT;

 

8.2.7.       DISCUSS AND RECOMMEND ANY CHANGES TO THE 5000 LITER PROCESS OR
SPECIFICATIONS, SUBJECT TO ARTICLE 9;

 

8.2.8.       THIS SECTION LEFT INTENTIONALLY BLANK

 

8.3.          MEETINGS.  THE STEERING COMMITTEE SHALL MEET AT SUCH TIMES AS THE
STEERING COMMITTEE DETERMINES TO RESOLVE ISSUES ARISING UNDER AND TO PERFORM ITS
RESPONSIBILITIES UNDER THIS AGREEMENT, PROVIDED THAT THE STEERING COMMITTEE
SHALL MEET NOT LESS THAN TWO (2) TIMES PER CALENDAR YEAR UNLESS OTHERWISE
MUTUALLY AGREED.  IF ANY ISSUE TO BE DETERMINED BY THE STEERING COMMITTEE IS NOT
RESOLVED WITHIN THIRTY (30) DAYS AFTER SUBMISSION OF THE RELEVANT ISSUE TO THE
STEERING COMMITTEE, SUCH ISSUE SHALL BE REFERRED FOR RESOLUTION TO THE PRESIDENT
OR THE MOST SENIOR MANUFACTURING OFFICER OF IMCLONE AND THE SENIOR OFFICER OF LB
BIOLOGICS INC. (TOGETHER, THE “PRESIDENTS”).

 

8.4.          LIMITATIONS.  THE STEERING COMMITTEE IS NOT EMPOWERED TO AMEND THE
TERMS OF THIS AGREEMENT.

 

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9.             PROCESS CHANGES.

 

9.1.          5000 LITER PROCESS.  LB SHALL NOT UNREASONABLY REFUSE ANY WRITTEN
REQUEST FROM IMCLONE TO MAKE CHANGES TO THE 5000 LITER PROCESS (FOR EXAMPLE,
CHANGES TO THE 5000 LITER PROCESS WHICH ARE REQUIRED BY THE PRODUCT OR AN
APPLICABLE REGULATORY AUTHORITY OR APPLICABLE LAWS), BUT NO CHANGE TO THE 5000
LITER PROCESS SHALL BE MADE EXCEPT BY AN AGREEMENT IN WRITING SIGNED BY THE
AUTHORIZED REPRESENTATIVES OF BOTH PARTIES.  NOTWITHSTANDING THE FOREGOING, THE
PARTIES AGREE TO MODIFY THE 5000 LITER PROCESS FOR ERBITUXÂ TO IMCLONE’S NEW
PROCESS KNOWN AS THE HIGH TITER PROCESS WHICH HAS BEEN PREVIOUSLY DISCLOSED AND
DISCUSSED BETWEEN THE PARTIES.

 

9.2.          SPECIFICATIONS.  LB SHALL NOT UNREASONABLY REFUSE ANY WRITTEN
REQUEST FROM IMCLONE TO MAKE CHANGES TO THE SPECIFICATIONS (FOR EXAMPLE, CHANGES
TO THE SPECIFICATIONS THAT ARE REQUIRED BY AN APPLICABLE REGULATORY AUTHORITY OR
APPLICABLE LAWS), BUT NO CHANGE TO SPECIFICATIONS SHALL BE MADE EXCEPT BY AN
AGREEMENT IN WRITING SIGNED BY THE AUTHORIZED REPRESENTATIVES OF BOTH PARTIES,
AS UNDER THE TERMS OF THE QUALITY AGREEMENT.

 

9.3.          PROCEDURE.  UNLESS A PARTY HAS DESIGNATED AN AUTHORIZED
REPRESENTATIVE BY NOTICE TO THE STEERING COMMITTEE, CHANGES TO 5000 LITER
PROCESS OR SPECIFICATIONS MUST BE APPROVED IN WRITING BY AN OFFICER OF THE PARTY
IN QUESTION.

 

9.4.          ADJUSTMENTS RESULTING FROM PROCESS AND SPECIFICATION CHANGES.  ANY
CHANGES TO THE 5000 LITER PROCESS OR TO THE SPECIFICATIONS SHALL BE IMPLEMENTED
ON TERMS AND CONDITIONS TO BE AGREED, WHICH MAY INCLUDE, BUT NOT BE LIMITED TO,
ADDITIONAL DEVELOPMENT SERVICES (TO BE PERFORMED ON TERMS TO BE AGREED UPON IN
GOOD FAITH), AND REASONABLE ADJUSTMENTS (WHICH MAY BE UPWARD OR DOWNWARD, AS
APPROPRIATE) TO THE BATCH PRICE PAYABLE FOR SERVICES.

 

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10.           SHARED MANUFACTURING.

 

10.1.        THE PARTIES INTEND THAT THE PRODUCT PRODUCED PURSUANT TO THIS
AGREEMENT WHICH IS APPROVED BY THE APPROPRIATE REGULATORY BODY FOR MARKETING OR
SALE SHALL BE MANUFACTURED UNDER A SHARED MANUFACTURING ARRANGEMENT AS DEFINED
IN “DRAFT GUIDANCE FOR INDUSTRY – CO-OPERATIVE MANUFACTURING ARRANGEMENTS FOR
LICENSED BIOLOGICALS, DEPARTMENT OF HEALTH AND HUMAN SERVICES, FOOD AND DRUG
ADMINISTRATION, CBER, AUGUST 1999”.  A LIST OF THE RESPONSIBILITIES OF EACH
PARTY UNDER SUCH AN ARRANGEMENT WILL BE SET FORTH IN ATTACHMENT 1 TO THIS
AGREEMENT.

 

11.           REGULATORY SUPPORT AND QUALITY ASSURANCE.

 

11.1.        REGULATORY SUPPORT AND AUDITS.  LB SHALL PROVIDE REGULATORY SUPPORT
TO IMCLONE (OR BRISTOL-MYERS SQUIBB COMPANY AND ITS WHOLLY OWNED SUBSIDIARIES
(“BMS”) IN COOPERATION WITH IMCLONE), INCLUDING ANNUAL UPDATES TO ANY DRUG
MASTER FILES, BIOLOGICS LICENSES AND OTHER MANUFACTURING OR MARKETING
APPLICATIONS AND APPROVALS APPLICABLE TO THE PRODUCT AND THE PREPARATION FOR AND
HOSTING OF INSPECTIONS BY THE U.S. FOOD AND DRUG ADMINISTRATION (OR OTHER
REGULATORY AUTHORITIES) OR IMCLONE (OR BMS, MERCK KGAA OR ANY OTHER COMMERCIAL
PARTNER IN COOPERATION WITH IMCLONE, SUBJECT TO THE COMPLETION OF APPROPRIATE
CDAS BETWEEN PARTIES) (IN THE CASE OF IMCLONE’S OR BMS’S INSPECTIONS, AT
MUTUALLY CONVENIENT TIMES).  IMCLONE SHALL BE ENTITLED TO CONDUCT, AND THE PRICE
HAS BEEN CALCULATED TO INCLUDE LB REGULATORY SUPPORT FOR, ONE (1) AUDIT (AT A
MUTUALLY CONVENIENT TIME) BY IMCLONE PERSONNEL OF UP TO THREE (3) DAYS PRIOR TO
COMMENCEMENT OF THE SERVICES AND, THEREAFTER, UP TO ONE (1) AUDIT (AT A MUTUALLY
CONVENIENT TIME) BY IMCLONE PERSONNEL OF UP TO THREE (3) DAYS EACH ON AN ANNUAL
BASIS WHILE THE AGREEMENT IS IN EFFECT.  IN ADDITION, LB SHALL PERMIT, AND THE
PRICE HAS BEEN FURTHER CALCULATED TO INCLUDE, (A) AN IMCLONE EMPLOYEE OR
CONSULTANT LOCATED AT THE 5000 LITER MANUFACTURING SUITE (I.E., A MAN-IN-PLANT),
AND (B) BATCH RECORD AUDITS OF EACH BATCH.  EXCEPT AS PROVIDED IN SECTION 11.4,
IF ADDITIONAL REGULATORY SUPPORT OR ANCILLARY DEVELOPMENT SERVICES ARE REQUIRED
BY IMCLONE AN

 

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ADDITIONAL CHARGE SHALL BE MADE TO IMCLONE AT LB’S STANDARD RATES FOR REGULATORY
SERVICES AND/OR ANCILLARY DEVELOPMENT SERVICES AND FOR DISBURSEMENTS AT THE TIME
THE REGULATORY AND/OR ANCILLARY DEVELOPMENT SERVICES ARE PERFORMED.  LB SHALL
INFORM IMCLONE OF SUCH CHARGE AND OBTAIN IMCLONE’S WRITTEN CONSENT TO SUCH
CHARGE BEFORE PROVIDING SUCH ADDITIONAL SUPPORT.  NOTWITHSTANDING ANYTHING TO
THE CONTRARY IN THE FOREGOING, LB ACKNOWLEDGES AND AGREES THAT AT IMCLONE’S
REQUEST SUCH PERSONNEL OF IMCLONE’S COMMERCIAL PARTNERS MAY ATTEND AND
PARTICIPATE IN, ON THE SAME TERMS AS IMCLONE PERSONNEL, ANY AND ALL SUCH
SCHEDULED AUDITS AND REGULATORY SUPPORT PROVIDED PURSUANT TO THIS SECTION 11.1
AND THAT THE PRICE HAS BEEN CALCULATED TO INCLUDE THESE AUDITS. NO MORE THAN
THREE (3) TOTAL PERSONNEL FROM IMCLONE AND IMCLONE’S COMMERCIAL PARTNERS
INVOLVED IN THESE AUDITS AT THE LB SITE.

 

11.2.        REGULATORY SUBMISSIONS.  IMCLONE SHALL ADVISE LB OF ANY REGULATORY
SUBMISSIONS REGARDING THE PRODUCT WHICH MAY REQUIRE RESPONSES FROM LB TO
QUESTIONS FROM THE REGULATORY AUTHORITIES IN A TIMELY FASHION, TAKING ACCOUNT OF
THE AMOUNT OF INFORMATION LB IS REQUIRED TO PROVIDE.

 

11.3.        AMENDMENTS.  IF LB IS REQUIRED TO AMEND THE WAY IT MANUFACTURES
(SUCH AMENDMENTS BEING ACCOMPLISHED IN ACCORDANCE WITH ARTICLE 9) OR TESTS THE
PRODUCT AS A RESULT OF A CHANGE IN ANY STATUTORY OR REGULATORY REQUIREMENT AFTER
THE EFFECTIVE DATE, IT SHALL USE ALL REASONABLE EFFORTS TO COMPLY WITH SUCH
REQUIREMENT.  IN THIS EVENT THE PARTIES SHALL NEGOTIATE IN GOOD FAITH ANY
APPROPRIATE REVISION TO THE PRICE TO REFLECT ADDITIONAL OR LESSER COSTS INCURRED
BY LB AND ANY APPROPRIATE REVISION TO THE TIME SCHEDULES FOR PROVIDING THE
PRODUCT.

 

11.4.        ADDITIONAL AUDITS.  IF IMCLONE CONDUCTS AN AUDIT OF THE 5000 LITER
MANUFACTURING SUITE PURSUANT TO ITS RIGHTS UNDER SECTION 11.1 AND, AS A RESULT
OF DEFAULT ON THE PART OF LB, IMCLONE HAS JUST CAUSE TO CONDUCT FURTHER AUDITS
IN ORDER TO SATISFY ITSELF AS TO THE MATTERS OF

 

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DEFAULT IN QUESTION, IMCLONE SHALL BE ENTITLED, WITHOUT ADDITIONAL PAYMENT TO
LB, TO CONDUCT ADDITIONAL AUDITS (AT MUTUALLY CONVENIENT TIMES) IN ORDER TO
SATISFY ITSELF OF THE MATTERS IN QUESTION.

 

12.           THIS SECTION LEFT INTENTIONALLY BLANK

 

13.           PRICE AND TERMS OF PAYMENT.

 

13.1.        PRICE FOR SERVICES.  IN CONSIDERATION FOR THE PERFORMANCE OF THE
SERVICES, IMCLONE WILL PAY LB THE PRICE SET FORTH BELOW:

 

13.1.1.     THE CURRENT BATCH PRICE SHALL BE $ ***** PER BATCH, TO INCLUDE THOSE
PILOT BATCHES *****. FOR CLARIFICATION THE ***** PER BATCH PRICE INCLUDES ALL
THE COSTS AND CHARGES ASSOCIATED WITH THE RELEVANT PRODUCT TECH TRANSFER.

 

Except as expressly provided for by the terms and conditions of this Agreement,
ImClone shall not be obliged to make any further payments in respect of the
Services.

 

13.2.        This section left intentionally blank.

 

13.3         LB shall have the right to adjust the batch Price in section 13.1.1
by:

 

13.3.1      an increase of ***** on the batch price for each additional day
required beyond day ***** in the 5000L Production Fermenter and a reduction of
***** on the batch price for each full day less than ***** in the 5000L
Production Fermenter.

 

13.3.2      an increase of ***** for each additional day in the purification
suite required beyond ***** and a reduction of ***** for each day less than
***** in the purification suite.

 

13.4.        IT IS UNDERSTOOD BETWEEN PARTIES THAT THE ESTIMATED COST OF THE
BILL OF MATERIAL (BOM) IS $225,000 PER BATCH. IN THE EVENT THAT THE BOM EXCEEDS
$250,000, FOR

 

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ANY BATCH, THEN THE ADDITIONAL COST FOR THE BOM SHALL BE CHARGED TO IMCLONE. IN
THE EVENT THAT THE BOM IS LESS THAN $200,000, FOR ANY BATCH, THEN THE DIFFERENCE
SHALL BE REFUNDED TO IMCLONE IN THE FINAL PAYMENT OF THAT BATCH.

 

13.5.        BATCH PRICE ADJUSTMENTS FOR EXCEPTIONAL ITEMS.  THE BATCH PRICE
SHALL BE CHANGED TO REFLECT THE COSTS OF EXCEPTIONAL ITEMS INCURRED BY LB IN THE
PERFORMANCE OF THE SERVICES THAT COULD NOT REASONABLY HAVE BEEN FORESEEN (FOR
EXAMPLE EXTREME COST FLUCTUATIONS OF REGIONAL UTILITIES) EXCLUDING COST OR
EXPENSE ITEMS ACCOUNTED FOR BY ADJUSTMENT OF THE BATCH PRICE AS A RESULT OF
CHANGES IN THE PRODUCER PRICE INDEX.  THESE SHALL INCLUDE, BUT NOT BE LIMITED TO
CHANGES IN THE BATCH PRICE CAUSED BY MUTUALLY AGREED ALTERATION OF A 5000 LITER
PROCESS OR SPECIFICATIONS, PROVIDED THAT, IN EACH CASE, IMCLONE HAS RECEIVED A
WRITTEN ESTIMATE OF THE INCREASE IN COSTS AND A REASONABLE DEMONSTRATION OF THE
ITEMS OF COST OR EXPENSE IN QUESTION.  SUCH ADDITIONAL BATCH PRICE CHANGES SHALL
BE MADE AS NEEDED AND AGREED BY THE STEERING COMMITTEE.

 

13.6.        PAYMENT OF BATCH PRICE. IMCLONE SHALL PAY LB THE BATCH PRICE
AGAINST LB’S INVOICES THEREFORE, AS FOLLOWS:

 

13.6.1.     LB SHALL INVOICE IMCLONE FOR FIFTY PERCENT (50%) OF THE BATCH PRICE
UPON COMMENCEMENT OF WORK (OUT OF FREEZE) ON A BATCH BY RECOVERY OF AN AMPOULE
OF THE CELL LINE FROM THE WORKING CELL BANK; AND

 

13.6.2.     LB SHALL INVOICE IMCLONE FOR THIRTY PERCENT (30%) OF THE BATCH PRICE
UPON BULK FILL.

 

13.6.3.     LB SHALL INVOICE IMCLONE THE FINAL TWENTY PERCENT (20%) OF THE BATCH
PRICE UPON DELIVERY OF THE CERTIFICATE OF ANALYSIS AND MAKING THE BATCH RECORDS
AVAILABLE FOR REVIEW, INCLUDING LB’S FINAL RESPONSE TO IMCLONE’S COMMENTS AND
QUESTIONS ON THE BATCH RECORD FOR SUCH BATCH OF

 

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PRODUCT.  NOTWITHSTANDING THE FOREGOING IMCLONE AGREES TO PRESENT SUCH COMMENTS
AND QUESTIONS WITHIN 30 DAYS OF RECEIPT OF SUCH BATCH RECORD SUMMARY.

 

13.7.        THIS SECTION LEFT INTENTIONALLY BLANK

 

13.8.        Price for Undelivered Product.  No Batch Price shall be payable in
respect of Services that do not result in Delivery (in accordance with Section
7.1) of a Batch of Product, unless otherwise agreed by the Steering Committee.

 

13.9.        THIS SECTION LEFT INTENTIONALLY BLANK

 

13.10.      TAXES.  UNLESS OTHERWISE INDICATED IN WRITING BY LB, ALL PRICES AND
CHARGES ARE EXCLUSIVE OF ANY OTHER TAXES, LEVIES, IMPOSTS, DUTIES AND FEES OF
WHATEVER NATURE IMPOSED BY OR UNDER THE AUTHORITY OF ANY GOVERNMENT OR PUBLIC
AUTHORITY IN RESPECT OF THE SERVICES AND DELIVERY OF PRODUCT (OTHER THAN TAXES
ON LB’S INCOME), WHICH SHALL BE PAID BY IMCLONE.

 

13.11.      INVOICES.  ALL INVOICES ARE STRICTLY NET AND PAYMENT MUST BE MADE
WITHIN THIRTY (30) DAYS OF DATE OF INVOICE.  PAYMENT SHALL BE MADE WITHOUT
DEDUCTION, SET-OFF, LIEN OR COUNTERCLAIM OF ANY NATURE.  LB MAY DEFER PRODUCTION
OF FURTHER BATCHES IF TIMELY PAYMENT OF OUTSTANDING INVOICES IS NOT MADE WITHIN
THIRTY (30) DAYS OF A SECOND WRITTEN DEMAND (I.E., A WRITTEN DEMAND ISSUED AFTER
FAILURE TO SETTLE AN INVOICE WHICH INVOICE SHALL COUNT AS THE FIRST WRITTEN
DEMAND) FOR PAYMENT TO IMCLONE.  IF EITHER PARTY DISPUTES THE VALIDITY OF ANY
ITEM OR PART OF AN ITEM INCLUDED IN AN INVOICE, THE MATTER MAY BE REFERRED TO
THE STEERING COMMITTEE WHO SHALL RESOLVE SUCH DISPUTE AND MAY DETERMINE WHETHER
PENDING RESOLUTION AN EXTENSION OF TIME FOR PAYMENT OF SUCH DISPUTED ITEM IS
APPROPRIATE.

 

13.12.      INTEREST ON LATE PAYMENTS.  INTEREST ON LATE PAYMENTS OF INVOICES
AND OTHER AMOUNTS FROM TIME TO TIME OWED BY EITHER PARTY TO THE OTHER HEREUNDER
SHALL ACCRUE AT THE RATE OF

 

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TWO PERCENT (2%) ABOVE THE U.S. PRIME RATE FROM TIME TO TIME AS QUOTED IN THE
WALL STREET JOURNAL.

 

14.           WARRANTIES, COVENANTS, LIMITATION OF LIABILITY, ETC.

 

14.1.        LB REPRESENTATIONS, WARRANTIES AND COVENANTS.  LB REPRESENTS,
WARRANTS AND COVENANTS TO IMCLONE THAT:

 

14.1.1.     THE SERVICES SHALL BE PERFORMED IN ACCORDANCE WITH THIS AGREEMENT;

 

14.1.2.     THE PRODUCT DELIVERED TO IMCLONE PURSUANT TO SERVICES PERFORMED
UNDER THIS AGREEMENT SHALL MEET SPECIFICATIONS WHEN DELIVERED;

 

14.1.3.     UNENCUMBERED TITLE TO ALL PRODUCT WILL BE CONVEYED TO IMCLONE UPON
DELIVERY;

 

14.1.4.     LB HAS THE CORPORATE POWER AND AUTHORITY TO ENTER INTO THIS
AGREEMENT AND THAT LB WILL CAUSE LB (NH) TO HONOR THE TERMS OF THIS AGREEMENT
AND GUARANTEE THE PERFORMANCE OF LB (NH) UNDER THIS AGREEMENT;

 

14.1.5.     TO THE BEST OF LB’S KNOWLEDGE AND BELIEF, LB HAS THE RIGHT TO USE
THE STEPS OF 5000 LITER PROCESS MADE OR DEVELOPED BY LB AND HAS THE RIGHT TO USE
OR SUPPLY THE LB INFORMATION AND LB PATENT RIGHTS IN PERFORMANCE OF THE SERVICES
FOR IMCLONE AND THE USE BY LB OF SUCH 5000 LITER PROCESS STEPS MADE OR DEVELOPED
BY LB, LB INFORMATION AND LB PATENT RIGHTS WILL NOT INFRINGE ANY RIGHTS
(INCLUDING, WITHOUT LIMITATION, ANY INTELLECTUAL PROPERTY RIGHTS) OF ANY THIRD
PARTY;

 

14.1.6.     THE LB INFORMATION AND THE LB PATENT RIGHTS ARE OWNED BY LB OR LB IS
OTHERWISE ENTITLED TO USE THEM FOR THE PURPOSES OF PROVIDING SERVICES UNDER THIS
AGREEMENT AND DURING THE TERM OF THIS AGREEMENT LB SHALL NOT

 

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DO OR CAUSE ANYTHING TO BE DONE WHICH WOULD ADVERSELY AFFECT THEIR OWNERSHIP OR
ENTITLEMENT TO USE THE SAME FOR THOSE PURPOSES;

 

14.1.7.     LB WILL NOTIFY IMCLONE IN WRITING IMMEDIATELY IF IT KNOWS OR HAS
REASON TO BELIEVE THAT IT IS NO LONGER ENTITLED TO UTILIZE THE LB INFORMATION OR
THE LB PATENT RIGHTS OR THAT THE USE BY LB OF THE LB INFORMATION OR THE LB
PATENTS RIGHTS FOR SERVICES INFRINGES OR IS ALLEGED TO INFRINGE ANY RIGHTS
(INCLUDING WITHOUT LIMITATION, ANY INTELLECTUAL OR INDUSTRIAL PROPERTY RIGHTS)
VESTED IN ANY THIRD PARTY; AND

 

14.1.8.     LB HAS AND SHALL MAINTAIN, DURING THE TERM OF THIS AGREEMENT, ALL
GOVERNMENT PERMITS, INCLUDING BUT NOT LIMITED TO HEALTH, SAFETY AND
ENVIRONMENTAL PERMITS, NECESSARY FOR THE CONDUCT OF THE SERVICES.

 

14.1.9.   -TO LB’S KNOWLEDGE, LB HAS DISCLOSED, AND SHALL DISCLOSE, TO IMCLONE
ALL ENVIRONMENTAL REQUIREMENTS THAT LB IS AWARE OF OR BECOMES AWARE OF, WITHOUT
INDEPENDENT INVESTIGATION BY LB, WHICH IMCLONE MUST COMPLY WITH DURING THE USE
OF THE 5000 LITER PROCESS (EXCLUDING ANY STEPS MADE OR DEVELOPED BY IMCLONE).

 

14.1.10.   THE WARRANTIES CONTAINED IN THIS AGREEMENT ARE EXPRESSLY IN LIEU OF
AND EXCLUDE, AND LB HEREBY EXPRESSLY DISCLAIMS AND NEGATES, ALL OTHER
WARRANTIES, EXPRESS OR IMPLIED, ARISING BY OPERATION OF LAW OR OTHERWISE,
INCLUDING BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS

 

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FOR A PARTICULAR PURPOSE, EVEN IF THAT PURPOSE IS KNOWN TO LB.

 

14.2.        INDEMNIFICATION BY LB.  LB WILL INDEMNIFY, DEFEND AND HOLD HARMLESS
IMCLONE AND ITS AFFILIATES AGAINST ANY LOSS, DAMAGE, COSTS AND EXPENSES OF ANY
NATURE (INCLUDING REASONABLE FEES AND DISBURSEMENTS OF COUNSEL AND EXPERTS)
INCURRED BY IMCLONE OR ANY AFFILIATE OF IMCLONE OR ORDERED BY A COURT OF
COMPETENT JURISDICTION TO BE PAID OR PAYABLE BY IMCLONE OR ANY AFFILIATE OF
IMCLONE, TO THE EXTENT INCURRED AS THE RESULT OF (A) ANY BREACH OF THE
REPRESENTATIONS, WARRANTIES AND COVENANTS SET FORTH IN THIS AGREEMENT OR (B) ANY
CLAIMS (COLLECTIVELY, “IMCLONE CLAIMS”), ALLEGING THE USE OF LB PATENT RIGHTS,
OR THE LB INFORMATION INFRINGES OR IS ALLEGED TO INFRINGE ANY RIGHTS (INCLUDING
WITHOUT LIMITATION ANY INTELLECTUAL PROPERTY RIGHTS) OF A THIRD PARTY (WHETHER
OR NOT LB KNOWS OR OUGHT TO HAVE KNOWN OF SUCH INFRINGEMENT OR ALLEGED
INFRINGEMENT).  IT IS HEREBY AGREED THAT IMCLONE SHALL NOTIFY LB AS SOON AS IS
REASONABLY PRACTICABLE OF ANY CLAIM, ACTION OR PROCEEDINGS AND SHALL AT LB’S
COST PROVIDE LB WITH REASONABLE ASSISTANCE AND RELEVANT INFORMATION TO SUPPORT
LB TO AVOID, COMPROMISE OR DEFEND ANY SUCH CLAIM OR ACTION OR PROCEEDINGS. 
FURTHER, UNLESS THE SAME CONFLICT WITH OR PREJUDICE IMCLONE’S PROPER BUSINESS
INTERESTS OR MIGHT REASONABLY BE EXPECTED TO DO SO IMCLONE SHALL AT LB’S COST
TAKE SUCH ACTION AS LB MAY REASONABLY AND PROPERLY REQUIRE TO AVOID, COMPROMISE
OR DEFEND ANY SUCH CLAIM OR ACTION OR PROCEEDINGS.  NOTHING CONTAINED IN THIS
SECTION 14.2 SHALL OBLIGE IMCLONE TO TAKE ANY ACTION OR STEPS IN ITS OWN NAME IN
DEFENDING ANY CLAIM, ACTION OR PROCEEDINGS.  THE PROVISIONS OF THIS SECTION 14.2
SHALL BE IMCLONE’S SOLE AND EXCLUSIVE REMEDY, OTHER THAN CONTRACTUAL REMEDIES
EXPRESSLY SET FORTH HEREIN, IN CONNECTION WITH THE MATTERS DESCRIBED IN CLAUSES
(A) AND (B) ABOVE.

 

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14.3.        INDEMNIFICATION BY IMCLONE.  IMCLONE SHALL INDEMNIFY, DEFEND AND
HOLD LB AND ITS AFFILIATES HARMLESS AGAINST ALL CLAIMS, ACTIONS, COSTS, EXPENSES
(INCLUDING REASONABLE LEGAL FEES AND DISBURSEMENTS) OR OTHER LIABILITIES
WHATSOEVER OF THIRD PARTIES TO THE EXTENT INCURRED AS A DIRECT RESULT OF:

 

14.3.1.     ANY PRODUCT LIABILITY IN RESPECT OF THE PRODUCT, UNLESS SUCH
LIABILITY IS CAUSED BY THE NEGLIGENT ACT OR OMISSION OR WILLFUL MISCONDUCT OF LB
IN THE PRODUCTION AND/OR SUPPLY OF PRODUCT AND THE PRODUCT DEFECT RESULTING FROM
LB’S NEGLIGENT ACT OR OMISSION WAS NOT DETECTED BY THE IMCLONE TESTS; AND

 

14.3.2.     ANY NEGLIGENT OR WILLFUL ACT OR OMISSION OF IMCLONE IN RELATION TO
THE USE, PROCESSING, STORAGE OR SALE OF THE PRODUCT, THE APPLICATION OF THE
IMCLONE TESTS OR THE MARKETING OF THE PHARMACEUTICAL PRODUCT IN WHICH THE
PRODUCT IS USED.

 

14.4.        INSURANCE.  LB SHALL OBTAIN AND MAINTAIN INSURANCE COVERAGE OF THE
TYPES AND IN THE AMOUNTS CUSTOMARY AND CONSISTENT WITH INDUSTRY STANDARDS USED
IN THE CONTRACT BIOLOGICS MANUFACTURING INDUSTRY.  WITHOUT LIMITING THE
FOREGOING, LB SHALL OBTAIN AND MAINTAIN INSURANCE WHICH COVERS BUSINESS
INTERRUPTION.  LB AGREES THAT IT SHALL MAINTAIN PROFESSIONAL LIABILITY INSURANCE
IN AN AMOUNT NOT LESS THAN TEN MILLION DOLLARS (10,000,000) PER OCCURRENCE AND
AGGREGATE ON A CLAIMS MADE BASIS.  LB SHALL PROVIDE IMCLONE WITH EVIDENCE OF
SUCH INSURANCE UPON IMCLONE’S REQUEST AND SHALL PROVIDE IMCLONE WITH WRITTEN
NOTICE OF CANCELLATION OF SUCH INSURANCE POLICY, NOT LESS THAN TEN DAYS PRIOR TO
SUCH CANCELLATION.  IMCLONE SHALL OBTAIN AND MAINTAIN INSURANCE COVERAGE WHICH
IS CUSTOMARY AND CONSISTENT WITH BIOPHARMACEUTICAL INDUSTRY

 

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STANDARDS.  IMCLONE AGREES THAT IT SHALL MAINTAIN PRODUCT LIABILITY INSURANCE IN
AMOUNTS NOT LESS THAN TEN MILLION DOLLARS (10,000,000) PER OCCURRENCE AND
AGGREGATE ON A CLAIMS MADE BASIS.  IMCLONE SHALL PROVIDE LB WITH EVIDENCE OF
SUCH INSURANCE UPON LB’S REQUEST AND SHALL PROVIDE LB WITH WRITTEN NOTICE OF
CANCELLATION OF SUCH INSURANCE POLICY, NOT LESS THAN TEN DAYS PRIOR TO SUCH
CANCELLATION.

 

14.5.        RECALLS.

 

14.5.1.     IF IMCLONE, IN ITS DISCRETION, RECALLS THE PRODUCT (VOLUNTARILY OR
BY ORDER OF A REGULATORY BODY) OR IS REQUIRED TO RESPOND TO INQUIRIES OF
REGULATORY BODIES RELATING TO THE SERVICES HEREUNDER, LB AGREES TO PROVIDE
REASONABLE COOPERATION TO IMCLONE AT IMCLONE’S SOLE EXPENSE EXCEPT TO THE EXTENT
OF LB’S NEGLIGENCE OR WILLFUL MISCONDUCT.  ANY ASSISTANCE TO BE PROVIDED BY LB
IN RESPONSE TO INQUIRIES OF REGULATORY AUTHORITIES SHALL BE PROVIDED ON TERMS TO
BE AGREED AT LB’S STANDARD RATES FOR PROVIDING SUCH ASSISTANCE.

 

14.5.2.     SUBJECT TO THE LIMITATIONS OF LB’S LIABILITY TO IMCLONE SET OUT IN
THIS AGREEMENT, LB AGREES TO REIMBURSE IMCLONE FOR REASONABLE, DIRECT,
DOCUMENTED EXPENSES INCURRED BY IMCLONE AS A RESULT OF RECALL OF A PRODUCT
MANDATED BY LAW OR BY AN APPLICABLE REGULATORY BODY, BUT ONLY TO THE EXTENT LB’S
NEGLIGENCE OR WILLFUL MISCONDUCT IN PERFORMING THE SERVICES HAS CAUSED SUCH
RECALL TO BE REQUIRED AND SUCH RECALL COULD NOT HAVE REASONABLY HAVE BEEN
EXPECTED TO HAVE BEEN PREVENTED BY IMCLONE’S APPLICATION OF THE IMCLONE TESTS OR
OTHER PRODUCT TESTING REQUIRED BY LAW TO BE UNDERTAKEN BY IMCLONE.

 

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15.           LIMITATIONS OF LIABILITY.

 

15.1.        LIMITATION OF LIABILITY.  THE LIABILITY OF LB TO IMCLONE FOR ANY
LOSS SUFFERED BY IMCLONE AS A DIRECT RESULT OF A BREACH OF THIS AGREEMENT OR OF
ANY OTHER LIABILITY ARISING OUT OF THIS AGREEMENT AND SERVICES PROVIDED
THEREUNDER SHALL BE LIMITED TO THE PAYMENT OF DAMAGES WHICH SHALL NOT EXCEED
$10,000,000 PER EVENT OR DIRECTLY CONNECTED SERIES OF EVENTS.  THIS LIMITATION
SHALL NOT APPLY IF AND TO THE EXTENT SUCH DAMAGES ARE CAUSED BY LB’S VIOLATION
OF ANY ENVIRONMENTAL REQUIREMENTS IN THE PERFORMANCE OF THE SERVICES (UNLESS
SUCH VIOLATION WAS CAUSED BY A MISREPRESENTATION OF IMCLONE), INFRINGEMENT BY LB
OF ANY INTELLECTUAL PROPERTY OF ANY THIRD PERSON UNLESS CAUSED BY A
MISREPRESENTATION OF IMCLONE HEREUNDER, ANY CLAIMS BY EMPLOYEES OF LB, WILLFUL
MISCONDUCT OR INTENTIONAL BREACH OF THIS AGREEMENT OR WILLFUL MISCONDUCT IN THE
PERFORMANCE OF THE SERVICES.

 

15.2.        DISCLAIMER OF CONSEQUENTIAL DAMAGES.  NEITHER IMCLONE NOR LB SHALL
BE LIABLE FOR THE FOLLOWING LOSSES OR DAMAGES HOWSOEVER CAUSED (EVEN IF
FORESEEABLE OR IN THE CONTEMPLATION OF LB OR IMCLONE):

 

15.2.1.     LOSS OF PROFITS, BUSINESS OR REVENUE OF ANY PERSON OR PARTY; OR

 

15.2.2.     SPECIAL, INDIRECT OR CONSEQUENTIAL LOSS OF ANY PERSON OR PARTY.

 

15.3.        SURVIVAL.  THE RIGHTS AND OBLIGATIONS OF IMCLONE AND LB UNDER THIS
ARTICLE 15 SHALL SURVIVE THE TERMINATION OF THIS AGREEMENT.

 

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16.           IMCLONE INFORMATION, LB INFORMATION AND PATENT RIGHTS.

 

16.1.        CONFIDENTIAL INFORMATION.  IMCLONE ACKNOWLEDGES THAT LB INFORMATION
AND LB ACKNOWLEDGES THAT IMCLONE INFORMATION, IMCLONE MATERIALS DELIVERED
PURSUANT TO THIS AGREEMENT ARE DELIVERED SUBJECT TO OBLIGATIONS OF
CONFIDENTIALITY.  EACH PARTY AGREES TO KEEP THE OTHER PARTY’S INFORMATION AND
MATERIALS SECRET AND CONFIDENTIAL, RESPECT THE OTHER’S PROPRIETARY RIGHTS
THEREIN AND NOT WITHOUT THE OTHER PARTY’S PRIOR WRITTEN CONSENT (I) DISCLOSE,
(II) USE OUTSIDE THE SCOPE OF THIS AGREEMENT OR THE SERVICES AGREEMENTS OR (III)
PERMIT THE LB INFORMATION, THE IMCLONE INFORMATION OR THE IMCLONE MATERIAL TO BE
DISCLOSED TO ANY THIRD PARTY OR USED OUTSIDE THE SCOPE OF THIS AGREEMENT, EXCEPT
AS EXPRESSLY PROVIDED HEREIN.

 

16.2.        DISCLOSURE TO AFFILIATES, EMPLOYEES, ETC.  IMCLONE AND LB SHALL
GRANT ACCESS TO CONFIDENTIAL LB INFORMATION OR CONFIDENTIAL IMCLONE INFORMATION
ONLY TO THOSE AFFILIATES, EMPLOYEES, AND CONSULTANTS WHO HAVE A CLEAR AND
DEMONSTRABLE NEED TO KNOW SAID INFORMATION FOR THE PERFORMANCE OF THIS AGREEMENT
AND NO OTHERS UNLESS PREVIOUSLY IDENTIFIED IN WRITING TO AND AGREED TO BY LB AND
IMCLONE; AND CONTRACTORS WHO ARE SUBJECT TO THE SAME OBLIGATIONS OF
CONFIDENTIALITY AS LB AND IMCLONE UNDER APPROPRIATE SECRECY AGREEMENTS.

 

16.3.        THIRD PARTIES.  LB AND IMCLONE EACH UNDERTAKE NOT TO DISCLOSE OR
PERMIT TO BE DISCLOSED TO ANY THIRD PARTY, OR OTHERWISE MAKE USE OF OR PERMIT TO
BE MADE USE OF, ANY TRADE SECRETS OR CONFIDENTIAL INFORMATION RELATING TO THE
TECHNOLOGY, BUSINESS AFFAIRS OR FINANCES OF THE OTHER, ANY AFFILIATE OF THE
OTHER, OR OF ANY SUPPLIERS, AGENTS, DISTRIBUTORS, LICENSEES OR OTHER CUSTOMERS
OF THE OTHER WHICH COME INTO ITS POSSESSION UNDER THIS AGREEMENT.

 

16.4.        EXCEPTIONS.  THE CONFIDENTIALITY OBLIGATIONS UNDER THIS ARTICLE 16
SHALL NOT EXTEND TO ANY INFORMATION WHICH:

 

16.4.1.     IS OR BECOMES GENERALLY AVAILABLE TO THE PUBLIC OTHERWISE THAN BY
REASON OF A BREACH BY THE RECEIVING PARTY OF THE PROVISIONS OF THIS ARTICLE 16;

 

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16.4.2.     IS KNOWN TO THE RECEIVING PARTY PRIOR TO ITS RECEIPT FROM THE
DISCLOSING PARTY FREE OF ANY CONFIDENTIALITY OBLIGATION TO ANY THIRD PARTY;

 

16.4.3.     IS SUBSEQUENTLY DISCLOSED TO THE RECEIVING PARTY WITHOUT BEING MADE
SUBJECT TO AN OBLIGATION OF CONFIDENCE BY A THIRD PARTY; OR

 

16.4.4.     THE RECEIVING PARTY CAN DEMONSTRATE BY COMPETENT EVIDENCE WAS
INDEPENDENTLY DISCOVERED BY THE RECEIVING PARTY OR ITS EMPLOYEES WITHOUT
REFERENCE TO ANY INFORMATION RECEIVED FROM THE OTHER PARTY HERETO.

 

Notwithstanding the foregoing, either LB or ImClone may disclose confidential
information to the extent such disclosure is required by applicable law, court
order, statutory, regulatory, stock exchange or similar legislative requirement,
provided that the party making such required disclosure notifies the other party
as soon as possible to enable the parties to obtain a protective order against
such disclosure.

 

16.5.        NO LICENSE.  EACH PARTY ACKNOWLEDGES THAT, EXCEPT AS EXPRESSLY
PROVIDED HEREIN OR PURSUANT TO A SEPARATE AGREEMENT BETWEEN THE PARTIES EXISTING
NOW OR ENTERED INTO IN THE FUTURE, SUCH PARTY SHALL NOT BY VIRTUE OF THIS
AGREEMENT AT ANY TIME HAVE ANY RIGHT, TITLE, LICENSE OR INTEREST IN OR TO THE LB
INFORMATION, LB PATENT RIGHTS, IMCLONE INFORMATION, IMCLONE MATERIAL, OR IMCLONE
PATENT RIGHTS AS THE CASE MAY BE, OR ANY OTHER INTELLECTUAL PROPERTY RIGHTS
RELATING TO THE 5000 LITER PROCESS WHICH ARE OWNED BY THE OTHER PARTY OR ITS
AFFILIATES OR TO WHICH THE OTHER PARTY OR ITS AFFILIATES IS OTHERWISE ENTITLED.

 

17.           TERMINATION.

 

17.1 IN THE EVENT THAT LB FAILS TO COMPLY WITH CGMP AND IS UNABLE TO CONTINUE TO
MANUFACTURE PRODUCT UNDER FDA REGULATIONS AND SHOULD LB BE UNABLE OR UNWILLING
TO RESOLVE THE NON-COMPLIANCE AND REGAIN A STATE OF COMPLIANCE WITHIN 90 DAYS OF
RECEIVING NOTICE FROM THE

 

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FDA OF SUCH NON-COMPLIANCE, OR THE PARTIES REASONABLY AGREE THAT LB WILL NOT BE
ABLE TO BECOME COMPLIANT, THEN IMCLONE MAY, AS ITS SOLE REMEDY, TERMINATE THIS
AGREEMENT. IN THE EVENT THAT SUCH NON-COMPLIANCE HAS NOT BEEN RESOLVED, FOR ANY
REASON, FOR 180 DAYS FROM RECEIVING NOTICE FROM THE FDA OF SUCH NON-COMPLIANCE,
THIS AGREEMENT SHALL TERMINATE AUTOMATICALLY, UNLESS IT IS MUTUALLY AGREED BY
BOTH PARTIES IN WRITING TO EXTEND THE AGREEMENT FOR AN ADDITIONAL SPECIFIED TIME
PERIOD.

 

17.2.        TERMINATION WITHOUT CAUSE.  IMCLONE SHALL BE ENTITLED TO TERMINATE
THIS AGREEMENT AT ANY TIME WITHOUT CAUSE WITH 30 DAYS NOTICE IN WRITING.  IF
IMCLONE TERMINATES THIS AGREEMENT PURSUANT TO THIS SECTION 17.1, THEN WITHIN 30
DAYS OF RECEIPT OF THE NOTICE IMCLONE SHALL PAY TO LB THE BALANCE DUE OF THE
BATCH PRICE(S) FOR ANY UNDELIVERED OR UNORDERED BATCHES REQUIRED TO MAKE UP THE
MINIMUM ORDER BY IMCLONE IN ACCORDANCE WITH SECTION 6.3.

 

17.3.        This Section left intentionally blank.

 

17.4.        Termination for Cause.  LB and ImClone may each terminate this
Agreement, as their sole remedy, with 30 days notice in writing to the other
upon the occurrence of any of the following events:

 

17.4.3.     IF THE OTHER MATERIALLY BREACHES THIS AGREEMENT, AND (IN THE CASE OF
A BREACH CAPABLE OF REMEDY) SUCH BREACH IS NOT REMEDIED WITHIN NINETY (90) DAYS
OF THE RECEIPT BY THE OTHER OF NOTICE IDENTIFYING THE BREACH AND REQUIRING ITS
REMEDY OR, IF SUCH BREACH IS INCAPABLE OF REMEDY WITHIN NINETY (90) DAYS, THE
OTHER PARTY FAILS TO COMMENCE ACTIONS WITHIN SUCH NINETY (90) DAYS TO REMEDY
SUCH BREACH PURSUANT TO A PLAN ACCEPTABLE TO THE COMPLAINING PARTY. IN THE EVENT
OF TERMINATION BY LB PURSUANT TO THIS

 

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SECTION 17.4.3, IMCLONE SHALL PAY LB THE TERMINATION FEE AS SET FORTH IN SECTION
17.1.; OR

 

17.4.4.     IF THE OTHER CEASES FOR ANY REASON TO CARRY ON BUSINESS, DISSOLVES,
LIQUIDATES, WINDS UP, OR FILES OR IS PETITIONED INTO BANKRUPTCY, LIQUIDATION,
REHABILITATION OR DISSOLUTION OR BECOMES INSOLVENT OR FAILS GENERALLY TO PAY ITS
DEBTS OR OBLIGATIONS OR A PETITION IS FILED SEEKING THE APPOINTMENT OF OR

 

17.5.        EFFECT OF TERMINATION GENERALLY.  UPON THE TERMINATION OF THE
AGREEMENT FOR WHATEVER REASON:

 

17.5.1.     LB SHALL PROMPTLY RETURN ALL IMCLONE INFORMATION TO IMCLONE (TO THE
EXTENT LEGAL OR REGULATORY REQUIREMENTS PERMIT) AND SHALL DISPOSE OF, OR RETURN
TO IMCLONE THE IMCLONE MATERIALS AND ANY MATERIALS DERIVED THEREFROM, AS
DIRECTED BY IMCLONE;

 

17.5.2.     IMCLONE SHALL PROMPTLY RETURN TO LB (TO THE EXTENT LEGAL AND
REGULATORY REQUIREMENTS PERMIT) ALL LB INFORMATION IT HAS RECEIVED FROM LB;

 

17.5.3.     SUBJECT TO ANY RIGHTS GRANTED TO IMCLONE OR LB AS A RESULT OF ANY
WRITTEN AGREEMENT BETWEEN THE PARTIES, IMCLONE SHALL NOT THEREAFTER USE OR
EXPLOIT THE LB PATENT RIGHTS OR THE LB INFORMATION IN ANY WAY WHATSOEVER AND LB
SHALL NOT THEREAFTER USE OR EXPLOIT THE IMCLONE PATENT RIGHTS, THE IMCLONE
INFORMATION OR THE IMCLONE MATERIALS IN ANY WAY WHATSOEVER.  NO LICENSES SHALL
ARISE OR BE DEEMED TO HAVE ARISEN HEREUNDER EITHER BY DEFAULT, ESTOPPEL OR
OTHERWISE EXCEPT AS EXPRESSLY SET FORTH HEREIN;

 

17.5.4.     LB MAY THEREAFTER USE OR EXPLOIT THE LB PATENT RIGHTS IN ANY WAY
WHATSOEVER WITHOUT RESTRICTION;

 

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17.5.5.     LB AND IMCLONE SHALL DO ALL SUCH ACTS AND THINGS AND SHALL SIGN AND
EXECUTE ALL SUCH DEEDS AND DOCUMENTS AS THE OTHER MAY REASONABLY REQUIRE TO
EVIDENCE COMPLIANCE WITH THIS SECTION 17.5.

 

17.7.        SURVIVAL.  THE END OF THE TERM OR PRIOR TERMINATION OF THIS
AGREEMENT FOR WHATEVER REASON SHALL NOT AFFECT THE ACCRUED RIGHTS OF EITHER LB
OR IMCLONE ARISING UNDER THIS AGREEMENT AND ALL PROVISIONS WHICH BY THEIR TERMS
SURVIVE THE END OF THE TERM OR PRIOR TERMINATION OF THIS AGREEMENT SHALL REMAIN
IN FULL FORCE AND EFFECT, INCLUDING WITHOUT LIMITATION SECTIONS 3.7,14, 15, 16,
17, 19 AND 20.

 

18.           FORCE MAJEURE.

 

18.1.        IF EITHER PARTY IS PREVENTED OR DELAYED IN THE PERFORMANCE OF ANY
OF ITS OBLIGATIONS UNDER THIS AGREEMENT BY AN EVENT OF FORCE MAJEURE (AS DEFINED
BELOW) AND SHALL GIVE WRITTEN NOTICE THEREOF TO THE OTHER, SPECIFYING THE
MATTERS CONSTITUTING AN EVENT OF FORCE MAJEURE AND THE PERIOD FOR WHICH IT IS
ESTIMATED THAT EVENT OF FORCE MAJEURE WILL CONTINUE, THAT PARTY SHALL BE EXCUSED
FROM THE PERFORMANCE OR THE PUNCTUAL PERFORMANCE OF SUCH OBLIGATIONS, AS THE
CASE MAY BE, FROM THE DATE OF SUCH NOTICE FOR SO LONG AS SUCH CAUSE OF
PREVENTION OR DELAY SHALL CONTINUE.

 

18.2.        FOR THE PURPOSES OF THIS AGREEMENT, AN “EVENT OF FORCE MAJEURE”
SHALL MEAN CAUSES BEYOND THE REASONABLE CONTROL OF EITHER PARTY OR ITS
AFFILIATES INCLUDING, WITHOUT LIMITATION, ACTS OF GOD (INCLUDING BUT NOT LIMITED
TO EARTHQUAKE), LAWS OR REGULATIONS OF ANY GOVERNMENT OR AGENCY THEREOF, WAR,
TERRORISM, CIVIL COMMOTION, DAMAGE TO OR DESTRUCTION OF PRODUCTION FACILITIES OR
MATERIALS, SCIENTIFIC OR TECHNICAL EVENTS, LOCUSTS, LABOR DISTURBANCES (WHETHER
OR NOT ANY SUCH LABOR DISTURBANCE IS WITHIN THE POWER OF THE AFFECTED PARTY TO
SETTLE), EPIDEMIC, AND FAILURE OF SUPPLIERS, PUBLIC UTILITIES OR COMMON
CARRIERS.

 

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19.           GOVERNING LAW, JURISDICTION AND ENFORCEABILITY.

 

19.1.        GOVERNING LAW.  THE CONSTRUCTION, VALIDITY, PERFORMANCE, AND
ENFORCEMENT OF THIS AGREEMENT SHALL BE GOVERNED BY THE LAWS OF STATE OF NEW
YORK, WITHOUT GIVING EFFECT TO THE PRINCIPLES OF CONFLICTS OF LAW THEREOF.

 

19.2.        DISPUTE RESOLUTION.  IN THE EVENT OF THE FAILURE ON THE PART OF ANY
REQUIRED REPRESENTATIVE OF THE PARTIES HERETO OR THE STEERING COMMITTEE TO
RESOLVE ANY MATTER REQUIRED BY THIS AGREEMENT TO BE AGREED, OR IN THE EVENT OF
ANY OTHER DISPUTE OR CLAIM ARISING BETWEEN THE PARTIES UNDER THIS AGREEMENT, THE
PARTIES SHALL ATTEMPT BY GOOD FAITH NEGOTIATIONS TO RESOLVE SUCH DISPUTE OR
CLAIM BETWEEN THEM BY REFERENCE TO THE PRESIDENTS, WHO SHALL NEGOTIATE IN GOOD
FAITH DURING A PERIOD OF NOT LESS THAN SIXTY (60) DAYS TO RESOLVE SUCH MATTER,
DISPUTE OR CLAIM.  IN THE EVENT THE PARTIES ARE UNABLE TO RESOLVE SUCH DISPUTE
OR CLAIM WITHIN THE REQUIRED TIME, THE DISPUTE SHALL BE SETTLED BY BINDING
ARBITRATION, IN ACCORDANCE WITH THE CENTER FOR PUBLIC RESOURCES RULES FOR
NON-ADMINISTERED ARBITRATION OF BUSINESS DISPUTES, BY THREE ARBITRATORS, NONE OF
WHOM SHALL BE APPOINTED BY PARTIES.  THE ARBITRATORS SHALL BE SELECTED FROM THE
CPR PANELS OF DISTINGUISHED NEUTRALS AND SHALL BE ATTORNEYS WITH AT LEAST
FIFTEEN (15) YEARS EXPERIENCE IN COMMERCIAL LAW.  THE ARBITRATION SHALL BE
GOVERNED BY THE UNITED STATES ARBITRATION ACT, 9 U.S.C. §§ 1-16, AND JUDGMENT
UPON THE AWARD RENDERED BY THE ARBITRATORS MAY BE ENTERED IN ANY COURT HAVING
JURISDICTION THEREOF.  THE PLACE OF ARBITRATION SHALL BE NEW YORK, NEW YORK.

 

19.3.        NO WAIVER.  NO FAILURE OR DELAY ON THE PART OF EITHER LB OR IMCLONE
TO EXERCISE OR ENFORCE ANY RIGHTS CONFERRED ON IT BY THE AGREEMENT SHALL BE
CONSTRUED OR OPERATE AS A WAIVER THEREOF NOR SHALL ANY SINGLE OR PARTIAL
EXERCISE OF ANY RIGHT, POWER OR PRIVILEGE OR FURTHER EXERCISE THEREOF OPERATE SO
AS TO BAR THE EXERCISE OR ENFORCEMENT THEREOF AT ANY TIME OR TIMES THEREAFTER.

 

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19.4.        SEVERABILITY.  THE ILLEGALITY OR INVALIDITY OF ANY PROVISION (OR
ANY PART THEREOF) OF THIS AGREEMENT SHALL NOT AFFECT THE LEGALITY, VALIDITY OR
ENFORCEABILITY OF THE REMAINDER OF ITS PROVISIONS OR THE OTHER PARTS OF SUCH
PROVISION, AS THE CASE MAY BE.

 

20.           MISCELLANEOUS.

 

20.1.        ASSIGNMENT.  NEITHER PARTY SHALL BE ENTITLED TO ASSIGN THIS
AGREEMENT WITHOUT THE PRIOR WRITTEN CONSENT OF THE OTHER, WHICH CONSENT SHALL
NOT BE UNREASONABLY WITHHELD OR DELAYED, EXCEPT THAT BOTH PARTIES SHALL BE
ENTITLED WITHOUT THE PRIOR WRITTEN CONSENT OF THE OTHER TO ASSIGN THIS AGREEMENT
TO AN AFFILIATE OR TO ANY JOINT VENTURE COMPANY OF WHICH THAT PARTY IS THE
BENEFICIAL OWNER OF MORE THAN FIFTY PER CENT (50%) OF THE ISSUED VOTING SHARE
CAPITAL THEREOF OR TO ANY COMPANY TO WHICH THAT PARTY MAY TRANSFER SUBSTANTIALLY
ALL OF ITS ASSETS PROVIDED THAT IMCLONE MAY ASSIGN THIS AGREEMENT TO BMS (OR ONE
OF ITS SUBSIDIARIES) OR ANY OTHER COMMERCIAL PARTNER OF IMCLONE FOR ANY SUCH
PRODUCT WITHOUT SUCH CONSENT.  ANY ASSIGNMENT NOT PERMITTED BY THIS SECTION 20.1
SHALL BE VOID AND OF NO EFFECT WHATSOEVER.

 

20.2.        PUBLICITY.  THE TEXT OF ANY PRESS RELEASE OR OTHER COMMUNICATION TO
BE PUBLISHED BY OR IN THE MEDIA CONCERNING THE SUBJECT MATTER OF THIS AGREEMENT
SHALL REQUIRE THE PRIOR WRITTEN APPROVAL OF LB AND IMCLONE.

 

20.3.        ENTIRE AGREEMENT.  THIS AGREEMENT EMBODIES THE ENTIRE AGREEMENT AND
UNDERSTANDING BETWEEN LB AND IMCLONE RELATING TO THE SUBJECT MATTER HEREOF AND
THERE ARE NO PROMISES, TERMS, CONDITIONS OR OBLIGATIONS, ORAL OR WRITTEN,
EXPRESSED ON IMPLIED, OTHER THAN THOSE CONTAINED IN THIS AGREEMENT.  THE TERMS
OF THIS AGREEMENT SUPERSEDE ALL PREVIOUS AGREEMENTS AND UNDERSTANDINGS BETWEEN
LB AND IMCLONE RELATING TO THE SERVICES.

 

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20.4.        INDEPENDENT CONTRACTOR.  EACH PARTY TO THIS AGREEMENT ACTS AS AN
INDEPENDENT CONTRACTOR AND NOTHING IN THIS AGREEMENT SHALL BE CONSTRUED TO
CREATE A RELATIONSHIP OF PARTNERSHIP, PRINCIPAL AND AGENT, OR JOINT VENTURE
BETWEEN THE PARTIES.

 

20.5.        NOTICES.  ANY NOTICE OR OTHER COMMUNICATION TO BE GIVEN UNDER THIS
AGREEMENT SHALL BE DELIVERED PERSONALLY OR SENT BY FIRST CLASS PRE-PAID
REGISTERED OR CERTIFIED MAIL, RETURN RECEIPT REQUESTED, NATIONALLY RECOGNIZED
COURIER SERVICE OR FACSIMILE TRANSMISSION ADDRESSED AS FOLLOWS:

 

If to ImClone, to:

 

ImClone Systems Incorporated
33 Chubb Way
Branchburg, NJ  08876
For the attention of: Legal Department.
Facsimile: (908) 704-2719

 

with a copy to:

 

ImClone Systems Incorporated
33 Chubb Way
Branchburg, NJ  08876

 

For the attention of:  S. Joseph Tarnowski, Ph.D.
Facsimile:  (908) 575-0503

 

If to LB, to:

 

Lonza Biologics plc
228 Bath Road
Slough
Berkshire SL1 4DX
England
For the attention of:  Company Secretary
Facsimile: (011) 44 1753 777001

 

with a copy to:

 

Lonza Biologics, Inc.
101 International Drive
Portsmouth, New Hampshire 03801-2833

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For the attention of: COO
Facsimile: 001 603 610-5052

 

or to such other address as either party hereto may hereafter notify the other
in accordance with the provisions of this Section 20.5.  All such notices or
other communications shall be deemed to have been delivered as follows:

 

20.5.1.     IF DELIVERED PERSONALLY, AT THE TIME OF SUCH DELIVERY;

 

20.5.2.     IF SENT BY REGISTERED OR CERTIFIED MAIL, FIVE (5) BUSINESS DAYS
(SATURDAYS, SUNDAYS AND PUBLIC HOLIDAYS EXCLUDED) AFTER MAILING;

 

20.5.3.     IF SENT BY FACSIMILE, UPON RECEIPT OF THE TRANSMISSION CONFIRMATION
SLIP SHOWING COMPLETION OF THE TRANSMISSION;

 

20.5.4.     IF SENT BY COURIER SERVICE, TWO (2) DAYS AFTER BEING DISPATCHED.

 

20.6.        HEADINGS.  THE HEADINGS IN THIS AGREEMENT ARE FOR CONVENIENCE OF
REFERENCE ONLY AND SHALL NOT CONSTITUTE PART OF THIS AGREEMENT.

 

20.7.        COUNTERPARTS.  THIS AGREEMENT MAY BE EXECUTED IN SEVERAL
COUNTERPARTS, EACH OF WHICH IS AN ORIGINAL BUT ALL OF WHICH SHALL CONSTITUTE ONE
INSTRUMENT.

 

20.8.        BINDING EFFECT.  THIS AGREEMENT SHALL BE BINDING UPON AND INURE TO
THE BENEFIT OF THE PARTIES HERETO AND THEIR RESPECTIVE SUCCESSORS AND PERMITTED
ASSIGNS.

 

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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by
their duly authorized representatives as of the date first above written.

 

 

 

LONZA BIOLOGICS PLC

 

 

 

 

 

 

 

 

By:

 

 

 

 

 

 

 

 

Name:

 

 

 

 

 

 

 

 

 

Title:

 

 

 

 

 

 

 

 

 

 

IMCLONE SYSTEMS INCORPORATED

 

 

 

 

 

 

 

 

By:

 

 

 

 

 

 

 

 

Name:

 

 

 

 

 

 

 

 

 

 Title:

 

 

 

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ATTACHMENT 1

 

Final Product Specifications

 

 

THE FINAL PRODCUT SPECIFICATIONS FOR EACH PRODUCT ARE TO BE AGREED BETWEEN
PARTIES PRIOR TO THE COMMENCEMENT OF GMP MANUFACTURE FOR EACH PRODUCT
MANUFACTURED.

 

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[*****] 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.

 

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ATTACHMENT 2

 

Tech Transfer

 

 

1. It is assumed that the Process to be transferred is fully developed by
ImClone and can be transferred directly to the 5000L suite. In the event that it
is determined that additional process development work is required to complete
scale-up to LB’s facility, all such work shall be agreed in writing between
Parties and shall be charged by LB at the rate of $ 175 per man hour.

 

2. It is agreed and understood that prior to commencing with the production of
any GMP Batches that at least one (1) GMP pilot Batch of each Product shall be
successfully completed at the 5,000L scale and that such pilot Batch shall
conform to all those Specifications that are to be agreed between Parties for
the subsequent GMP Batches.  Further, Parties shall agree that the yield of the
pilot Batch is within the yield targets defined in section 6.7. In the event
that the pilot Batch does not meet the yield estimates, Parties shall
investigate the reason and as necessary revise the yield estimate.

 

3. ImClone shall provide, as reasonably requested by LB, all manufacturing batch
records, technical support and such personnel of ImClone necessary to complete
the timely and efficient transfer of the Process to LB’s facility. 

 

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[*****] 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.

 

50

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