APPROVALS OR
CERTIFICATES RELATING TO THE MANUFACTURE OF AN ANTIBODY PRODUCT AND ANY DRUG
MASTER FILE RELATING TO AN ANTIBODY PRODUCT.
(B)
WITHOUT PREJUDICE TO ARTICLE 5, IF A THIRD
PARTY IS THE MANUFACTURER, THE MANUFACTURING COORDINATOR SHALL BE RESPONSIBLE
FOR ENSURING THAT THE MANUFACTURER:
(I)
OBTAINS ALL NECESSARY REGULATORY
APPROVALS TO PERFORM ITS OBLIGATIONS UNDER THE MANUFACTURING AGREEMENT OR ANY OF
THE AGREEMENTS LISTED IN SCHEDULE 4;
(II)
PROVIDES EACH PARTY WITH ALL CHEMISTRY,
MANUFACTURING AND CONTROLS DATA AND SUCH OTHER DATA AND INFORMATION WITH RESPECT
TO THE MANUFACTURE, HOLDING, SHIPMENT AND TESTING OF SUCH ANTIBODY PRODUCT (OR A
DRUG MASTER FILE OR EQUIVALENT OUTSIDE THE UNITED STATES CONTAINING THE SAME) AS
ARE REQUIRED BY CGMP AND OTHER APPLICABLE LAW OR ARE OTHERWISE NECESSARY
57
for each Territorial Lead to obtain and maintain all INDs, Drug Approval
Applications and Regulatory Approvals for the sale and use of such Antibody
Product in each country in respect of which it is the Territorial Lead; and
(III)
GRANTS TO EACH PARTY A RIGHT OF ACCESS AND
REFERENCE TO ALL REGULATORY APPROVALS OR OTHER GOVERNMENT LICENCES, APPROVALS OR
CERTIFICATES RELATING TO THE MANUFACTURE OF AN ANTIBODY PRODUCT AND ANY DRUG
MASTER FILE RELATING TO AN ANTIBODY PRODUCT.
7.6
TRANSFER PRICE
The Transfer Price for Antibody Product shall be calculated as defined in
Schedule 2.
7.7
MANUFACTURING
(A)
THE PARTIES AGREE THAT CLINICAL SUPPLIES OF
CDP-791 REQUIRED FOR DEVELOPMENT THROUGH [***] [CONFIDENTIAL TREATMENT
REQUIRED].
IF AT ANY TIME UCB BECOMES AWARE THAT THESE[***] [CONFIDENTIAL
TREATMENT REQUIRED] WILL NOT BE SUFFICIENT TO MEET SUCH DEVELOPMENT SUPPLY
NEEDS, IT SHALL PROMPTLY NOTIFY THE JMT.
FOR THE AVOIDANCE OF DOUBT, THE
PARTIES EXPRESSLY ACKNOWLEDGE THAT THESE [***] [CONFIDENTIAL TREATMENT
REQUIRED].
(B)
UNLESS OTHERWISE AGREED BY THE PARTIES, ANY
MANUFACTURING AGREEMENT (WITH A PARTY OR A THIRD PARTY), SHALL INCLUDE THE TERMS
SET OUT IN ARTICLE 7.8 AND SUCH OTHER TERMS AS THE JMT CONSIDERS NECESSARY OR
APPROPRIATE IN THE CIRCUMSTANCES.
(C)
IF THE JMT SELECTS A THIRD PARTY TO BE THE
MANUFACTURER OF ANTIBODY PRODUCT, THAT THIRD PARTY AND BOTH IMCLONE AND UCB
SHALL BE PARTIES TO THE MANUFACTURING AGREEMENT UNLESS THAT WOULD BE
IMPRACTICABLE OR UCB OR IMCLONE, AS THE CASE MAY BE, ELECTS NOT TO BE A PARTY.
(D)
EACH PARTY SHALL COMPLY AND OPERATE IN
ACCORDANCE WITH THE TERMS OF ANY MANUFACTURING AGREEMENT AND [***] [CONFIDENTIAL
TREATMENT REQUIRED] TO WHICH IT IS A PARTY IF AND TO THE EXTENT THAT SUCH
AGREEMENTS RELATE TO THE SUPPLY OF ANTIBODY PRODUCT UP TO AND INCLUDING [***]
[CONFIDENTIAL TREATMENT REQUIRED]; PROVIDED, HOWEVER, THAT NOTHING SHALL REQUIRE
EITHER PARTY TO TAKE ANY ACTION IN VIOLATION OF APPLICABLE LAW OR REFRAIN FROM
TAKING ANY ACTION IF TO DO SO WOULD PUT IT IN VIOLATION OF APPLICABLE LAW.
(E)
WITHOUT PREJUDICE TO UCB'S OBLIGATIONS
PURSUANT TO ARTICLE 4.1(A), UCB SHALL AS SOON AS PRACTICABLE FOLLOWING THE
EFFECTIVE DATE AND IN ANY EVENT WITHIN [***] [CONFIDENTIAL TREATMENT REQUIRED]
FOLLOWING THE EFFECTIVE DATE, TRANSFER IN AGGREGATE [***] [CONFIDENTIAL
TREATMENT REQUIRED] OF