[***] [CONFIDENTIAL TREATMENT REQUIRED] TO
ENSURE THAT ANY DRAFT MANUFACTURING AGREEMENT SUBMITTED TO THE JMT FOR APPROVAL
COMPLIES WITH ARTICLE 7.8 AND DRAW TO THE JMT'S ATTENTION ANY ASPECT OF ANY
DRAFT MANUFACTURING AGREEMENT THAT DOES NOT COMPLY WITH ARTICLE 7.8;
(VIII)
SUPERVISE THE PERFORMANCE OF ANY THIRD PARTY
MANUFACTURER AND REPORT ANY BREACHES OF THE MANUFACTURING AGREEMENT TO THE JMT;
(IX)
PROVIDE ANY ADMINISTRATIVE ASSISTANCE
REQUIRED BY THE JMT IN CONNECTION WITH THE PERFORMANCE OF THE MANUFACTURING
AGREEMENT, INCLUDING COMPILATION OF FORECASTS AND SUBMISSION OF ORDERS;
(X)
TAKE SUCH ACTION AS THE JMT DIRECTS TO
ENFORCE THE PARTIES' RIGHTS, FOR THE BENEFIT OF BOTH PARTIES, AGAINST THIRD
PARTY MANUFACTURERS.
COSTS AND RECOVERIES OF ANY SUCH ENFORCEMENT ACTION BY THE
MANUFACTURING COORDINATOR SHALL BE TREATED IN ACCORDANCE WITH ARTICLE 7.9;
(XI)
HAVE THE RESPONSIBILITIES SET OUT IN ARTICLE
7.5(B); AND
56
(XII)
PROVIDE SUCH OTHER ASSISTANCE AS THE JMT MAY
REASONABLY REQUEST.
(B)
THE MANUFACTURING COORDINATOR SHALL ENSURE
THAT THE MANUFACTURE OF ANTIBODY PRODUCTS DOES NOT DEVIATE FROM THE AGREED
MANUFACTURING PLAN IN ANY MATERIAL RESPECT, UNLESS IT HAS OBTAINED THE JMT'S
PRIOR WRITTEN CONSENT TO SUCH MATERIAL DEVIATION [***] [CONFIDENTIAL TREATMENT
REQUIRED]; PROVIDED, HOWEVER THAT, WHERE TIME DOES NOT PERMIT, THE MANUFACTURING
COORDINATOR MAY DEVIATE FROM THE AGREED MANUFACTURING PLAN WITH THE PRIOR
WRITTEN CONSENT OF THE OTHER PARTY'S MANUFACTURING TEAM LEADER [***]
[CONFIDENTIAL TREATMENT REQUIRED]. WHERE THE PARTY THAT IS NOT THE MANUFACTURING
COORDINATOR'S MANUFACTURING TEAM LEADER CONSENTS TO A DEVIATION FROM THE AGREED
MANUFACTURING PLAN IN ACCORDANCE WITH THIS ARTICLE 7.4(B), THE MANUFACTURING
COORDINATOR SHALL PROMPTLY BRIEF THE JMT ON THE REASONS FOR THE DEVIATION AND ON
THE COURSE OF ACTION PURSUED.
(C)
THE MANUFACTURING COORDINATOR SHALL HAVE
THE RESPONSIBILITIES SET OUT OR REFERRED TO IN THIS ARTICLE 7.4 BUT SHALL NOT BE
RESPONSIBLE FOR ANY OTHER ACTIVITIES UNLESS ASSIGNED TO IT BY THE JMT AND SHALL
PROVIDE THE JMT WITH DETAILED REPORTS OF ITS ACTIVITIES MONTHLY WITHIN [***]
[CONFIDENTIAL TREATMENT REQUIRED] OF THE END OF THE RELEVANT CALENDAR MONTH OR
AT SUCH INTERVALS AS THE JMT MAY AGREE.
7.5
REGULATORY APPROVALS
(A)
WITHOUT PREJUDICE TO ARTICLE 5, IF A PARTY
IS THE MANUFACTURER, SUCH PARTY SHALL BE RESPONSIBLE FOR OBTAINING ALL NECESSARY
REGULATORY APPROVALS TO PERFORM ITS OBLIGATIONS UNDER THIS ARTICLE 7 AND THE
MANUFACTURING AGREEMENT AND SHALL (I) PROVIDE THE OTHER 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 THAT
ARE OTHERWISE NECESSARY 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 (II) GRANT TO THE OTHER PARTY A RIGHT OF ACCESS AND
REFERENCE TO ALL REGULATORY APPROVALS OR OTHER GOVERNMENT LICENCES,