AND MATERIALS, INCLUDING ANY
PROPRIETARY KNOW-HOW AND ANY RESEARCH AND MASTER CELL BANKS, AND PROVIDE SUCH
TECHNICAL ASSISTANCE, AND (II) PROVIDE ANY RIGHTS AND LICENCES, INCLUDING ANY
RIGHTS OF REFERENCE TO ANY REGULATORY APPROVALS AND LICENCES TO ANY PATENT
RIGHTS CONTROLLED BY THE MANUFACTURER, IN EACH CASE ((I) AND (II)) TO ANY
SUBSTITUTE AND BACK-UP MANUFACTURERS DESIGNATED BY THE JMT OR, IN THE CASE OF A
BREACH OF A MANUFACTURING AGREEMENT BY A PARTY MANUFACTURER, THE OTHER PARTY, AS
[***]
59
[Confidential Treatment Required] for such substitute or back-up Manufacturer to
Manufacture the applicable Antibody Products.
(B)
EACH PARTY SHALL HAVE A LICENCE AND RIGHT TO
USE AND REFERENCE ANY MANUFACTURING-RELATED INFORMATION, INVENTIONS OR MATERIALS
CHARACTERISED, CONCEIVED, DEVELOPED, DERIVED, DISCOVERED, GENERATED, IDENTIFIED
OR OTHERWISE MADE BY ANY EMPLOYEE, CONSULTANT OR AGENT OF THE MANUFACTURER IN
CONNECTION WITH ANY MANUFACTURING ACTIVITIES CONDUCTED UNDER A MANUFACTURING
AGREEMENT OR THE EXISTING SUPPLY AGREEMENTS LISTED IN SCHEDULE 4 (MANUFACTURING
KNOW HOW) AND ANY PATENT RIGHTS WITH RESPECT THERETO (MANUFACTURING PATENTS) TO
DEVELOP, COMMERCIALISE, MANUFACTURE, MAKE, HAVE MADE, USE, SELL, HAVE SOLD,
OFFER TO SELL OR RESELL, IMPORT, EXPORT, DISTRIBUTE OR OTHERWISE TRANSFER
PHYSICAL POSSESSION OF OR OTHERWISE TRANSFER TITLE IN OR TO ANTIBODY PRODUCTS.
(C)
THE MANUFACTURER SHALL BE REQUIRED TO
OBTAIN AND MAINTAIN ALL REGULATORY APPROVALS RELATING TO THE MANUFACTURE OF
ANTIBODY PRODUCT AND GRANT ACCESS AND RIGHTS OF REFERENCE TO ALL SUCH REGULATORY
APPROVALS AND DRUG MASTER FILES AND OTHER DATA AS SET FORTH IN ARTICLE 7.5.
(D)
THE MANUFACTURER SHALL MANUFACTURE ANTIBODY
PRODUCTS IN FACILITIES DESCRIBED IN THE APPLICABLE REGULATORY APPROVALS IN
ACCORDANCE WITH (I) THE ANTIBODY PRODUCT SPECIFICATIONS, (II) GMP AND ALL OTHER
APPLICABLE LAW, AND (III) THE TERMS OF THE APPLICABLE MANUFACTURING AGREEMENT
((I)-(III) COLLECTIVELY, THE ANTIBODY PRODUCT STANDARDS).
(E)
THE TERMS OF THE MANUFACTURING AGREEMENT
SHALL BE CONSISTENT WITH AND PROVIDE FOR THE MANUFACTURE OF ANTIBODY PRODUCTS AS
REQUIRED AND ANTICIPATED BY THIS AGREEMENT.
(F)
THE MANUFACTURER SHALL NOT MANUFACTURE
FOR, OR SELL, LICENCE, OR DISTRIBUTE ANTIBODY PRODUCTS TO, ANY PERSON OR ENTITY
OTHER THAN THE PARTIES, THEIR AFFILIATES OR, IF IT HAS RECEIVED THE RELEVANT
PARTY'S CONSENT, A PARTY'S PERMITTED SUBLICENSEES OR DISTRIBUTORS.
(G)
THE MANUFACTURING AGREEMENT SHALL INCLUDE A
FORECASTING AND ORDER MECHANISM CONSISTENT WITH THE PROCEDURES ADOPTED BY THE
JDT, JCT AND JMT PURSUANT TO ARTICLES 4.6(B)(VIII), 6.5(A)(II) AND 7.2(A) THAT
IS DESIGNED TO ENSURE THAT THE MANUFACTURER IS ABLE TO MEET THE PARTIES'
CLINICAL AND COMMERCIAL REQUIREMENTS ON A TIMELY BASIS, WHICH SHALL PROVIDE
ADEQUATE FLEXIBILITY TO MEET UNEXPECTED DEMAND, OR THE LACK THEREOF,
PARTICULARLY AROUND LAUNCH.
(H)
MANUFACTURER SHALL GUARANTEE, AT THE TIME OF
DELIVERY, THAT ANTIBODY PRODUCTS SUPPLIED BY IT (I) HAVE BEEN MANUFACTURED,
PACKAGED, HELD AND SHIPPED IN ACCORDANCE WITH THE ANTIBODY PRODUCT STANDARDS AND
ALL OTHER APPLICABLE LAW; (II) ARE NOT ADULTERATED OR MISBRANDED UNDER THE
FFDCA, OR UNDER ANY OTHER APPLICABLE LAW; (III) MAY BE INTRODUCED INTO
INTERSTATE COMMERCE PURSUANT TO THE FFDCA; AND (IV) THAT THE PROCESSES,
PROCEDURES AND MATERIALS USED IN THE MANUFACTURE OF SUCH ANTIBODY