OBLIGATIONS UNDER THE ALNYLAM IN-LICENSES.
CUBIST SHALL ALSO PROVIDE
TO THE JCT SUCH OTHER INFORMATION AS ALNYLAM MAY REASONABLY REQUEST RELATED TO
COMMERCIALIZATION OF LICENSED PRODUCT IN THE TERRITORY AND SHALL KEEP THE JCT
REASONABLY INFORMED OF CUBIST'S COMMERCIALIZATION ACTIVITIES WITH RESPECT TO
LICENSED PRODUCT IN THE FIELD IN THE TERRITORY.
(B)
ASIA.
ALNYLAM SHALL PREPARE AND DELIVER TO THE JCT (OR, IF THE
JCT DOES NOT EXIST, SHALL DELIVER TO CUBIST), BY NO LATER THAN EACH []* (FOR THE
PERIOD ENDING DECEMBER 31 OF THE PRIOR CALENDAR YEAR), WRITTEN REPORTS
SUMMARIZING THE COMMERCIALIZATION ACTIVITIES OF ALNYLAM AND ITS RELATED PARTIES
WITH RESPECT TO LICENSED PRODUCT IN THE FIELD FOR ASIA PERFORMED TO DATE (OR
UPDATING SUCH REPORT FOR ACTIVITIES PERFORMED SINCE THE LAST SUCH REPORT
SUBMITTED HEREUNDER, AS APPLICABLE).
IN ADDITION, ALNYLAM SHALL PROVIDE CUBIST
WITH WRITTEN NOTICE WITHIN []* AFTER ALNYLAM BECOMES AWARE (BUT IN ANY EVENT
PRIOR TO PUBLIC DISCLOSURE BY ALNYLAM) OF (I) ALL FILINGS AND SUBMISSIONS FOR
REGULATORY APPROVALS REGARDING LICENSED PRODUCT IN ASIA; AND (II) ALL REGULATORY
APPROVALS OBTAINED OR DENIED, THE FILING OF ANY IND FOR LICENSED PRODUCT OR THE
FIRST COMMERCIAL SALE OF LICENSED PRODUCT, IN EACH CASE IN EACH COUNTRY IN
ASIA.
ALNYLAM SHALL ALSO PROVIDE SUCH OTHER INFORMATION TO CUBIST AS CUBIST MAY
REASONABLY REQUEST AND SHALL KEEP CUBIST REASONABLY INFORMED OF
COMMERCIALIZATION ACTIVITIES OF ALNYLAM AND ITS ASIAN PARTNER WITH RESPECT TO
LICENSED PRODUCT IN THE FIELD IN ASIA.
SECTION 5.8
OTHER RESPONSIBILITIES.
WITHOUT INTENDING TO LIMIT IN ANY WAY
CUBIST'S OVERALL RESPONSIBILITY FOR COMMERCIALIZATION OF LICENSED PRODUCTS IN
THE TERRITORY, THE PARTIES AGREE THAT CUBIST SHALL BE SOLELY RESPONSIBLE FOR
(A) HANDLING ALL RETURNS OF LICENSED PRODUCT, IN THE TERRITORY, IT BEING
UNDERSTOOD THAT IF LICENSED PRODUCT IS RETURNED TO ALNYLAM, IT SHALL PROMPTLY BE
SHIPPED TO A FACILITY DESIGNATED BY CUBIST; AND (B) HANDLING ALL ASPECTS OF
LICENSED PRODUCT ORDER PROCESSING, INVOICING AND COLLECTION, DISTRIBUTION,
INVENTORY AND RECEIVABLES IN THE TERRITORY; PROVIDED THAT IN THE PROFIT-SHARE
TERRITORY, THE COSTS OF SUCH ACTIVITIES SHALL BE INCLUDED AS COMMERCIALIZATION
COSTS OR DISTRIBUTION COSTS, AS THE CASE MAY BE, IN THE CALCULATION AND
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
44
RECONCILIATION OF N.A. PRE-TAX PROFIT OR LOSS IN ACCORDANCE WITH SECTION 7.4.
ALL RETURNS WILL BE REQUIRED TO BE MADE IN ACCORDANCE WITH CUBIST'S STANDARD
RETURN PROCEDURES WHICH REQUIRE A RETURN AUTHORIZATION TO BE ISSUED BY CUBIST OR
ITS DESIGNEE.
SECTION 5.9
ADVERSE EVENT AND LICENSED PRODUCT COMPLAINT REPORTING PROCEDURES;
NOTICE OF INFORMATION AFFECTING MARKETABILITY OF LICENSED PRODUCT.
EACH PARTY
WILL MAINTAIN A RECORD OF ANY AND ALL COMPLAINTS IT RECEIVES WITH RESPECT TO
LICENSED PRODUCTS, AND WILL USE DILIGENT EFFORTS TO ENSURE THAT ITS RELATED
PARTIES MAINTAIN SUCH RECORDS.
EACH PARTY WILL NOTIFY THE OTHER PARTY IN
REASONABLE DETAIL OF ANY COMPLAINT IT RECEIVES WITH RESPECT TO LICENSED PRODUCT
WITHIN SUFFICIENT TIME TO ALLOW THE OTHER PARTY AND ITS RELATED PARTIES TO
COMPLY WITH ANY AND ALL REGULATORY AND OTHER REQUIREMENTS IMPOSED UPON