EXCHANGE AGREEMENT.
SECTION 5.10
RECALLS, MARKET WITHDRAWALS OR CORRECTIVE ACTIONS.
IF ANY
REGULATORY AUTHORITY ISSUES OR REQUESTS A RECALL OR TAKES A SIMILAR ACTION IN
CONNECTION WITH LICENSED PRODUCT IN THE TERRITORY, OR IF EITHER PARTY DETERMINES
THAT AN EVENT, INCIDENT OR CIRCUMSTANCE HAS OCCURRED THAT MAY RESULT IN THE NEED
FOR A RECALL OR MARKET WITHDRAWAL IN THE TERRITORY, THE PARTY NOTIFIED OF SUCH
RECALL OR SIMILAR ACTION, OR THE PARTY THAT DESIRES SUCH RECALL, WITHDRAWAL OR
SIMILAR ACTION, SHALL, WITHIN []*, ADVISE THE OTHER PARTY THEREOF BY TELEPHONE
OR FACSIMILE.
CUBIST, IN CONSULTATION WITH ALNYLAM, SHALL DECIDE WHETHER TO
CONDUCT A RECALL OR PRODUCT WITHDRAWAL IN THE TERRITORY (EXCEPT IN THE CASE OF A
GOVERNMENT MANDATED RECALL, WHEN CUBIST MAY ACT WITHOUT SUCH ADVANCE NOTICE, BUT
SHALL NOTIFY ALNYLAM AS SOON AS POSSIBLE) AND THE MANNER IN WHICH ANY SUCH
RECALL OR WITHDRAWAL SHALL BE CONDUCTED.
ALNYLAM WILL MAKE AVAILABLE TO CUBIST,
UPON REQUEST, ALL OF ALNYLAM'S PERTINENT RECORDS THAT CUBIST MAY REASONABLY
REQUEST TO ASSIST CUBIST IN EFFECTING ANY RECALL.
SECTION 5.11
MEDICAL INQUIRIES.
CUBIST SHALL HANDLE ALL MEDICAL QUESTIONS OR
INQUIRIES FROM MEMBERS OF THE MEDICAL PROFESSION IN THE TERRITORY REGARDING
LICENSED PRODUCT IN THE FIELD. CUBIST'S REASONABLE COSTS ASSOCIATED WITH
HANDLING MEDICAL QUESTIONS OR INQUIRIES FROM MEMBERS OF THE MEDICAL PROFESSION
IN THE PROFIT-SHARE TERRITORY SHALL BE INCLUDED AS COMMERCIALIZATION COSTS IN
THE CALCULATION AND RECONCILIATION OF N.A. PRE-TAX PROFIT OR LOSS IN ACCORDANCE
WITH SECTION 7.4.
SECTION 5.12
EXPORT MONITORING.
CUBIST AND ITS RELATED PARTIES WILL USE
DILIGENT EFFORTS TO MONITOR AND PREVENT EXPORTS OF LICENSED PRODUCT FROM THE
TERRITORY TO COUNTRIES IN ASIA, USING METHODS COMMONLY USED IN THE INDUSTRY FOR
SUCH PURPOSE, AND SHALL PROMPTLY INFORM ALNYLAM OF ANY SUCH EXPORTS OF LICENSED
PRODUCT FROM THE TERRITORY TO COUNTRIES IN ASIA, AND THE ACTIONS TAKEN TO
PREVENT SUCH EXPORTS.
CUBIST AGREES TO TAKE ANY ACTIONS REASONABLY REQUESTED IN
WRITING BY ALNYLAM THAT ARE CONSISTENT WITH APPLICABLE LAW TO PREVENT EXPORTS OF
LICENSED PRODUCT FROM THE TERRITORY TO COUNTRIES IN ASIA.
ALNYLAM SHALL USE
DILIGENT EFFORTS TO EFFECT PROVISIONS WITH ITS ASIAN PARTNER THAT REQUIRE THE
ASIAN PARTNER TO USE EFFORTS CONSISTENT WITH THOSE REQUIRED OF CUBIST UNDER THIS
SECTION 5.12 TO INFORM CUBIST OF, AND TO PREVENT, EXPORTS OF LICENSED PRODUCTS
FROM COUNTRIES IN ASIA INTO COUNTRIES IN THE TERRITORY.
ARTICLE VI
MANUFACTURE AND SUPPLY
SECTION 6.1
SUPPLY OBLIGATIONS; ALNYLAM'S EXISTING MANUFACTURING ARRANGEMENTS.
(A)
SUBJECT TO SECTION 6.2, FROM AND AFTER THE EFFECTIVE DATE, ALNYLAM
WILL USE DILIGENT EFFORTS, EITHER ITSELF OR THROUGH THIRD PARTIES, TO
MANUFACTURE, IN ACCORDANCE WITH APPLICABLE CGMP (AS DEFINED IN THE SUPPLY
AGREEMENT TERM SHEET), AND SUPPLY TO CUBIST API BULK DRUG SUBSTANCE AND FINISHED
PRODUCT (AS APPLICABLE) IN QUANTITIES THAT ARE REASONABLY SUFFICIENT FOR THE
CONDUCT OF DEVELOPMENT AND COMMERCIALIZATION BY CUBIST WITH RESPECT TO THE
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
46
PROFIT-SHARE
TERRITORY UNDER THE DEVELOPMENT PLAN AND COMMERCIALIZATION PLAN,
RESPECTIVELY, AND FOR DEVELOPMENT AND COMMERCIALIZATION IN THE