TO BE OBTAINED BY IT AS OF THE EFFECTIVE DATE IN
CONNECTION WITH THE EXECUTION, DELIVERY AND PERFORMANCE OF THIS AGREEMENT HAVE
BEEN OBTAINED BY THE EFFECTIVE DATE.
SECTION 10.4
NO CONFLICT.
ALNYLAM AND CUBIST EACH REPRESENTS AND WARRANTS TO
THE OTHER PARTY THAT, NOTWITHSTANDING ANYTHING TO THE CONTRARY IN THIS
AGREEMENT, THE EXECUTION AND DELIVERY OF THIS AGREEMENT BY SUCH PARTY, THE
PERFORMANCE OF SUCH PARTY'S OBLIGATIONS HEREUNDER AND THE LICENSES AND
SUBLICENSES TO BE GRANTED BY SUCH PARTY PURSUANT TO THIS AGREEMENT (A) DO NOT
CONFLICT WITH OR VIOLATE ANY REQUIREMENT OF APPLICABLE LAWS EXISTING AS OF THE
EFFECTIVE DATE AND APPLICABLE TO SUCH PARTY AND (B) DO NOT CONFLICT WITH,
VIOLATE, BREACH OR CONSTITUTE A DEFAULT UNDER ANY CONTRACTUAL OBLIGATIONS OF
SUCH PARTY OR ANY OF ITS AFFILIATES EXISTING AS OF THE EFFECTIVE DATE.
EACH
PARTY SHALL COMPLY WITH ALL LAWS APPLICABLE TO THE DEVELOPMENT, MANUFACTURE AND
COMMERCIALIZATION OF THE PRODUCT, INCLUDING APPLICABLE DRUG REGULATION LAWS,
CLINICAL INVESTIGATION LAWS AND HEALTH CARE LAWS.
SECTION 10.5
ENFORCEABILITY.
ALNYLAM AND CUBIST EACH REPRESENTS AND WARRANTS
TO THE OTHER PARTY THAT, AS OF THE EFFECTIVE DATE, THIS AGREEMENT IS A LEGAL AND
VALID OBLIGATION BINDING UPON IT AND IS ENFORCEABLE AGAINST IT IN ACCORDANCE
WITH ITS TERMS.
SECTION 10.6
SALES REPRESENTATIVES.
(A)
CUBIST REPRESENTS AND WARRANTS TO ALNYLAM
THAT IT WILL USE DILIGENT EFFORTS TO CAUSE ITS SALES REPRESENTATIVES IN THE
TERRITORY NOT TO MAKE STATEMENTS, CLAIMS OR UNDERTAKINGS TO ANY PERSON WITH WHOM
THEY DISCUSS OR PROMOTE LICENSED PRODUCT THAT ARE NOT CONSISTENT WITH, AND NOT
TO PROVIDE OR USE ANY LABELING, LITERATURE, OR OTHER MATERIALS OTHER THAN THOSE
CONSISTENT WITH, PROMOTIONAL MATERIALS PROVIDED TO THE JCT FOR REVIEW AND
COMMENT IN ADVANCE OF USE IN THE TERRITORY.
CUBIST SHALL NOT, AND SHALL USE
DILIGENT EFFORTS TO CAUSE ITS SALES REPRESENTATIVES NOT TO, MAKE ANY
REPRESENTATION, STATEMENT, WARRANTY OR GUARANTY WITH RESPECT TO LICENSED PRODUCT
THAT IS NOT CONSISTENT WITH THE APPLICABLE, CURRENT PACKAGE INSERT OF
PRESCRIBING INFORMATION OR OTHER DOCUMENTATION ACCOMPANYING OR DESCRIBING
LICENSED PRODUCT, INCLUDING CUBIST'S STANDARD LIMITED WARRANTY AND DISCLAIMERS,
IF ANY.
(B)
CUBIST REPRESENTS AND WARRANTS TO ALNYLAM
THAT IT SHALL USE DILIGENT EFFORTS TO CAUSE ITS SALES REPRESENTATIVES TO COMPLY
WITH THE APPLICABLE LAWS AND GUIDELINES AND RELATED TO THE PERFORMANCE OF ITS
OBLIGATIONS HEREUNDER, INCLUDING THE FEDERAL FOOD, DRUG AND COSMETICS ACT, THE
PRESCRIPTION DRUG MARKETING ACT OF 1987, THE FEDERAL AND STATE ANTI-KICKBACK
STATUTES AND ALL APPLICABLE REGULATIONS THEREUNDER, AND AMA GUIDELINES ON GIFTS
TO PHYSICIANS FROM INDUSTRY AND PHRMA GUIDELINES, AND ALL RELEVANT EMEA
REGULATIONS, AUTHORIZATIONS AND LOCAL LAWS REGARDING ADVERTISEMENT, SALE AND
PROMOTION OF PHARMACEUTICAL PRODUCTS AS WELL AS ANY
*Confidential Treatment Requested.
Omitted portions filed separately with the
Commission.
69
RELEVANT CODE OF PRACTICE, IN EACH CASE AS AMENDED FROM TIME TO TIME, AND TO
COMPLY WITH THE POLICIES IN CUBIST'S COMPLIANCE TRAINING MATERIALS FOR THE
TERRITORY.
SECTION 10.7
ADDITIONAL REPRESENTATIONS AND WARRANTIES OF ALNYLAM.
ALNYLAM
REPRESENTS AND WARRANTS TO CUBIST THAT, EXCEPT AS SET FORTH ON