ALIGNMENT ON THE STRATEGY
AND THE PLANS TO COMPLETE THE ACTIVITY CONSISTENT WITH THE INTEGRATED STRATEGY
AS DEFINED IN THE ANNUAL COLLABORATION PLANS.
5.14.
COMPLIANCE WITH LAWS.
EACH PARTY AGREES TO USE COMMERCIALLY
REASONABLE EFFORTS TO CARRY OUT ALL WORK ASSIGNED TO SUCH PARTY IN THE ANNUAL
COLLABORATION PLANS AND ITS OTHER OBLIGATIONS UNDER THIS AGREEMENT IN MATERIAL
COMPLIANCE WITH ALL APPLICABLE FEDERAL, NATIONAL, MULTINATIONAL, STATE,
PROVINCIAL OR LOCAL REGULATORY LAWS, REGULATIONS AND GUIDELINES GOVERNING THE
CONDUCT OF SUCH WORK, INCLUDING, WITHOUT LIMITATION, (A) THE FD&C ACT AND ANY
APPLICABLE IMPLEMENTING REGULATIONS, AND RELEVANT FOREIGN EQUIVALENTS THEREOF;
(B) CGMPS; (C) ALL OTHER APPLICABLE FDA GUIDELINES AND RELEVANT GUIDELINES OF
APPLICABLE REGULATORY AUTHORITIES; (D) ALL OTHER APPLICABLE LAWS AND
REGULATIONS, INCLUDING ALL APPLICABLE FEDERAL, NATIONAL, MULTINATIONAL, STATE,
PROVINCIAL AND LOCAL ENVIRONMENTAL, HEALTH AND SAFETY LAWS AND REGULATIONS IN
EFFECT AT THE TIME AND PLACE OF MANUFACTURE OF A PRODUCT; AND (E) ALL APPLICABLE
EXPORT AND IMPORT CONTROL LAWS AND REGULATIONS.
5.15.
LEGAL CLEARANCE.
SANDOZ SHALL HAVE SOLE RESPONSIBILITY TO MAKE
DECISIONS WITH RESPECT TO LEGAL CLEARANCE (EXCEPT WITH RESPECT TO THE
DETERMINATION OF WHETHER LEGAL CLEARANCE HAS OCCURRED, WHICH SHALL BE DETERMINED
IN ACCORDANCE WITH THE DEFINITIONS HEREIN OF FINAL ROW LEGAL CLEARANCE AND FINAL
U.S. LEGAL CLEARANCE, AS APPLICABLE); PROVIDED, THAT SUCH DECISIONS ARE
GENERALLY CONSISTENT WITH THE STRATEGY SET THEREFOR BY THE JOC.
SANDOZ SHALL
SELECT COUNSEL TO ASSIST WITH PATENT LITIGATION OCCURRING IN THE CONTEXT OF
LEGAL CLEARANCE, WHICH COUNSEL SHALL BE REASONABLY ACCEPTABLE TO MOMENTA.
6.
ADDITIONAL COMMERCIALIZATION PROVISIONS
6.1.
REVIEW AND OVERSIGHT.
OTHER THAN WITH RESPECT TO SECTION 6.2,
WHICH ACTIVITIES SHALL BE IN THE SOLE DISCRETION OF SANDOZ, BUT SUBJECT TO
SECTION 5.2, ALL RESPONSIBILITIES OF THE PARTIES WITH RESPECT TO
COMMERCIALIZATION OF THE PRODUCTS SHALL BE SUBJECT TO THE OVERSIGHT AND REVIEW
OF THE JSC AS SET FORTH IN ARTICLE 5.
NOTWITHSTANDING SECTIONS 1.89, 13.2, OR
ANY OTHER PROVISION OF THIS AGREEMENT (OTHER THAN SECTION 5.2), SANDOZ OR ITS
SUBLICENSEES SHALL HAVE THE RIGHT TO SET ALL OF THE PRICES FOR THE SALE OF
PRODUCTS TO THIRD PARTIES WHICH ARE THEIR IMMEDIATE CUSTOMERS IN THE RELEVANT
TERRITORIES; PROVIDED, THAT, WITH RESPECT TO THE COLLABORATION PRODUCTS, SUCH
PRICES ARE GENERALLY CONSISTENT WITH THE PRICING STRATEGY SET THEREFOR BY THE
JSC, ALTHOUGH THE PARTIES RECOGNIZE THAT SANDOZ SHALL HAVE THE FLEXIBILITY TO
CHANGE SUCH PRICES IN ORDER TO RESPOND TO SPECIFIC MARKET CONDITIONS, AND, WITH
RESPECT TO THE GLYCOPROTEIN PRODUCTS, THE JSC SHALL DISCUSS PRICING STRATEGY FOR
SUCH PRICES.
SANDOZ OR ITS SUBLICENSEES SHALL BE RESPONSIBLE FOR THE
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DISTRIBUTION AND SALE OF THE PRODUCTS AND FOR INVOICING AND BOOKING SALES OF THE
PRODUCTS IN THE RELEVANT TERRITORIES. THE NAME OF EACH COLLABORATION PRODUCT
SHALL BE THE GENERIC NAME OF THE COMPOUND IT CONTAINS UNLESS THE PARTIES
MUTUALLY AGREE THAT ITS NAME SHALL INCLUDE A TRADEMARK OR TRADENAME OR BE
PROTECTED AS A TRADEMARK (A "BRANDED COLLABORATION PRODUCT").
FOR EACH BRANDED
COLLABORATION PRODUCT, SANDOZ MAY NAME SUCH PRODUCT; PROVIDED, THAT SUCH NAME
SHALL NOT INCLUDE