WITHHOLDING TAXES REQUIRED UNDER
APPLICABLE LAW TO BE PAID OR WITHHELD SHALL BE AN EXPENSE OF, AND BORNE SOLELY
BY, LICENSOR.
LICENSEE WILL PROVIDE LICENSOR WITH REASONABLE ASSISTANCE TO
ENABLE LICENSOR TO RECOVER SUCH TAXES AS PERMITTED BY LAW.
5.9
NO MULTIPLE ROYALTIES.
NO MULTIPLE
ROYALTIES UNDER SECTION 5.3 SHALL BE PAYABLE BECAUSE THE PRODUCT, ITS
MANUFACTURE, USE OR SALE IS OR SHALL BE COVERED BY MORE THAN ONE LICENSOR PATENT
RIGHT.
6.
PRODUCT DEVELOPMENT:
COLLABORATION
COMMITTEE
6.1
PRODUCT DEVELOPMENT OBLIGATIONS.
LICENSEE
SHALL HAVE CONTROL OVER DEVELOPMENT AND COMMERCIALIZATION IN THE TERRITORY OF
THE PRODUCT THROUGHOUT THE TERM.
LICENSEE (ITSELF OR THROUGH AN AFFILIATE OR
THIRD PARTY) WILL BE RESPONSIBLE FOR DETERMINING WHICH FORM(S) OF PRODUCTS TO
DEVELOP, THE DESIGN AND COMPLETION OF FORMULATION ACTIVITIES, AND PRE-CLINICAL
AND CLINICAL STUDIES IN THE TERRITORY.
LICENSEE WILL BEAR ALL THE EXPENSES FOR
PRODUCT DEVELOPMENT ACTIVITIES.
6.2
PRODUCT DEVELOPMENT DILIGENCE OBLIGATIONS.
6.2.1
LICENSEE, DURING THE TERM, AGREES TO USE DILIGENT
EFFORTS TO PROCEED WITH THE DEVELOPMENT, MANUFACTURE, AND
14
COMMERCIALIZATION OF PRODUCT(S) CONSISTENT WITH A FIRST COMMERCIAL SALE OF
PRODUCT ON OR BEFORE [*
*
*], EITHER BY ITSELF OR THROUGH AFFILIATE(S), THIRD
PARTIES, OR SUBLICENSEE(S).
SUBJECT TO THE OBLIGATIONS SET FORTH IN THE
IMMEDIATELY PRECEDING SENTENCE AND WITH RESPECT TO THE DEVELOPMENT OF PRODUCT,
THE PARTIES ACKNOWLEDGE THAT IT IS IN THEIR MUTUAL INTEREST TO CAUSE THE FIRST
COMMERCIAL SALE OF PRODUCT TO OCCUR ON OR BEFORE [*
*
*], AND THAT THE
DEVELOPMENT TARGET DATES SET FORTH IN EXHIBIT B REFLECT THE PARTIES' DESIRE TO
CAUSE THE FIRST COMMERCIAL SALE OF PRODUCT TO OCCUR BY THAT DATE, PROVIDED THAT
ALL OF THE ASSUMPTIONS SET FORTH IN EXHIBIT B PROVE TO BE CORRECT IN ALL
MATERIAL RESPECTS.
THE PARTIES ACKNOWLEDGE THAT THE DATES SET FORTH IN EXHIBIT
B ARE TARGET DATES, AND MAY NOT BE ACHIEVED FOR REASONS THAT INCLUDE WITHOUT
LIMITATION THE FOLLOWING:
(I) THE INACCURACY OF ANY OF THE ASSUMPTIONS SET
FORTH IN EXHIBIT B; (II) RECOMMENDATIONS OR REQUIREMENTS OF THE FDA RELATING TO
THE PRODUCT; (III) DELAYS IN THE DEVELOPMENT OF THE PRODUCT ARISING FROM ISSUES
RELATED TO INTELLECTUAL PROPERTY, SAFETY, CLINICAL TRIAL ENROLLMENT,
MANUFACTURING, OR SUPPLY.
SUBJECT TO THE QUALIFICATIONS SET FORTH IN THE
IMMEDIATELY PRECEDING SENTENCE, LICENSEE ADDITIONALLY AGREES TO USE DILIGENT
EFFORTS TO MEET THE PRODUCT DEVELOPMENT TARGET DATES SET FORTH IN EXHIBIT B.
6.2.2
THE PARTIES ACKNOWLEDGE AND AGREE THAT IN THE EVENT
THAT LICENSEE DETERMINES THAT ANY OF THE TARGET DATES SET FORTH IN EXHIBIT B IS
NOT REASONABLY ACHIEVABLE NOTWITHSTANDING LICENSEE'S COMPLIANCE WITH SECTION
6.2.1, AND THE FAILURE TO ACHIEVE SUCH TARGET DATE IS REASONABLY LIKELY TO
DELAY THE FIRST COMMERCIAL SALE OF THE PRODUCT BEYOND [*
*
*], THEN LICENSOR
AND LICENSEE SHALL MEET AND CONFER WITH UNIVERSITY REGARDING LICENSEE'S
DEVELOPMENT PROGRAM WITH RESPECT TO THE PRODUCT, AND REQUEST THAT LICENSOR'S
* * *
Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission.
15
OBLIGATION IN THE UNIVERSITY