SUCH REGULATORY AUTHORITY HAS REQUIRED
SUCH CLINICAL TRIALS AND [**], AND THE AGREEMENT SHALL REMAIN IN FULL FORCE AND
EFFECT IN THE REST OF THE GSK TERRITORY. FOR THE AVOIDANCE OF DOUBT, A [**]
SHALL NOT BE DEEMED A FAILURE TO EXERCISE ITS COMMERCIALLY REASONABLE EFFORTS.
IN THE EVENT THAT [**] TO UNDERTAKE SUCH REQUIRED STUDY, AND SEPRACOR BELIEVES
THAT THE USE OF THE RESULTS OF ANY REQUIRED STUDY COULD BE OF MATERIAL BENEFIT
TO SEPRACOR IN THE SEPRACOR TERRITORY, FOR EXAMPLE, IF THE REQUIRED STUDY WERE
THE DEVELOPMENT OF A [**] OF THE PRODUCT, THE PARTIES [**].
5.4.
ADDITIONAL DEVELOPMENT ACTIVITIES OF GSK. IN ADDITION TO
THE STUDIES PERMITTED IN SECTIONS 4.3 AND 5.3, AND IN ACCORDANCE WITH THE THEN
APPLICABLE APPROVED DEVELOPMENT PLAN, GSK SHALL HAVE THE RIGHT, BUT NOT THE
OBLIGATION, TO UNDERTAKE, AT GSK'S SOLE
CONFIDENTIAL
EXPENSE, COMMERCIALIZATION STUDIES IN THE GSK TERRITORY IN SUPPORT OF GSK'S
COMMERCIALIZATION OF THE PRODUCT. GSK SHALL INFORM SEPRACOR PURSUANT TO
SECTION 5.6 OF ITS INTENTION TO PURSUE SUCH COMMERCIALIZATION STUDIES PRIOR TO
THEIR INITIATION.
5.5.
INVESTIGATOR SPONSORED CLINICAL STUDY. FOR THE AVOIDANCE OF
DOUBT, GSK SHALL BE FREE, AT GSK'S SOLE EXPENSE, TO PROVIDE FINANCIAL OR IN-KIND
SUPPORT TO CLINICAL STUDIES OF THE PRODUCT THAT ARE SPONSORED AND CONDUCTED BY A
THIRD PARTY AND UNDERTAKEN IN THE GSK TERRITORY ("INVESTIGATOR SPONSORED
CLINICAL STUDIES"). GSK SHALL INFORM SEPRACOR PURSUANT TO SECTION 5.6 OF ITS
INTENTION TO PROVIDE FINANCIAL OR IN-KIND SUPPORT TO SUCH INVESTIGATOR SPONSORED
CLINICAL STUDIES PRIOR TO PROVIDING SUCH SUPPORT.
5.6.
DEVELOPMENT PLAN. IN THE EVENT THAT GSK PLANS DURING THE
TERM OF THIS AGREEMENT TO UNDERTAKE ANY REQUIRED STUDIES OR COMMERCIALIZATION
STUDIES, OR TO SUPPORT ANY INVESTIGATOR SPONSORED CLINICAL STUDIES IN THE GSK
TERRITORY, GSK SHALL GENERATE A DEVELOPMENT PLAN WHICH SHALL BE PRESENTED
PROMPTLY TO THE JSC FOR REVIEW TO ENSURE THAT THE DEVELOPMENT PLAN TAKES INTO
ACCOUNT AND IS CONSISTENT WITH THE GLOBAL BRANDING STRATEGY FOR THE PRODUCT. THE
DEVELOPMENT PLAN SHALL BE SUPPLEMENTED, MODIFIED AND UPDATED REGULARLY BY GSK AS
AND WHEN ADDITIONAL RELEVANT DATA AND INFORMATION BECOME AVAILABLE, BUT IN ANY
EVENT NOT LESS FREQUENTLY THAN ANNUALLY. REQUIRED STUDIES, COMMERCIALIZATION
STUDIES AND SUPPORT FOR INVESTIGATOR SPONSORED CLINICAL STUDIES SHALL NOT
COMMENCE UNTIL SUCH STUDIES HAVE BEEN PRESENTED TO THE JSC FOR REVIEW AND
WRITTEN NOTICE OF THE STUDIES SENT TO SEPRACOR. GSK SHALL KEEP THE JSC ADVISED
ON A TIMELY BASIS OF THE PROGRESS OF EACH SUCH STUDY.
5.7.
SEPRACOR'S REVIEW AND FINAL APPROVAL. NOTWITHSTANDING
ANYTHING TO THE CONTRARY CONTAINED IN THIS AGREEMENT, IN THE EVENT THAT SEPRACOR
IN GOOD FAITH BELIEVES THAT ANY DEVELOPMENT STUDIES GSK WISHES TO UNDERTAKE OR
SPONSOR PURSUANT TO SECTIONS 5.3 OR 5.4, OR ANY INVESTIGATOR SPONSORED CLINICAL
STUDIES GSK WISHES TO SUPPORT PURSUANT TO SECTION 5.5 HAS A [**], SEPRACOR
MAY PROVIDE WRITTEN NOTICE TO GSK WITHIN [**] OF SUCH STUDIES BEING PRESENTED TO
THE JSC, REQUESTING THAT GSK SHALL NOT PERFORM SUCH DEVELOPMENTAL STUDIES AND/OR
SHALL NOT SUPPORT SUCH INVESTIGATOR SPONSORED CLINICAL STUDIES.
(A)
IF