SYSTEM AND
DESIGN CONTROL AGREEMENT, THE TERM CONTAINED IN THIS AGREEMENT SHALL PREVAIL.
6.13.
NON-COMPETE.
DURING THE TERM, COMPANY SHALL NOT DEVELOP, LICENSE,
MANUFACTURE, REGISTER, SELL, PROMOTE OR DISTRIBUTE IN THE TERRITORY, OR CAUSE OR
PERMIT TO BE DEVELOPED, LICENSED, MANUFACTURED, REGISTERED, SOLD, PROMOTED OR
DISTRIBUTED IN THE TERRITORY, WHETHER DIRECTLY OR INDIRECTLY, ANY COMPETITIVE
PRODUCT; PROVIDED HOWEVER, THAT, SUBJECT TO DISTRIBUTOR'S RIGHTS WITH RESPECT TO
THE OPTION PRODUCT SET FORTH IN SECTION 2.7(B), COMPANY SHALL HAVE THE RIGHT TO
MANUFACTURE, REGISTER, SELL, PROMOTE AND DISTRIBUTE THE OPTION PRODUCT IN THE
TERRITORY DURING THE TERM.
6.14.
PROOF OF CONCEPT STUDY.
COMPANY AGREES TO DILIGENTLY CONTINUE
CONDUCTING ITS ONGOING PROOF OF CONCEPT STUDY THAT COMPARES THE PRODUCT TO
ELIDEL® UNTIL COMPLETION, AT COMPANY'S SOLE COST AND EXPENSE AND SHALL PROVIDE
DISTRIBUTOR WITH THE RESULTS OF SUCH STUDY WITHIN A REASONABLE TIME AFTER THE
STUDY'S COMPLETION, BUT NO LATER THAN SIXTY (60) DAYS AFTER THE LAST PATIENT'S
VISIT, WITH A FINAL STUDY REPORT TO BE PROVIDED WITHIN ONE HUNDRED AND TWENTY
(120) DAYS OF THE LAST PATIENT'S VISIT.
6.15.
ADDITIONAL STUDIES.
AS MAY BE AGREED UPON BY THE PARTIES FROM TIME
TO TIME, THE COMPANY SHALL CONDUCT ADDITIONAL STUDIES DESIGNED TO SUPPORT THE
PRODUCT WITH FUNDING FOR SUCH ADDITIONAL STUDIES TO BE AGREED UPON BY THE
PARTIES.
6.16.
OTHER OBLIGATIONS OF COMPANY.
(A)
WITHIN [***] DAYS OF THE EFFECTIVE DATE, COMPANY AGREES TO
DEVELOP VALIDATED ANALYTICAL METHOD(S) TO CHARACTERIZE THE PRODUCT, FOR ITS
CHEMICAL COMPOSITION, AT ROOM AND ACCELERATED TEMPERATURE CONDITIONS
(B)
ONLY AT DISTRIBUTOR'S SPECIFIC REQUEST, AND IN THAT CASE WITHIN
[***] DAYS OR SUCH OTHER TIME FRAME AGREED UPON BY THE PARTIES, COMPANY AGREES
TO CONDUCT APPROPRIATE STUDIES COMPARING THE SAFETY AND EFFICACY OF THE CURRENT
PRODUCT FORMULATION AGAINST THE PRODUCT FORMULATION USED IN THE CLINICAL STUDY
COMPARING THE PRODUCT TO [***].
7.
OBLIGATIONS OF DISTRIBUTOR
7.1.
COMMERCIALIZATION OF THE PRODUCT.
DISTRIBUTOR SHALL USE
COMMERCIALLY REASONABLE EFFORTS, COMPARABLE TO THOSE A SIMILARLY SITUATED
COMPANY WOULD USE FOR A PRODUCT OF COMPARABLE COMMERCIAL OPPORTUNITY (WITHOUT
REFERENCE TO ANY COMPETITIVE PRODUCTS OF DISTRIBUTOR), TO (1) CAUSE THE LAUNCH
DATE OF THE PRODUCT TO OCCUR WITHIN [***] OF THE EFFECTIVE DATE; PROVIDED THAT
THE COMPANY CAN DELIVER LAUNCH QUANTITIES OF COMMERCIALLY VIABLE PRODUCT TO
DISTRIBUTOR WITHIN SUCH TIME PERIOD PURSUANT TO ORDERS PLACED BY DISTRIBUTOR;
AND (2) SELL AND DISTRIBUTE THE PRODUCT IN THE TERRITORY.
DISTRIBUTOR AGREES TO
[***] COMMENCING ON THE LAUNCH DATE FOR THE PRODUCT AND SHALL USE COMMERCIALLY
REASONABLE EFFORTS TO [***] DURING THE FIRST CONTRACT YEAR.
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7.2.
OTHER OBLIGATIONS OF THE DISTRIBUTOR.
DISTRIBUTOR AGREES:
(A)
TO ENSURE THAT THE TERRITORY IS COVERED BY ADEQUATE AND
REASONABLE SALES ACTIVITIES, COMPARABLE TO THOSE DISTRIBUTOR WOULD USE FOR A
PRODUCT OF COMPARABLE COMMERCIAL OPPORTUNITY, INCLUDING SAMPLING, ADVERTISING,
DISTRIBUTION OF TECHNICAL AND SALES MATTER, PRODUCT PERFORMANCE DEMONSTRATIONS
AND OTHER MEASURES FOR PROMOTING THE SALE OF PRODUCT, AND TO USE ITS
COMMERCIALLY REASONABLE EFFORTS, COMPARABLE TO THOSE DISTRIBUTOR WOULD USE FOR A
PRODUCT OF COMPARABLE COMMERCIAL OPPORTUNITY;
(B)
TO ENSURE THAT ANY