FORM OF THE MEETING.
EITHER PARTY MAY INVITE UP TO FIVE (5)
ADDITIONAL PARTICIPANTS TO ANY MEETING OF THE JMT.
EACH PARTY SHALL BEAR ITS
OWN TRAVEL AND RELATED COSTS INCURRED IN CONNECTION WITH PARTICIPATION IN THE
JMT AND THE JMT."
3
1.4
SECTION 9.10.
THE FOLLOWING SECTION 9.10 IS HEREBY ADDED TO THE
AGREEMENT:
"9.10
CLINICAL STUDIES.
NOTWITHSTANDING ANY PROVISION OF THIS AGREEMENT
TO THE CONTRARY, DEPOMED SHALL BE ENTITLED TO CONDUCT CLINICAL STUDIES OR TRIALS
UTILIZING THE LICENSED PRODUCT ("CLINICAL STUDIES") AT ITS SOLE EXPENSE (A) FOR
THE PURPOSE OF SUPPORTING REGULATORY APPROVAL OF ONE OR MORE ADDITIONAL
INDICATIONS FOR THE LICENSED PRODUCT, OR (B) THAT OTHERWISE COULD ENHANCE OR
SUPPORT THE MARKETING OF THE LICENSED PRODUCT.
THE JMT SHALL REVIEW AND APPROVE
THE DESIGN OF, AND ANY PROTOCOL RELATED TO AND THE DISSEMINATION OF, ANY
CLINICAL STUDY CONDUCTED BY OR ON BEHALF OF DEPOMED.
ESPRIT HEREBY GRANTS A
NON-EXCLUSIVE LICENSE UNDER THE PATENT RIGHTS SOLELY FOR THE PURPOSE OF
CONDUCTING, OR HAVING CONDUCTED, CLINICAL STUDIES.
ALL REGULATORY DATA
GENERATED IN ANY SUCH CLINICAL STUDY CONDUCTED BY OR ON BEHALF OF DEPOMED SHALL
BE OWNED BY DEPOMED. HOWEVER DEPOMED SHALL ALLOW ESPRIT, AT NO ADDITIONAL COST,
TO UTILIZE SUCH DATA IN CONNECTION WITH ITS PROMOTIONAL ACTIVITIES. DEPOMED
SHALL BE PERMITTED TO PUBLISH THE RESULTS OF ANY SUCH CLINICAL STUDY CONDUCTED
BY OR ON BEHALF OF DEPOMED, AFTER AFFORDING ESPRIT AT LEAST TWENTY (20) DAYS TO
REVIEW AND COMMENT ON ANY SUCH PUBLICATION, AND CONSIDERING IN GOOD FAITH ANY
COMMENTS PROVIDED BY ESPRIT.
IF REQUESTED BY DEPOMED, ESPRIT SHALL COOPERATE
WITH DEPOMED IN FACILITATING ANY NECESSARY FILINGS OR APPROVALS WITH THE FDA."
1.5
SECTION 20.2.
SECTION 20.2 IS HEREBY AMENDED AND RESTATED TO READ
IN ITS ENTIRETY AS FOLLOWS:
"20.2
ENTIRE AGREEMENT.
THIS AGREEMENT, THE SUPPLY AGREEMENT AND THE
CO-PROMOTION AGREEMENT REPRESENT THE ENTIRE AGREEMENT BETWEEN THE PARTIES
CONCERNING THE SUBJECT MATTER HEREIN (EXCEPT AS SPECIFICALLY NOTED HEREIN) AND
SUPERSEDES ALL PRIOR OR CONTEMPORANEOUS ORAL OR WRITTEN AGREEMENTS OF THE
PARTIES; EXCEPT THAT INFORMATION DISCLOSED PURSUANT TO THE CONFIDENTIALITY
AGREEMENT BETWEEN THE PARTIES DATED JUNE 22, 2005 SHALL CONTINUE TO BE SUBJECT
TO THE TERMS OF THAT AGREEMENT UNTIL THE EFFECTIVE DATE OF THIS AGREEMENT, FROM
WHICH DATE IT WILL BE TREATED AS PROPRIETARY INFORMATION PURSUANT TO ARTICLE 8
OF THIS AGREEMENT.
THIS AGREEMENT MAY BE MODIFIED, AMENDED OR CHANGED ONLY BY A
WRITTEN INSTRUMENT SIGNED AND DELIVERED BY THE PARTIES, WITH CLEAR INTENT TO
MODIFY, AMEND OR CHANGE THE PROVISIONS HEREOF."
2.
MISCELLANEOUS.
2.1
FULL FORCE AND EFFECT.
EXCEPT AS EXPRESSLY AMENDED HEREBY, THE
AGREEMENT WILL CONTINUE IN FULL FORCE AND EFFECT IN ACCORDANCE WITH THE
PROVISIONS THEREOF ON THE DATE HEREOF.
2.2
NO WAIVER.
DEPOMED'S AGREEMENT TO ENTER INTO THIS AMENDMENT DOES
NOT CONSTITUTE A WAIVER BY DEPOMED OF ANY DEFAULT OR BREACH OR SUCCESSION OF
DEFAULTS OR BREACHES BY ESPRIT UNDER THE LICENSE AGREEMENT, AND SHALL NOT
DEPRIVE DEPOMED OF ANY RIGHT UNDER THE LICENSE AGREEMENT OR CONTROLLING LAW IN
RESPECT OF ANY BREACH OR