OF IMAGENT [****]
UNTIL LICENSED PRODUCT(S) IS APPROVED IN THE TERRITORY. IMAGENT WILL BE SHIPPED,
FOB ORIGIN, TO KYOSEI'S SINGLE DESIGNATED SHIPPING POINT WITHIN 30 DAYS OF THE
RECEIPT BY IMCOR OF A PURCHASE ORDER FROM KYOSEI. IMAGENT SHIPMENTS FOR
PRE-CLINICAL AND CLINICAL USE WILL BE PROVIDED IN THE U.S. LABELED AND FINISHED
KIT PRODUCT.
PRODUCT WILL BE MANUFACTURED AND SUPPLIED UNDER CGMP GUIDELINES.
D.
IMCOR SHALL MAKE ITS PERSONNEL AVAILABLE
AT REASONABLE TIMES FOR ORIENTATION AND TRAINING WITH RESPECT TO THE USE OF
IMAGENT IN PRECLINICAL AND CLINICAL TESTING. EACH PARTY SHALL BEAR IT'S OWN
RESPECTIVE EXPENSES FOR TRAINING.
E.
KYOSEI WILL PROVIDE TO IMCOR THE 6-MONTH
PRE-CLINICAL AND CLINICAL DEMAND FOR LICENSED PRODUCT(S) TWO (2) MONTHS IN
ADVANCE.
THE FIRST TWO MONTHS OF WHICH WILL BE CONSIDERED BY IMCOR AS A FIRM
ORDER. KYOSEI MAY UPON WRITTEN REQUEST ADJUST THE SECOND THREE MONTHS WITHIN 60
DAYS OF THE FIRST SHIPMENT.
F.
KYOSEI WILL USE ITS REASONABLE BEST
EFFORTS TO CLINICALLY DEVELOP IMAGENT IN THE TERRITORY, TO INCLUDE THE
DEVELOPMENT OF INDICATIONS IN THE FIELD OF USE OF MEDICINE.
G.
EACH PARTY WILL USE ITS REASONABLE BEST
EFFORTS TO PROVIDE ADVERSE EVENTS REPORTING FOR IMAGENT AS OUTLINED IN EXHIBIT
B.
H.
KYOSEI WILL MAINTAIN AND CAUSE ITS
SUBLICENSEES TO MAINTAIN, COMPLETE AND ACCURATE BOOKS AND RECORDS, AS REQUIRED
BY JAPANESE AUTHORITIES WHICH ENABLE THE APPROVAL AND SALE OF LICENSED
PRODUCT(S).
THE RECORDS SHALL BE MAINTAINED FOR TEN YEARS AFTER THE SUBMISSION
OF EACH REPORT UNDER SECTION [4] HEREOF.
UPON REASONABLE PRIOR NOTICE TO
KYOSEI, IMCOR AND ITS CLINICAL AND REGULATORY CONSULTANTS SHALL HAVE ACCESS TO
ALL BOOKS AND RECORDS RELATING TO THE CLINICAL AND REGULATORY DEVELOPMENT OF
IMAGENT BY KYOSEI AND ITS SUBLICENSEES TO CONDUCT A REVIEW OR AUDIT THEREOF.
SUCH ACCESS SHALL BE AVAILABLE NOT MORE THAN ONCE EACH YEAR, DURING NORMAL
BUSINESS HOURS, AND FOR FIVE YEARS AFTER THE EXPIRATION OR TERMINATION OF THIS
AGREEMENT.
5
I.
ANY MODIFICATION OR IMPROVEMENT TO
TECHNICAL INFORMATION USED TO PRODUCE LICENSED PRODUCT(S) MADE BY IMCOR BEFORE
THE TERMINATION OF THIS AGREEMENT SHALL BE INCLUDED IN THE LICENSE GRANTED
WITHOUT ADDITIONAL CHARGE TO KYOSEI.
IN ADDITION, KYOSEI WILL PROMPTLY DISCLOSE
AND HEREBY GRANTS BACK TO IMCOR A WORLDWIDE (EXCEPT FOR JAPAN), ROYALTY-FREE,
EXCLUSIVE, SUBLICENSABLE LICENSE TO FULLY EXPLOIT ANY MODIFICATIONS OR
IMPROVEMENTS MADE BY OR FOR KYOSEI DURING THE SAME PERIOD.
THE FOREGOING SHALL
BE DEEMED TO INCLUDE, WITHOUT LIMITATION, (A) ANY PATENT COVERING AN INVENTION
THE MANUFACTURE, USE OR SALE OF WHICH WOULD BE COVERED BY OR WITHIN THE SCOPE OF
A CLAIM OF A PATENT LICENSED TO KYOSEI HEREUNDER AND (B) ANY PATENT THAT (ALONE
OR TOGETHER WITH OTHERS) TENDS TO DEFINE, DESCRIBE OR SURROUND ANY PART OF
IMCOR'S TECHNICAL INFORMATION OR ANY INVENTION CLAIMED IN A PATENT LICENSED TO
KYOSEI HEREUNDER) AND KYOSEI SHALL NOT, EXCEPT IN JAPAN, LICENSE TO THIRD
PARTIES THE MODIFICATIONS OR IMPROVEMENTS DERIVED FROM OR BASED ON ANY OF
IMCOR'S TECHNICAL INFORMATION. THE PARTIES AGREE TO PROMPTLY DISCLOSE SUCH
MODIFICATIONS AND IMPROVEMENTS TO