EACH OTHER.
5.
MANUFACTURING AND PACKAGING.
A.
IMCOR WILL ENTER INTO A SUPPLY AGREEMENT
FOR IMAGENT WITH KYOSEI.
PRODUCT WILL BE MANUFACTURED AND SUPPLIED UNDER CGMP
GUIDELINES.
LABELING AND PACKAGING RESPONSIBILITIES WILL BE NEGOTIATED IN THE
SUPPLY AGREEMENT.
THE DEFINITIVE SUPPLY AGREEMENT WILL BE NEGOTIATED BETWEEN
THE PARTIES A TIME TO BE DETERMINED IN THE DISCRETION OF KYOSEI, BUT NO LATER
THAN THE INITIATION OF PHASE 3 CLINICAL TRIALS SUBJECT TO THE FOLLOWING TERMS:
B.
THE RIGHT TO TRANSFER MANUFACTURING TO
KYOSEI WILL BE NEGOTIATED IN THE FUTURE. KYOSEI WILL GIVE IMCOR WRITTEN
NOTIFICATION 6 MONTHS IN ADVANCE OF ITS DESIRE TO MANUFACTURE IN THE TERRITORY.
TRANSFER FEES, COSTS OF TECHNICAL TRANSFER, AND COST OF GOODS AFTER TRANSFER
WILL BE NEGOTIATED IN GOOD FAITH BY BOTH PARTIES DURING THE 6-MONTH PERIOD.
C.
UPON REASONABLE PRIOR NOTICE TO IMCOR,
KYOSEI AND ITS CONSULTANTS SHALL HAVE ACCESS TO ALL BOOKS AND RECORDS RELATING
TO THE MANUFACTURE AND SUPPLY OF IMAGENT BY IMCOR 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.
D.
UPON APPROVAL BY MHLW IN THE TERRITORY,
KYOSEI WILL PAY IMCOR AN AMOUNT EQUAL TO [****] OF THE YAKKA PRICE OF LICENSED
PRODUCT(S) FOR COMMERCIAL SHIPMENTS. IMCOR AND KYOSEI AGREE TO NEGOTIATE THE
TRANSFER COST, IF THE COST OF IMAGENT EXCEEDS AN ACCEPTABLE TRANSFER PRICE IN
THE FUTURE TO INCLUDE ANY CHANGES IN CURRENCY EXCHANGE RATES.
E.
KYOSEI WILL SUPPLY IMCOR A WRITTEN
PURCHASE ORDER FOR A 6-MONTH DEMAND FORECAST FOR IMAGENT. THE FIRST 3 MONTHS OF
THE DEMAND FORECAST WILL BE CONSIDERED BY IMCOR AS A FIRM ORDER. KYOSEI MAY
ADJUST THE SECOND 3 MONTHS OF THE DEMAND FORECAST WITH 60 DAYS WRITTEN NOTICE.
F.
IMCOR WILL NOTIFY KYOSEI OF ANY CHANGE
TO MANUFACTURING SITE, RAW MATERIALS, PACKAGING MATERIALS, OR PROCESSES TO THE
PRODUCT.
6
G.
THE SUPPLY AGREEMENT WILL PROVIDE FOR THE
ABILITY OF IMCOR TO CONTINUE TO PROVIDE PRODUCT TO KYOSEI FOLLOWING THE
TERMINATION OF THIS AGREEMENT.
6.
MARKETING AND SALES.
A.
A SEPARATE AND DEFINITIVE MARKETING AND
SALES AGREEMENT WILL BE NEGOTIATED BETWEEN THE PARTIES, AT THE DISCRETION OF
KYOSEI BUT NOT LATER THAN THE SUBMISSION OF THE NDA, SUBJECT TO THE FOLLOWING
TERMS.
B.
KYOSEI SHALL USE ITS REASONABLE BEST
EFFORTS TO DEVELOP FOR COMMERCIAL USE AND TO MARKET AND SELL LICENSED PRODUCT(S)
IN THE TERRITORY AS SOON AS PRACTICAL, CONSISTENT WITH SOUND AND REASONABLE
BUSINESS PRACTICES.
C.
KYOSEI WILL PRESENT TO IMCOR THE
MARKETING AND SALES PLAN AND BUDGET. IMCOR AND KYOSEI SHALL REVIEW THE MARKETING
PLAN ON A YEARLY BASIS IN ORDER TO OPTIMIZE CUSTOMER ACCEPTANCE AND EFFECTIVE
PROMOTION OF LICENSED PRODUCT(S). ALL FINAL PLANS, STRATEGIES AND DECISIONS
REGARDING LICENSED PRODUCT(S) MARKETING, SALES DISTRIBUTION AND PRICING SHALL BE
MADE BY KYOSEI, HOWEVER, KYOSEI WILL TAKE INTO CONSIDERATION RECOMMENDATIONS
FROM IMCOR.
D.
KYOSEI WILL BE RESPONSIBLE FOR THE SALES
AND MARKETING EXPENSES FOR LICENSED PRODUCT(S)