APPLY TO ANY EXCLUDED PRODUCTS. FOR THE AVOIDANCE OF
DOUBT, AND CONSISTENT WITH THE DEFINITION OF EXCLUDED PRODUCTS, THIS PROVISION
IS NOT INTENDED TO PERMIT THE PROMOTION, MARKETING OR SALE OF A PRODUCT IN WHICH
THE ACTIVE INGREDIENT IS SIMPLY CO-PACKAGED AND/OR CO-ADMINISTERED WITH ANOTHER
PRODUCT CONTAINING A DIFFERENT THERAPEUTICALLY ACTIVE SUBSTANCE.
9.3.
NON-PRESCRIPTION PRODUCTS. SECTIONS 9.1 SHALL NOT APPLY IN
RELATION TO PRODUCTS FOR PROMOTION, MARKETING OR SALE WITHOUT THE LEGAL
REQUIREMENT FOR A PRESCRIPTION.
ARTICLE X.
MANUFACTURE AND SUPPLY
10.1.
GENERAL. DURING THE TERM OF THIS AGREEMENT, SEPRACOR SHALL
AT GSK'S REQUEST, AND IN ACCORDANCE WITH THE SUPPLY AGREEMENT, SUPPLY ALL OF
GSK'S, ITS AFFILIATES' AND ITS SUB-LICENSEES' REQUIREMENTS OF BULK TABLETS,
SUFFICIENT TO ENABLE GSK, ITS AFFILIATES AND ITS SUB-LICENSEES TO MEET THEIR
RESPECTIVE NEEDS FOR PRODUCT FOR THE GSK TERRITORY.
10.2.
SUPPLY AGREEMENT AND QUALITY AGREEMENT. PROMPTLY FOLLOWING
THE EFFECTIVE DATE AND WITHIN NINETY (90) DAYS THEREOF (OR AS OTHERWISE AGREED
IN WRITING BY THE PARTIES), GSK AND SEPRACOR (OR THEIR RESPECTIVE AFFILIATES)
SHALL NEGOTIATE IN GOOD FAITH AND SHALL ENTER INTO A SUPPLY AGREEMENT (THE
"SUPPLY AGREEMENT") AND A QUALITY AGREEMENT (THE "QUALITY AGREEMENT") FOR THE
SUPPLY OF BULK TABLETS BY (OR ON BEHALF OF) SEPRACOR FOR USE IN CONNECTION WITH
DEVELOPMENTAL STUDIES AND FOR COMMERCIALIZATION (INCLUDING PHYSICIAN SAMPLES) OF
THE PRODUCT IN THE GSK TERRITORY, WHICH SHALL REFLECT, AMONG OTHER THINGS, THE
TERMS OUTLINED IN SCHEDULE 10.2.
10.3.
SUPPLY PRICE.
(A)
BULK TABLETS FOR USE IN CLINICAL SUPPLIES, PHYSICIAN SAMPLES, OR
TO BE PROVIDED IN SUPPORT OF INVESTIGATOR SPONSORED CLINICAL STUDIES SHALL BE
PROVIDED AT [**]. PLACEBO FOR USE IN CLINICAL SUPPLIES OR TO BE PROVIDED IN
SUPPORT OF INVESTIGATOR SPONSORED CLINICAL STUDIES SHALL ALSO BE PROVIDED AT
[**].
(B)
ALL OTHER SUPPLIES OF BULK TABLETS SHALL BE PROVIDED AT [**].
(C)
APPROPRIATE TERMS WILL BE INCLUDED IN THE SUPPLY AGREEMENT FOR
CALCULATION OF [**] ON AN ANNUAL BASIS, USING OPEN BOOK PRICING.
CONFIDENTIAL
10.4.
MINIMUM PRICE. SUBJECT TO SECTION 10.3, NOTWITHSTANDING ANY
PROVISIONS TO THE CONTRARY IN THIS AGREEMENT, SEPRACOR SHALL NOT BE REQUIRED TO
SUPPLY BULK TABLETS TO GSK AT A COST BELOW [**].
10.5.
PRE-SUPPLY APPROVAL. GSK WILL HAVE THE RIGHT TO CONDUCT
PRE-SUPPLY APPROVAL AUDITS OF THOSE MANUFACTURING FACILITIES OF SEPRACOR, AND
ANY APPOINTED THIRD PARTY MANUFACTURER(S), WHICH ARE USED IN THE MANUFACTURE OF
BULK TABLETS FOR GSK, PRIOR TO TAKING SUPPLY. THEREAFTER, SEPRACOR SHALL NOT
APPOINT ANY OTHER THIRD PARTY MANUFACTURER NOR CHANGE THE LOCATION OF ANY PART
OF THE MANUFACTURING PROCESS FOR THE MANUFACTURE OF BULK TABLETS FOR GSK WITHOUT
GSK'S PRIOR WRITTEN CONSENT, NOT TO BE UNREASONABLY WITHHELD, AND SUBJECT TO THE
CHANGE CONTROL PROCEDURE SET OUT IN THE QUALITY AGREEMENT.
ARTICLE XI.
CONFIDENTIALITY
11.1.
CONFIDENTIAL INFORMATION. EXCEPT TO THE EXTENT EXPRESSLY
AUTHORIZED BY THIS AGREEMENT OR OTHERWISE AGREED IN WRITING, THE PARTIES AGREE
THAT THE RECEIVING PARTY (THE "RECEIVING PARTY") SHALL KEEP CONFIDENTIAL AND
SHALL NOT PUBLISH OR OTHERWISE DISCLOSE OR USE FOR ANY PURPOSE OTHER THAN AS
PROVIDED FOR IN THIS AGREEMENT ANY CONFIDENTIAL