Provision Language
Definitions
“Licensed Manufacturing Know-How” means all technical information and know-how known to or Controlled by BMS or its Affiliates as of the Effective Date (including all manufacturing data, the percentages and specifications of ingredients, the manufacturing process, specifications, assays, quality control and testing procedures) that is identified by BMS as primarily and directly relating to, and reasonably necessary for, the making of the Licensed Products in the same manner that such Licensed Products have been made by BMS prior to the Effective Date.
3. Technical Assistance
BMS has provided or will provide the Sublicensee with one copy of all documents, data (including, but not limited to clinical data) or other information controlled by BMS to the extent that such documents, data and information are the subject of the Licensed Manufacturing Know-How and information reasonably necessary for the registration of the Licensed Compound or a Licensed Products that is reasonably available to BMS without undue searching, provided however that the foregoing will in no event require BMS to provide copies of laboratory notebooks or manufacturing run records required to be maintained by BMS under applicable law.
Such documentation will not be used by the Sublicensee for any purpose other than the manufacture and registration of the Licensed Compound and Licensed Products in accordance with this Sublicense Agreement and is Confidential Information of BMS. Each Sublicensee shall be obligated to seek regulatory approvals within the Territory for the Licensed Products, and maintain its own regulatory documentation, provided, that if BMS has provided documentation to the Sublicensee that the Sublicensee shall leverage such documentation as it maintains its own regulatory documentation. The Sublicensee will assume full responsibility and liability to BMS for any unauthorized use or disclosure of such Confidential Information.