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.
BMS – MPP Agreement
3. TECHNICAL ASSISTANCE
3.1 Documentation
(a) BMS will provide the MPP 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 Product 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. BMS will further provide the MPP and its Sublicensees with regulatory exclusivity waivers, as applicable, to the extent required by the Regulatory Authorities for national registration in the Territory of the Licensed Products. BMS shall not be responsible for the performance of additional studies or submission of additional data for the grant of the regulatory approval of a Licensed Product in the Territory.
(b) Such documentation will not be used by the MPP or any of its Sublicensees for any purpose other than the manufacture and registration of the Licensed Compound and Licensed Products in accordance with this License Agreement and is Confidential Information of BMS. For the sake of clarity, each Sublicensee shall be obligated to seek regulatory approvals within the Territory for the Licensed Product, and maintain its own regulatory documentation, provided, that if BMS has provided documentation to the Sublicesee that the Sublicensee shall leverage such documentation as it maintains its own regulatory documentation. Each Sublicensee will assume full responsibility and liability to BMS for any unauthorized use or disclosure of such Confidential Information.
(c) BMS will be responsible for the cost of providing one set of electronic copies only. BMS will respond to reasonable requests from the MPP or its Sublicensees for clarification on the information provided under this Section 3.1(c), where responses to such requests are, in BMS’ good faith judgment reasonably necessary for the manufacture and registration (in the manner previously manufactured by or for BMS) of the Licensed Compound or a Licensed Product.
(d) Any and all such materials delivered to the MPP pursuant to this Section 3 are and will remain the sole property of BMS. BMS represents and warrants that the information provided to MPP pursuant to this Section 3 will be true, to the best of BMS’s knowledge, as of the date of such documentation.
3.2 Technical Transfer Package
(a) MPP will require the Sublicensees to accept the technical transfer package set out in Schedule F (the Technical Transfer Package) relating to the Licensed Manufacturing Know-How.
(b) Each Sublicensee will evaluate the contents of the Technical Transfer Package with a view to taking a technical decision whether or not to use such contents in the manufacture of the Licensed Compound and Licensed Products. Irrespective of its decision whether to use the Technical Transfer Package or not, the Sublicensee should be in a position to make or have made generic equivalents of the Licensed Compound and the Licensed Products. In the event that it is alleged that the Sublicensee relied on the Licensed Manufacturing Know-How in breach of its obligations under this Sublicense Agreement or for purposes not contemplated in this Sublicense Agreement, the defenses set out in Section 10.1(b) will be available to the Sublicensee.
Form of Sublicense
3. TECHNICAL ASSISTANCE
3.1 Documentation
(a) 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 Product 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. BMS will further provide the Sublicensee with NCE or other regulatory exclusivity waivers, as applicable, to the extent required by the Regulatory Authorities for national registration in the Territory of the Licensed Products. BMS shall not be responsible for the performance of additional studies or submission of additional data for the grant of the regulatory approval of a Licensed Product in the Territory.
(b) 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. For the sake of clarity, each Sublicensee shall be obligated to seek regulatory approvals within the Territory for the Licensed Product, and maintain its own regulatory documentation, provided, that if BMS has provided documentation to the Sublicesee 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.
(c) BMS will be responsible for the cost of providing one set of electronic copies only. BMS will respond to reasonable requests from the Sublicensee for clarification on the information provided under this Section 3.1(c), where responses to such requests are, in BMS’s good faith judgment reasonably necessary for the manufacture and registration (in the manner previously manufactured by or for BMS) of the Licensed Compound or a Licensed Product.
(d) Any and all such materials delivered to the Sublicensee pursuant to this Section 3 are and will remain the sole property of BMS. BMS represents and warrants to the Sublicensee that the information provided to Sublicensee pursuant to this Section 3 will be true, to the best of BMS’s knowledge, as of the date of such documentation.
3.2 Technical Transfer Package
(a) The Sublicensee undertakes to accept the technical transfer package set out in Schedule G (the Technical Transfer Package) and relating to the Licensed Manufacturing Know-How.
(b) The Sublicensee will evaluate the contents of the Technical Transfer Package with a view to taking a technical decision whether or not to use such contents in the manufacture of the Licensed Compound and Licensed Products. Irrespective of its decision whether to use the Technical Transfer Package or not, the Sublicensee should be in a position to make or have made generic equivalents of the Licensed Compound and the Licensed Products. In the event that it is alleged that the Sublicensee relied on the Licensed Manufacturing Know-How in breach of its obligations under this Sublicense Agreement or for purposes not contemplated in this Sublicense Agreement, the defenses set out in Section 10.1(b) will be available to the Sublicensee.