Provision Language
4. Technical Assistance
4.1 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 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 and are 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.
7. Pharmacovigilance and Quality Matters
7.1 Pharmacovigilance
(a) If the Sublicensee becomes aware of any adverse reaction relating to the Licensed Compound or Licensed Products in connection with this Sublicense Agreement, the Sublicensee must inform BMS within 24 hours of its becoming aware and cooperate with BMS in fulfilling BMS’s reporting responsibilities under applicable laws and regulations.
(b) The Sublicensee will maintain effective and reliable systems for receiving and tabulating any reports of adverse reactions to the Licensed Products and to report such information on a timely basis to the relevant authorities and to BMS pursuant to the terms of this Sublicense Agreement.
10. Audit and Reports
10.1 Reports. The Sublicensee will send to MPP within 10 Business Days following the end of each calendar quarter the number of units of Licensed Products sold by strength / formulation by country and the amount of royalties payable and collected as a result of the sales thereof. The Sublicensee shall also provide MPP with a quarterly written report setting forth (a) Licensed Products in its development pipeline, (b) status of development of each Licensed Product in development, (c) regulatory filing plan for each Licensed Product, and (d) a list of countries within the Territory for which such regulatory approvals or authorizations have been obtained for any Licensed Product. The Sublicensee and MPP agree to confer on a quarterly basis regarding such reports and also review development and filing status of Licensed Products. MPP agrees that information contained in quarterly and other such reports shall be treated as Confidential Information.