Provision Language
Definitions
“ViiV Product” means a Product manufactured by or on behalf of a ViiV Healthcare Group company.
5. Assistance with Product Development and Regulatory Approvals
Data Package
5.1 In the event the MPPF receives (pursuant to Clause 5 of a Sublicence) a written request for ViiV to provide a data package to expedite development and filing for Regulatory Approval in the Territory, the MPPF shall promptly forward such request to ViiV. Upon receipt of the request, ViiV shall consider the request and, if ViiV in its sole discretion considers it feasible to do so, ViiV shall assemble and make available to each Sublicensee a single discrete data package, which (i) content shall be determined by ViiV in its sole discretion, and (ii) provision shall be conditional on such Sublicensee entering into a separate non-disclosure agreement with ViiV regarding the data package.
ViiV Products
5.2 ViiV commits to sell to each Sublicensee, at a discounted price to be determined by ViiV at its sole discretion, and subject to terms to be agreed between ViiV and such Sublicensee, up to 1000 tablets of oral cabotegravir (30mg tablets) and up to 1000 vials of extended-release injectable suspension of cabotegravir (600mg/3mL vials), solely for use in (a) in vitro research related to the Sublicensee’s Licenced Product development and (b) bioequivalence studies required to obtain Regulatory Approval. In the event the MPPF receives (pursuant to Clause 5 of a Sublicence) a written request for ViiV to sell ViiV Product to a Licensee, the MPPF shall promptly forward such request to ViiV. The MPP shall ensure that as part of any request, a Sublicensee provides details of its (a) development plan and associated milestones and (b) bioequivalence study plans. ViiV shall work directly with the relevant Sublicensee to agree the terms of such sale.
Schedule 2 – Form of Sublicense
5. REFERENCE PRODUCT AND DATA PACKAGE
In the event that the Licensee:
(a) wishes to procure ViiV Product directly from ViiV for use in bioequivalence studies required to obtain Regulatory Approval; and/or
(b) would like ViiV to consider providing the Licensee with a data package to expedite filing for Regulatory Approval,
Licensee shall submit a written request for the same (which shall, for any request to procure ViiV Product, include the details of the Licensee’s (a) development plan and associated milestones and (b) bioequivalence study plans) to the Licensor. Upon receipt of such request, the Licensor shall forward the request to ViiV for consideration under Clauses 5.1 and 5.2 of the Head Licence (as applicable), and keep Licensee informed of progress and outcome of the request.