Provision Language
Form of Sublicense Agreement
3. Development and Registration
3.1 As of the Effective Date and subject always to MSD’s retained rights to the Patents, the Licensee shall have full control, responsibility (financial and otherwise) and authority over development, registration, importation, manufacture, and commercialisation of the Products to be sold or supplied by the Licensee in the Territory under this Agreement.
3.2 Licensee agrees that it will manufacture the Substance and the Product in a manner consistent with (i) WHO Pre-qualification standards; or (ii) the standards of any SRA. Licensee will not sell any Product without WHO Prequalification or SRA approval, or through any provisional or emergency use authorizations available through WHO or an SRA, and will comply with applicable regulatory requirements in the country of manufacturing and the country of sale.
3.3 Licensee shall submit a complete file for WHO Pre-qualification or any SRA approval within 36 months from the Effective Date for any existing formulation of the Products, or within a period to be agreed among MSD, MPP and Licensee for any new formulation of the Product. Licensee will diligently pursue such applications following submission. The Licensee agrees, where applicable and to the extent that it is able: (a) to not seek; and (b) to waive, regulatory exclusivity in the Territory in relation to any data relating to the Products.
10. Term And Termination
10.3 MPP Right to Terminate. MPP shall have the right to terminate this Agreement, either in whole or in relation to a particular Patent, with immediate effect by notice in writing to Licensee if:
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(e) Licensee fails to file for WHO Pre–Qualification of the Product within six months of a WHO Expression of Interest for the Product or such other time as may be mutually agreed between the Parties.
10.4 Failure to Promote Access. If, in the reasonable opinion of the MPP, the Licensee fails to promote access or appears in MPP’s reasonable opinion, will fail to promote access to the Products in the Territory in accordance with this Agreement, the MPP shall give notice to the Licensee requiring it to cure such failure. If, in the reasonable opinion of the MPP, the Licensee fails to present an acceptable plan within 60 days and report reasonable progress within 180 days after receiving written notice with respect to the default, the MPP shall have the right to terminate this Agreement with immediate effect by giving written notice to the Licensee. In making such determination of reasonable progress, the MPP shall take into account the period within which the relevant authorities provide the necessary approvals and normal development lead time for the Products, and progress reported by Licensee in its quarterly reports and meetings provided under Section 3.4 of this Agreement.