Provision Language
Definitions
“Non-Territory Patents” shall mean any Patents, granted or pending, in any country that is not included in the Territory (as hereinafter defined). For the avoidance of doubt, to the extent international and regional patent applications are included in Patents, such international and regional patent applications are Non-Territory Patents only with respect to countries not included in the Territory.
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.
4. Non–Diversion
4.1 Diversion. Licensee shall not, directly or indirectly, divert Substance and/or Product outside the Territory. Without limitation of the foregoing, except to the extent provided under this Agreement, the Licensee shall not, directly or indirectly, sell, or supply:
(a) Products or Substance outside the Territory where there is a Non–Territory Patent, for the duration of the relevant Non–Territory Patent;
(b) Substance to any Third Party in the Territory that the Licensee knows, believes or ought reasonably to suspect will sell or supply Substance outside the Territory where there is a Non–Territory Patent, for the duration of the relevant Non–Territory Patent; and/or
(c) Products to any Third Party in the Territory that the Licensee knows, believes or ought reasonably to suspect will sell or supply Products outside the Territory where there is a Non–Territory Patent, for the duration of the relevant Non– Territory Patent.
4.2 Product Labelling. The labelling of all Products sold or offered for sale under this Agreement shall expressly state that
(a) the Product is manufactured under a license from the Medicines Patent Pool; and
(b) any other use, beyond the Field, is not authorized.
4.3 Notice to Third Parties. The Licensee shall give written notice, prior to the first sale of Products, to any Third Party to which it sells Products of the restrictions contained in this Clause 4 and the Licensee shall use its best endeavors, without prejudice to any other provision of this Agreement, to ensure that such Third Parties will undertake to abide by the restrictions contained in this Clause 4 and will assist the MPP and MSD in securing compliance with this Clause 4 and the restrictions which it contemplates.
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.