BALOXAVIR MARBOXIL

Additionally, if there are no patent barriers in a given country, sublicensees are free to sell or supply in that country (whether or not it is within Territory). 

Additional considerations: 

1. In the case of local and regional manufacturers, MPP may consider not only ‘demonstrated’ capacity, but ‘potential’ capacity.   

1. MPP is expressly empowered to take into account “the importance of sustainable and geographically-diversified local production of pandemic-related health products” in selecting sublicensees. 

Roche must approve the sublicensees selected by MPP, but may not unreasonably withhold or delay its approval, based only on its review of the criteria set out above. 

• Lower-middle income: 5% of net sales value 

• Upper-middle income: 10% of net sales value 

If a high-income country comes to be included in the Territory (e.g. a licensed country is reclassified by the World Bank as a high-income country; MPP & Roche expand the Territory in response to a pandemic, etc.), royalties will be calculated as 40% of net sales value. 

Notwithstanding the above, royalties are only payable on supplies in a particular country until the expiry of the last applicable patent in that country. Likewise, if there were never any applicable patents granted in that country the first place—or if the sublicensee would not infringe any relevant patents granted and in force—there is no royalty obligation. 

• formula and composition;  

• manufacturing process descriptions, specifications and methods;  

• stability data;  

• analytical method validation; and  

• discussion of impurities. 

1. Sublicensees must manufacture in a manner consistent with the standards of a Stringent Regulatory Authority, the WHO Prequalification Programme, or a WHO-Listed Authority (or an MPP Board-approved alternative). 

1. Sublicensees must submit their first complete file for regulatory approval within 36 months (however, this can be varied or waived by MPP as necessary, e.g., for local or regional manufacturers). 

1. Sublicensees cannot sell or supply licensed products prior to regulatory approval. However, the licence allows for emergency use authorisations, abbreviated regulatory approval pathways, etc. 

1. Roche will waive any regulatory exclusivities in the Territory. 

1. Roche & MPP must assess: (i) the need for pandemic-related health products containing baloxavir, both within and outside of the Territory, in consultation with WHO as appropriate; and (ii) the manufacturing capacities of both Roche and the existing sublicensees. 
2. MPP and Roche must work together with the intention of removing any access barriers including supply constraints, territory restrictions, and royalties. Roche must negotiate in good faith with MPP to respond to the health emergency and promote access to pandemic-related health products.  
3. MPP can execute additional sublicences and, in doing so, may take into account criteria other than the normal selection criteria (such criteria to be agreed with Roche) to respond effectively to the health emergency.  

Separately, all sublicensees are required to confer with WHO’s Pandemic Influenza Preparedness (PIP) Framework Secretariat within 3 months of first regulatory filing to discuss possible commitments or pandemic preparedness contributions.