WHO Standard Material Transfer Agreement (SMTA 2), Pandemic Influenza Preparedness (PIP) Framework

Equitable access | Ensuring continuity

Structural Questions

Under what circumstances can the continuity rights be exercised? (What are the conditions precedent?)
What is an appropriate scope for the continuity rights? What are the rights and obligations of each party?
Should related license grants vest upon execution of the agreement, or at a later stage in development?
Should there be an escrow requirement?
Should there be any restrictions on the developer’s ability to transfer project-related intellectual property to a third party?

Annotations

This Standard Material Transfer Agreement 2 (SMTA 2) forms part of the WHO Pandemic Influenza Preparedness (PIP) Framework for the sharing of influenza viruses and access to vaccines and other benefits. The SMTA 2 is a form of agreement between the WHO and influenza product manufacturers, research institutions, or other entities (“Recipients“) that receive PIP Biological Materials from the WHO Global Influenza Surveillance and Response System (“GISRS“).

The template structure provides for Recipients to commit to at least two benefit sharing options based on their nature and capacities. The options include donation of products to WHO, reservation of products at an affordable price for WHO, and licensing and technology transfer to manufacturers in developing countries. The commitments made will be included in an Annex to be agreed between WHO and the Recipient. Recipients may only further transfer the materials with entities that have concluded SMTAs with WHO.

Details of signed agreements and benefits secured are available on the WHO website.

Provision Language

Article 4. Obligations of the Recipient

[…]

4.4 The recipient shall only further transfer the PIP biological materials if the prospective recipient has concluded an SMTA with the World Health Organization. Any such further transfer shall be reported to the World Health Organization. The Director-General may, under exceptional circumstances, allow the PIP biological materials to be transferred to a prospective recipient while requesting this aforementioned recipient to enter into an SMTA, and report to the “Advisory Group” accordingly.

4.5 The recipient may exchange PIP biological materials with any other holder of an SMTA concluded with the World Health Organization.

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WHO Standard Material Transfer Agreement (SMTA 2), Pandemic Influenza Preparedness (PIP) Framework

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WHO Standard Material Transfer Agreement (SMTA 2), Pandemic Influenza Preparedness (PIP) Framework

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