Provision Language
Article 4. Obligations of the Recipient
4.1 The recipient agrees to comply with the commitments selected below, in accordance with the terms set out in the Annex to this agreement.
4.1.1 The recipient shall comply with the commitments selected on a timetable determined by the WHO in consultation with the Advisory Group established by the PIP Framework and in coordination with the recipient, based on optimal pandemic preparedness and response considerations.
A. For manufacturers of vaccines and/or antivirals, the recipient shall commit to at least two of the following options:
A1. Donate at least 10%¹ of real time pandemic vaccine production to WHO.
A2. Reserve at least 10%¹ of real time pandemic vaccine production at affordable prices to WHO.
A3. Donate at least X treatment courses of needed antiviral medicine for the pandemic to WHO.
A4. Reserve at least X treatment courses of needed antiviral medicine for the pandemic at affordable prices.
A5. Grant to manufacturers in developing countries licenses on mutually agreed terms that should be fair and reasonable including in respect of affordable royalties, taking into account development levels in the country of end use of the products, on technology, know-how, products and processes for which it holds IPR for the production of (i) influenza vaccines, (ii) adjuvants, (iii) antivirals and/or (iv) diagnostics.
A6. Grant royalty-free licenses to manufacturers in developing countries or grant to WHO royalty-free, non-exclusive licenses on IPR, which can be sublicensed, for the production of pandemic influenza vaccines, adjuvants, antivirals products and diagnostics needed in a pandemic. WHO may sublicense these licenses to manufacturers in developing countries on appropriate terms and conditions and in accordance with sound public health principles.
Where Option 5 or 6 is selected, the Recipient shall regularly provide to WHO information on granted licenses and the status of implementation of the licensing agreement. WHO shall provide such information to the Advisory Group.
B. Manufacturers of products relevant to pandemic influenza preparedness and response, that are not manufacturing vaccines or antivirals, shall commit to one of the following options: A5, A6, B1, B2, B3, B4.
B1. Donate to WHO at least X² diagnostic kits needed for pandemics.
B2. Reserve for WHO at least X² diagnostic kits needed for pandemics, at affordable prices.
B3. Support, in coordination with WHO, the strengthening of influenza specific laboratory and surveillance capacity in developing countries.
B4. Support, in coordination with WHO, transfer of technology, know-how and/or processes for pandemic influenza preparedness and response in developing countries.
C. The recipient shall, in addition to the commitments selected under A or B above, consider contributing to the measures listed below, as appropriate:
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- Donations of vaccines;
- Donations of pre-pandemic vaccines;
- Donations of antivirals;
- Donations of medical devices;
- Donations of diagnostic kits;
- Affordable pricing;
- Transfer of technology and processes;
- Granting of sublicenses to WHO;
- Laboratory and surveillance capacity building.
¹ Recognizing that flexibility is important in negotiating with all manufacturers, in a range of 5–20%.
² Recognizing that flexibility is important in negotiating with all manufacturers.