Standard Material Transfer Agreement outside WHO GISRS (SMTA 2)
Article 1. Parties to the Agreement
WHO and Recipient.17
Article 2. Subject matter of the Agreement
PIP biological materials as defined in Section 4.1 of the Framework (hereinafter “Materials”) transferred to the Recipient are subject to the provisions of this Agreement.
Article 2. bis Definitions
(a) As provided for in Section 4 of the Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other benefits.
(b) Other terms as agreed by the parties.
Article 3. Obligations of the Provider
To be agreed by the parties.
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%18 of real time pandemic vaccine production to WHO
A2. Reserve at least 10%316 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 314 Recipients are all entities that receive “PIP Biological Materials” from the WHO GISRS, such as influenza vaccine, diagnostic and pharmaceutical manufacturers, as well as biotechnology firms, researchinstitutions and academic institutions. Each recipient shall select options based on its nature and capacities.2 Recognizing that flexibility is important in negotiating with all manufacturers, in a range of 5-20%.19 Recognizing that flexibility is important in negotiating with all manufacturers, in a range of 5?20%. 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 X317 diagnostic kits needed for pandemics
B2. Reserve for WHO at least X318 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:
? Donations of vaccines
? Donations pre-pandemic vaccines 1 2
? 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.
4.2 The Recipient shall ensure that the PIP biological materials are handled in accordance with applicable WHO guidelines and national bio-safety standards.
4.3 If applicable, the Recipient shall appropriately acknowledge in presentations and publications, the contributions of WHO laboratories providing the materials identified in Article 2, using existing scientific guidelines.20 Recognizing that flexibility is important in negotiating with all manufacturers. Recognizing that flexibility is important in negotiating with all manufacturers.21
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.
Article 5. Dispute Resolution
If a dispute cannot be resolved through negotiations or other non-binding means of the parties’ choice, disputes shall be subject to binding arbitration on conditions that are mutually agreed by the parties.
Article 6. Liability and Indemnity
To be agreed by the parties.
Article 7. Privileges and Immunity
Nothing in or relating to these clauses shall imply the obligation of WHO to submit to any national legislation or jurisdiction, or be deemed a waiver of any of the privileges and immunities of WHO in conformity with the Convention on the Privileges and Immunities of the Specialized Agencies approved by the General Assembly of the United Nations on November 21, 1947 or otherwise under any national or international law, convention or agreement.
Article 8. Name and Emblem
To be agreed by the parties.
Article 9. Warranties
To be agreed by the parties
Article 10. Duration of Agreement
To be agreed by the parties.
Article 11. Termination
To be agreed by the parties.
Article 12. Force Majeure
To be agreed by the parties.
Article 13. Governing law
To be agreed by the parties.
Article 14. Signature and Acceptance
In WITNESS
Whereof, this Agreement has been duly executed by the parties.
SIGNED for and on behalf of WHO
Signature
Name Title
SIGNED for and on behalf of Recipient
Signature
Name Title
*********************
Annex To be agreed by the parties.
17 Recipients are all entities that receive “PIP Biological Materials” from the WHO GISRS, such as influenza vaccine, diagnostic and pharmaceutical manufacturers, as well as biotechnology firms, research institutions and academic institutions. Each recipient shall select options based on its nature and capacities.
18 Recognizing that flexibility is important in negotiating with all manufacturers, in a range of 5-20%.
19 Recognizing that flexibility is important in negotiating with all manufacturers, in a range of 5?20%.
20 Recognizing that flexibility is important in negotiating with all manufacturers.
21 Recognizing that flexibility is important in negotiating with all manufacturers.
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