Master Alliance Provisions Guide (MAPGuide)

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Agreement title
Effective date
Partner type
Technology
Development stage
Adjuvant Global Health Technology Fund - AN2 Therapeutics, Melioidosis & Tuberculosis Therapeutic (Epetraborole) Global Health Agreement
2021
Funder
Industry
Drug
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
European Commission - CureVac, COVID-19 Vaccine Advance Purchase Agreement
2020
Government
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
European Commission - AstraZeneca, COVID-19 Vaccine Advance Purchase Agreement
2020
Government
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Alnylam Pharmaceuticals - University of British Columbia- AlCana Technology, Sponsored Research Agreement
2009
Academic institution
Industry
Drug
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
PATH - Aridis, Rotavirus Vaccine Development Agreement
2007
Industry
Product development partnership
Vaccine
Early clinical (through Phase 2)
UK Secretary of State - AstraZeneca, COVID-19 Vaccine Supply Agreement
2020
Government
Industry
Vaccine
Commercialization
AUTM Model Inter-Institutional Research Collaboration Agreement
2015
Academic institution
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
AUTM Preliminary Patent Management Agreement
2013
Academic institution
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
US Department of Defense - Moderna, COVID-19 Vaccine Supply Agreement
2020
Government
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
AXA Prime Impact Master Fund - Revelation Biosciences, Diagnostics & Therapeutics for Viral Infections, Global Health Agreement
2020
Funder
Industry
Diagnostic
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Yale University - BIND Biosciences, Cancer Therapeutic, Exclusive License Agreement
2013
Academic institution
Industry
Drug
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Biological E - Dynavax Technologies, COVID-19 Vaccine Adjuvant Supply Agreement
2021
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Gates Foundation - Arsanis RSV Monoclonal Antibodies Funding Agreement
2017
Funder
Industry
Drug
Preclinical
Gates Foundation - Arsanis, S. Aureus Antibody Strategic Relationship Letter Agreement
2017
Funder
Industry
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Gates Foundation - CureVac, Global Access Commitments Agreement
2015
Funder
Industry
Drug
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Gates Foundation - CureVac - GSK, Letter Agreement for Alignment on Global Access Commitments
2020
Funder
Industry
Drug
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Gates Foundation - Icosavax, COVID-19 Vaccine Global Access and Price Commitments Agreement
2021
Funder
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Boston University Startup Exclusive License Template
2012
Academic institution
Industry
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
CARB-X Portfolio Company Agreement Template
2019
Academic institution
Funder
Industry
Non-profit research organization
Product development partnership
Diagnostic
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
CAVD Data & Materials Sharing Agreement
2006
Academic institution
Funder
Government
Industry
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Cellscript - BioNTech mRNA Technology Patent Sublicense
2016
Industry
Vaccine
Preclinical
CEPI CfP3i Vaccine Funding Agreement Template
2018
Funder
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
CEPI - CureVac, Framework Partnering Agreement
2019
Funder
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
CEPI - Dynavax, COVID-19 Material Reservation Agreement
2021
Funder
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
CEPI - University of Oxford - Barinthus Biotherapeutics, ChAdOx1 MERS Vaccine R&D Funding Agreement
2023
Academic institution
Funder
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
CEPI - Valneva, Chikungunya Vaccine Funding Agreement
2019
Funder
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
CEPI - VBI, COVID-19 Vaccine Development Funding Agreement
2021
Funder
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Sanofi - Translate Bio, Influenza and COVID-19 Vaccine Collaboration & License Agreement
2020
Industry
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
CSIC - MPP (C-TAP), COVID-19 Vaccine, Patent and Material License Agreement
2023
Government
Multilateral organization
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
CSIC - MPP (C-TAP), COVID-19 Diagnostic, Patent & Material License Agreement
2021
Government
Multilateral organization
Diagnostic
Commercialization
CureVac - GSK, COVID-19 Vaccine Collaboration and License Agreement
2021
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
DNDi Template Development Collaboration and License Agreement
2023
Academic institution
Industry
Non-profit research organization
Product development partnership
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
DNDi Template Research Collaboration and License Agreement
2023
Academic institution
Industry
Non-profit research organization
Product development partnership
Drug
Discovery/Concept
Preclinical
DNDi - BioDelivery Sciences International, Visceral Leishmaniasis Research Collaboration Agreement
2009
Industry
Product development partnership
Drug
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
WHO - Manufacturer, Ebola Products Collaboration LOA Template
2015
Academic institution
Industry
Multilateral organization
Non-profit research organization
Product development partnership
Drug
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Elkurt - Ocean Biomedical, Malaria Vaccine, Exclusive License Agreement
2021
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
DNDi/GARDP - Entasis, Gonorrhoea Medication, Collaboration Agreement
2017
Industry
Product development partnership
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
FIND Sample Funding Terms and Conditions
2021
Academic institution
Industry
Product development partnership
Diagnostic
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Fiocruz - AstraZeneca, COVID-19 Technological Order Agreement
2021
Government
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Fiocruz - AstraZeneca, COVID-19 Vaccine Technology Transfer Agreement
2021
Government
Industry
Vaccine
Commercialization
Funder Development Partnering Agreement Template
2018
Funder
Industry
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
GARDP – Orchid Pharma Ltd., Cefiderocol Manufacturing Sublicense and Technology Transfer Agreement
2023
Funder
Industry
Drug
Commercialization
Gates Foundation - Amyris, Inc., Malaria Therapeutic (artemisinin-based combination therapies - ACTs), Letter Agreement
2016
Funder
Industry
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Gates Foundation - BioNTech, TB & HIV Product Strategic Letter Agreement
2019
Funder
Industry
Drug
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Gates Foundation - Icosavax, COVID-19 Vaccine Grant Agreement
2021
Funder
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Gates Foundation - Novavax, RSV Vaccine Global Access Commitments Agreement
2015
Funder
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Gates Foundation Sample Grant Terms & Conditions
2019
Academic institution
Funder
Industry
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Gates Foundation - Visterra, Strategic Relationship Letter Agreement
2012
Funder
Industry
Drug
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Gavi Alliance - Novavax, COVID-19 Vaccine Advance Purchase Agreement
2021
Industry
Multilateral organization
Vaccine
Late clinical (Phase 3)
Commercialization
Gilead, HIV Therapeutic (Lenacapavir) Template License Agreement
2024
Industry
Drug
Late clinical (Phase 3)
Commercialization
Gilead Hepatitis C (HCV) Therapeutics License Agreement
2014
Industry
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
IAVI - Theraclone Sciences, HIV Research Collaboration Agreement
2009
Industry
Product development partnership
Diagnostic
Drug
Vaccine
Discovery/Concept
IMI 1 Model Grant Agreement
2011
Academic institution
Funder
Industry
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
IMI 2 JU Model Consortium Agreement
2017
Academic institution
Industry
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
IMI 2 Model Grant Agreement
2017
Academic institution
Funder
Industry
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
India Department of Biotechnology (DBT), Memorandum of Agreement
2023
Academic institution
Government
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Israel - Pfizer, Epidemiological Evidence Collaboration Agreement
2021
Government
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Field Testing
Lambert Toolkit, Consortium Agreement D Template
2019
Academic institution
Industry
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Merck - Bioprotection Systems Corp., Ebola Vaccine License & Collaboration Agreement
2014
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
BARDA - Moderna, COVID-19 Vaccine Development Agreement
2020
Government
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Moderna – Lonza, COVID-19 mRNA Vaccine & Therapies, Manufacturing & Process Development Agreement
2020
Industry
Drug
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
AbbVie – MPP, HIV Antiretroviral (lopinavir, ritonavir - LPV/r) License Agreement
2016
Industry
Multilateral organization
Drug
Commercialization
AbbVie - MPP, HIV Antiretroviral (lopinavir, ritonavir - LPV/r) Pediatric License Agreement
2014
Industry
Multilateral organization
Drug
Commercialization
MPP – Afrigen Biologics, COVID-19 mRNA-Based Vaccines and Therapeutics, Grant Agreement
2022
Industry
Multilateral organization
Drug
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
MPP – Afrigen Biologics, RSV mRNA-Based Vaccine, Grant Agreement
2023
Industry
Multilateral organization
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
MPP - Biovac, mRNA Vaccine Technology Transfer Agreement
2024
Industry
Multilateral organization
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
BMS - MPP, Hepatitis C Antiviral (daclatasvir - DAC) License & Tech Transfer Agreement
2016
Industry
Multilateral organization
Drug
Commercialization
BMS - MPP, HIV Antiretroviral (atazanavir - ATV) License and Technology Transfer Agreement
2017
Industry
Multilateral organization
Drug
Commercialization
MPP (C-TAP) - Biotech Africa, COVID-19 Diagnostic, Patent & Material Sublicense Agreement
2022
Industry
Multilateral organization
Diagnostic
Commercialization
Medigen - MPP (C-TAP), COVID-19 Vaccine, Patent and Know How License Agreement
2023
Industry
Multilateral organization
Vaccine
Commercialization
MPP - Gates Medical Research Institute, TB therapeutic (Sutezolid) Sublicense Agreement
2020
Industry
Multilateral organization
Non-profit research organization
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Gilead - MPP - Arene Lifesciences, HIV Therapeutic License Agreement
2018
Industry
Multilateral organization
Drug
Commercialization
Pfizer - MPP, TB Therapeutic (Sutezolid) Non-Exclusive License Agreement
2019
Industry
Multilateral organization
Drug
Commercialization
MPP – South African Medical Research Council, COVID-19 mRNA-Based Vaccines and Therapeutics, Grant Agreement
2022
Government
Multilateral organization
Drug
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
University of Liverpool – MPP, HIV Therapeutic Collaboration Agreement and Patent & Know-How License
2015
Academic institution
Multilateral organization
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
ViiV - MPP, Dolutegravir License Agreement
2016
Industry
Multilateral organization
Drug
Commercialization
Merck - MPP, Molnupiravir License Agreement
2021
Industry
Multilateral organization
Drug
Late clinical (Phase 3)
Commercialization
US Department of Defense - Ology Bioservices, COVID-19 Plasmid Procurement Agreement
2020
Government
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
National Health Service (NHS) – Pfizer/Shionogi, Antibiotic Supply Agreement
2022
Government
Industry
Drug
Commercialization
NIAID - AbCellera, COVID-19 Exclusive Patent License Agreement
2020
Government
Industry
Vaccine
Commercialization
PHS - Biosyn, HIV Prophylactic Exclusive License Agreement
2003
Government
Industry
Device
Drug
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
NIH - GeoVax, Non-Exclusive Patent and Biological Materials License Agreement
2020
Government
Industry
Vaccine
Preclinical
Commercialization
NIH - Non-Profit, Model License Agreement Terms
2017
Government
Multilateral organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
NIH – MPP (C-TAP), COVID-19 Technologies, Patent and Biological Material License Agreement
2022
Government
Multilateral organization
Diagnostic
Drug
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
NIH - UniQure, AAV5 Gene Therapies Exclusive and Non-Exclusive License Agreement
2011
Government
Industry
Drug
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Novartis – MPP, Nilotinib, Non-Exclusive License Agreement
2022
Industry
Multilateral organization
Drug
Commercialization
CEPI - Novavax, COVID-19 Vaccine Funding Agreement
2020
Funder
Industry
Vaccine
Commercialization
Novavax - Serum Institute of India, COVID-19 Vaccine Supply and License Agreement
2020
Industry
Vaccine
Commercialization
US Department of Defense - Novavax, COVID-19 Vaccine Development Agreement
2020
Government
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Ocugen-BBIL, COVID-19 Vaccine (Covaxin), Co-development, Supply & Commercialization Agreement
2021
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Dominican Republic Ministry of Health - Pfizer/BioNTech, COVID-19 Vaccine Binding Term Sheet
2021
Government
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Peru Ministry of Health - Pfizer/BioNTech, COVID-19 Vaccine Binding Term Sheet
2021
Government
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
PHS - Aridis, Rotavirus Vaccine Exclusive and Non-Exclusive License Agreement
2005
Government
Industry
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
PHS (NIH/CDC/FDA), Model Exclusive Patent License Agreement
2015
Academic institution
Government
Industry
Multilateral organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
PHS (NIH/CDC/FDA), Model Non-Exclusive Patent License Agreement
2015
Academic institution
Government
Industry
Multilateral organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Population Council - TherapeuticsMD, Nestorone Contraceptive Ring, License Agreement
2018
Industry
Non-profit research organization
Device
Commercialization
Field Testing
Public Health England, Model Fast Track Testing & Evaluation Agreement
2014
Academic institution
Government
Industry
Non-profit research organization
Product development partnership
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Academic Institution - Company, Research Collaboration Agreement
2016
Academic institution
Industry
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
US Department of Defense – Regeneron, COVID-19 Antibodies Large-Scale Manufacturing Agreement
2020
Government
Industry
Drug
Late clinical (Phase 3)
Commercialization
Roche - PTC Therapeutics - Spinal Muscular Atrophy Foundation, SMA Therapeutic License and Collaboration Agreement
2011
Funder
Industry
Non-profit research organization
Drug
Late clinical (Phase 3)
Commercialization
US Department of Defense - Sanofi, COVID-19 Vaccine Development Agreement
2020
Government
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Shionogi - GARDP, Cefiderocol License Agreement
2022
Industry
Product development partnership
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Spinal Muscular Atrophy Foundation - PTC Therapeutics, Spinal Muscular Atrophy Therapeutics Sponsored Research Agreement
2006
Industry
Non-profit research organization
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
US Department of Defense - Inovio, COVID-19 Vaccine Delivery Device, Other Transaction Prototype Agreement
2020
Government
Industry
Device
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
UC Berkeley, Therapeutics & Diagnostics, Exclusive License Agreement Template
2023
Academic institution
Industry
Diagnostic
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
UK Medical Research Council - Indevus Pharmaceuticals, Antiviral Microbicide, Collaborative Research and Licensing Agreement
2005
Government
Industry
Drug
Late clinical (Phase 3)
UnitaidExplore Sample Funding Terms and Conditions
2020
Academic institution
Funder
Industry
Product development partnership
Device
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
University of Chile - MPP (C-TAP), COVID-19 Diagnostic Material & Know-How License Agreement
2023
Academic institution
Multilateral organization
Diagnostic
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
University of Washington - MPP, Long-acting Injectable HIV Treatment License Agreement
2021
Academic institution
Multilateral organization
Drug
Preclinical
US Department of Defense - Janssen, COVID-19 Vaccine Large Scale Manufacturing Agreement
2020
Government
Industry
Vaccine
Commercialization
Wellcome Trust - Alto Neuroscience, Bipolar Depression Therapeutic Convertible Loan Agreement
2024
Funder
Industry
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Wellcome Trust - PTC Therapeutics, Cancer Treatment Research Funding Agreement
2010
Funder
Industry
Drug
Discovery/Concept
Preclinical
Wellcome Trust Standard Grant Terms & Conditions
2021
Academic institution
Funder
Industry
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
WHO Confidential Disclosure Agreement Template
2015
Academic institution
Industry
Multilateral organization
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
WHO Standard Framework MoU
2015
Multilateral organization
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
WHO Template Collaboration Agreement
2015
Academic institution
Industry
Multilateral organization
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
WHO Template Material Transfer Agreement
2015
Academic institution
Industry
Multilateral organization
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
UK Secretary of State - Roche, REGN-COV2 Supply Agreement
2021
Government
Industry
Drug
Late clinical (Phase 3)
Commercialization
NIH - Fluidigm, COVID-19 Diagnostic Development Agreement
2020
Government
Industry
Diagnostic
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization

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 	What is the scope of confidential information?
 	What are the obligations of the parties to protect confidential information?
 	Are there any exceptions to the confidentiality obligations?
 	Are the parties permitted to make public announcements related to the project?
 	Can the parties use each other’s name and logo for general marketing materials?

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 	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?

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 	Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
 	What are the resolution mechanisms for disputes related to the agreement?
 	Are there any requirements for policies or procedures to manage potential conflicts of interest?

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 	What is the process for managing liability claims?
 	Are there government or other types of indemnification schemes?
 	Is there any limitation or monetary cap on each party’s liabilities under the agreement?

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 	What financial and project progress information must be shared between the parties?
 	What is the required timeline for sharing information?
 	How is the receiving party permitted to use the information received?
 	Do the parties have the right to verify the information reported?

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 	What is the scope of the licensed intellectual property?
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 	Are there any restrictions on the use of the licensed intellectual property?
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What are the mechanisms to limit exposure to additional payments or expenses?
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What is the required timeline for making data available?
What are the acceptable publication channels?
Is compliance with a specific open access policy required?
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 	What is the term of the agreement? Is it tied to the timeline of the project or license grants?

Termination

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Effects of Termination

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 	Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
 	Should the developer be required to identify a third party that could fulfill supply requirements for the access territories in the event that the developer does not?
 	Should the agreement include any anti-diversion provisions?

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 	How should equitable or global access be defined?
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 	Should the developer be required to establish an access plan?

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 	What is the scope of confidential information?
 	What are the obligations of the parties to protect confidential information?
 	Are there any exceptions to the confidentiality obligations?
 	Are the parties permitted to make public announcements related to the project?
 	Can the parties use each other’s name and logo for general marketing materials?

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                    [name] => Ensuring continuity
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                    [term_group] => 0
                    [term_taxonomy_id] => 281
                    [taxonomy] => issue
                    [description] => 
 	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?

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                    [count] => 55
                    [filter] => raw
                    [parent_name] => Equitable access
                    [parent_slug] => access-to-medicines
                )

            [access-to-medicines] => WP_Term Object
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                    [name] => Equitable access
                    [slug] => access-to-medicines
                    [term_group] => 0
                    [term_taxonomy_id] => 46
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 0
                    [count] => 0
                    [filter] => raw
                    [parent_name] => 
                    [parent_slug] => 
                )

            [roles-responsibilities] => WP_Term Object
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                    [name] => Governance
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                    [term_group] => 0
                    [term_taxonomy_id] => 278
                    [taxonomy] => issue
                    [description] => 
 	Do the parties govern the project through a joint steering committee ("JSC")? If so, what are the parties expressly designated roles and responsibilities with respect to the JSC?
 	Are there other committees, important governance bodies, or designated individual positions? What are the parties' roles and responsibilities with respect to them?
 	Are the parties required to meet in accordance with a defined schedule for decision-making and progress reporting activities?
 	What are the resolution mechanisms for disputes related to the agreement?
 	Are there any requirements for policies or procedures to manage potential conflicts of interest?

                    [parent] => 53
                    [count] => 87
                    [filter] => raw
                    [parent_name] => Business model
                    [parent_slug] => business-model
                )

            [indemnity] => WP_Term Object
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                    [term_id] => 80
                    [name] => Indemnification & liability
                    [slug] => indemnity
                    [term_group] => 0
                    [term_taxonomy_id] => 80
                    [taxonomy] => issue
                    [description] => 
 	What occurrences could result in a liability claim against which one party will indemnify the other?
 	Are there any circumstances under which one party will not indemnify the other?
 	What is the process for managing liability claims?
 	Are there government or other types of indemnification schemes?
 	Is there any limitation or monetary cap on each party’s liabilities under the agreement?

                    [parent] => 50
                    [count] => 99
                    [filter] => raw
                    [parent_name] => Liability
                    [parent_slug] => liability
                )

            [information-sharing-information-sharing] => WP_Term Object
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                    [term_id] => 257
                    [name] => Information sharing
                    [slug] => information-sharing-information-sharing
                    [term_group] => 0
                    [term_taxonomy_id] => 257
                    [taxonomy] => issue
                    [description] => 
 	What financial and project progress information must be shared between the parties?
 	What is the required timeline for sharing information?
 	How is the receiving party permitted to use the information received?
 	Do the parties have the right to verify the information reported?

                    [parent] => 49
                    [count] => 92
                    [filter] => raw
                    [parent_name] => Protecting & sharing information
                    [parent_slug] => information-sharing
                )

            [insurance] => WP_Term Object
                (
                    [term_id] => 109
                    [name] => Insurance
                    [slug] => insurance
                    [term_group] => 0
                    [term_taxonomy_id] => 109
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 50
                    [count] => 62
                    [filter] => raw
                    [parent_name] => Liability
                    [parent_slug] => liability
                )

            [ip-ownership] => WP_Term Object
                (
                    [term_id] => 48
                    [name] => Intellectual property
                    [slug] => ip-ownership
                    [term_group] => 0
                    [term_taxonomy_id] => 48
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 0
                    [count] => 0
                    [filter] => raw
                    [parent_name] => 
                    [parent_slug] => 
                )

            [liability] => WP_Term Object
                (
                    [term_id] => 50
                    [name] => Liability
                    [slug] => liability
                    [term_group] => 0
                    [term_taxonomy_id] => 50
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 0
                    [count] => 0
                    [filter] => raw
                    [parent_name] => 
                    [parent_slug] => 
                )

            [license-grants] => WP_Term Object
                (
                    [term_id] => 88
                    [name] => License grants
                    [slug] => license-grants
                    [term_group] => 0
                    [term_taxonomy_id] => 88
                    [taxonomy] => issue
                    [description] => 
 	Are any licenses granted for the use of background or foreground intellectual property?
 	What is the scope of the licensed intellectual property?
 	What is the territory of the license?
 	Is the license exclusive or non-exclusive?
 	Are there any restrictions on the use of the licensed intellectual property?
 	Are there any specific obligations to exploit the licensed intellectual property?
 	Can the licensee grant sublicenses to third parties?
 	Will products manufactured under license be marketed as branded or generic? (i.e. will they bear the licensor’s trademarks/trade dress)

                    [parent] => 48
                    [count] => 96
                    [filter] => raw
                    [parent_name] => Intellectual property
                    [parent_slug] => ip-ownership
                )

            [ownership-ip] => WP_Term Object
                (
                    [term_id] => 87
                    [name] => Ownership of IP
                    [slug] => ownership-ip
                    [term_group] => 0
                    [term_taxonomy_id] => 87
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 48
                    [count] => 71
                    [filter] => raw
                    [parent_name] => Intellectual property
                    [parent_slug] => ip-ownership
                )

            [royalties-and-payments] => WP_Term Object
                (
                    [term_id] => 70
                    [name] => Payment structures
                    [slug] => royalties-and-payments
                    [term_group] => 0
                    [term_taxonomy_id] => 70
                    [taxonomy] => issue
                    [description] => What is the payment structure under this agreement? 
What are the mechanisms to limit exposure to additional payments or expenses?
                    [parent] => 53
                    [count] => 79
                    [filter] => raw
                    [parent_name] => Business model
                    [parent_slug] => business-model
                )

            [outbreak-preparedness] => WP_Term Object
                (
                    [term_id] => 102
                    [name] => Preparedness & response
                    [slug] => outbreak-preparedness
                    [term_group] => 0
                    [term_taxonomy_id] => 102
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 46
                    [count] => 13
                    [filter] => raw
                    [parent_name] => Equitable access
                    [parent_slug] => access-to-medicines
                )

            [supply-purchase-of-products] => WP_Term Object
                (
                    [term_id] => 268
                    [name] => Product supply
                    [slug] => supply-purchase-of-products
                    [term_group] => 0
                    [term_taxonomy_id] => 268
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 53
                    [count] => 43
                    [filter] => raw
                    [parent_name] => Business model
                    [parent_slug] => business-model
                )

            [information-sharing] => WP_Term Object
                (
                    [term_id] => 49
                    [name] => Protecting & sharing information
                    [slug] => information-sharing
                    [term_group] => 0
                    [term_taxonomy_id] => 49
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 0
                    [count] => 0
                    [filter] => raw
                    [parent_name] => 
                    [parent_slug] => 
                )

            [protection-results] => WP_Term Object
                (
                    [term_id] => 90
                    [name] => Protection of IP
                    [slug] => protection-results
                    [term_group] => 0
                    [term_taxonomy_id] => 90
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 48
                    [count] => 70
                    [filter] => raw
                    [parent_name] => Intellectual property
                    [parent_slug] => ip-ownership
                )

            [publication-of-results] => WP_Term Object
                (
                    [term_id] => 290
                    [name] => Publication of results
                    [slug] => publication-of-results
                    [term_group] => 0
                    [term_taxonomy_id] => 290
                    [taxonomy] => issue
                    [description] => What information are the parties required or permitted to publish?
What is the required timeline for making data available?
What are the acceptable publication channels?
Is compliance with a specific open access policy required?
                    [parent] => 49
                    [count] => 61
                    [filter] => raw
                    [parent_name] => Protecting & sharing information
                    [parent_slug] => information-sharing
                )

            [quality-management] => WP_Term Object
                (
                    [term_id] => 372
                    [name] => Quality management
                    [slug] => quality-management
                    [term_group] => 0
                    [term_taxonomy_id] => 372
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 53
                    [count] => 36
                    [filter] => raw
                    [parent_name] => Business model
                    [parent_slug] => business-model
                )

            [regulatory-strategy] => WP_Term Object
                (
                    [term_id] => 56
                    [name] => Regulatory strategy
                    [slug] => regulatory-strategy
                    [term_group] => 0
                    [term_taxonomy_id] => 56
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 53
                    [count] => 53
                    [filter] => raw
                    [parent_name] => Business model
                    [parent_slug] => business-model
                )

            [warranties] => WP_Term Object
                (
                    [term_id] => 81
                    [name] => Representations & warranties
                    [slug] => warranties
                    [term_group] => 0
                    [term_taxonomy_id] => 81
                    [taxonomy] => issue
                    [description] => Should the parties make any warranties, and if so, what is the scope?
                    [parent] => 50
                    [count] => 88
                    [filter] => raw
                    [parent_name] => Liability
                    [parent_slug] => liability
                )

            [technology-transfer] => WP_Term Object
                (
                    [term_id] => 86
                    [name] => Technology transfer
                    [slug] => technology-transfer
                    [term_group] => 0
                    [term_taxonomy_id] => 86
                    [taxonomy] => issue
                    [description] => What is included in the technology and/or materials to be transferred?
What are the responsibilities of each party to in relation to the transfer of materials and/or technology?
                    [parent] => 49
                    [count] => 41
                    [filter] => raw
                    [parent_name] => Protecting & sharing information
                    [parent_slug] => information-sharing
                )

            [term-and-termination] => WP_Term Object
                (
                    [term_id] => 52
                    [name] => Term & termination
                    [slug] => term-and-termination
                    [term_group] => 0
                    [term_taxonomy_id] => 52
                    [taxonomy] => issue
                    [description] => Term

 	What is the term of the agreement? Is it tied to the timeline of the project or license grants?

Termination

 	Under what circumstances may a party terminate or withdraw from the agreement?

Effects of Termination

 	What are the effects of termination or withdrawal by a party?

                    [parent] => 0
                    [count] => 0
                    [filter] => raw
                    [parent_name] => 
                    [parent_slug] => 
                )

            [term-of-agreement] => WP_Term Object
                (
                    [term_id] => 76
                    [name] => Term of agreement
                    [slug] => term-of-agreement
                    [term_group] => 0
                    [term_taxonomy_id] => 76
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 52
                    [count] => 87
                    [filter] => raw
                    [parent_name] => Term & termination
                    [parent_slug] => term-and-termination
                )

            [termination-and-withdrawal] => WP_Term Object
                (
                    [term_id] => 74
                    [name] => Termination & withdrawal
                    [slug] => termination-and-withdrawal
                    [term_group] => 0
                    [term_taxonomy_id] => 74
                    [taxonomy] => issue
                    [description] => 
                    [parent] => 52
                    [count] => 91
                    [filter] => raw
                    [parent_name] => Term & termination
                    [parent_slug] => term-and-termination
                )

            [territory-access-commitments] => WP_Term Object
                (
                    [term_id] => 282
                    [name] => Territory access commitments
                    [slug] => territory-access-commitments
                    [term_group] => 0
                    [term_taxonomy_id] => 282
                    [taxonomy] => issue
                    [description] => 
 	How should ‘territory’ be defined under the agreement? Should the definition make a distinction between different types of purchaser (e.g. public sector vs. private sector)?
 	Should the developer be required to apply for regulatory approval in priority access markets?
 	Should the developer be required to commit a proportion of the product manufactured to a certain country or purchasing organization?
 	Should the developer be required to identify a third party that could fulfill supply requirements for the access territories in the event that the developer does not?
 	Should the agreement include any anti-diversion provisions?

                    [parent] => 46
                    [count] => 58
                    [filter] => raw
                    [parent_name] => Equitable access
                    [parent_slug] => access-to-medicines
                )

        )

    [filter_issues:GHIAA2019\MapguideSearch:private] => Array
        (
        )

)