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- Business model | Regulatory strategy
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Agreement title
Effective date
Partner type
Technology
Development stage
UK Secretary of State - Roche, REGN-COV2 Supply Agreement
2021
Government
Industry
Industry
Drug
Late clinical (Phase 3)
Commercialization
Commercialization
NIH - Fluidigm, COVID-19 Diagnostic Development Agreement
2020
Government
Industry
Industry
Diagnostic
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Late clinical (Phase 3)
Commercialization
Adjuvant Global Health Technology Fund - AN2 Therapeutics, Melioidosis & Tuberculosis Therapeutic (Epetraborole) Global Health Agreement
2021
Funder
Industry
Industry
Drug
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
European Commission - CureVac, COVID-19 Vaccine Advance Purchase Agreement
2020
Government
Industry
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
European Commission - AstraZeneca, COVID-19 Vaccine Advance Purchase Agreement
2020
Government
Industry
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
UK Secretary of State - AstraZeneca, COVID-19 Vaccine Supply Agreement
2020
Government
Industry
Industry
Vaccine
Commercialization
Atreca - Gates Medical Research Institute, Malaria Monoclonal Antibodies License Agreement
2021
Industry
Non-profit research organization
Non-profit research organization
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Late clinical (Phase 3)
Commercialization
US Department of Defense - Moderna, COVID-19 Vaccine Supply Agreement
2020
Government
Industry
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Early clinical (through Phase 2)
Late clinical (Phase 3)
Biological E - Dynavax Technologies, COVID-19 Vaccine Adjuvant Supply Agreement
2021
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
CARB-X Portfolio Company Agreement Template
2019
Academic institution
Funder
Industry
Non-profit research organization
Product development partnership
Funder
Industry
Non-profit research organization
Product development partnership
Diagnostic
Drug
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Preclinical
Early clinical (through Phase 2)
CEPI CfP3i Vaccine Funding Agreement Template
2018
Funder
Industry
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Early clinical (through Phase 2)
CEPI - CureVac, Framework Partnering Agreement
2019
Funder
Industry
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
CEPI - Dynavax, COVID-19 Material Reservation Agreement
2021
Funder
Industry
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Late clinical (Phase 3)
Commercialization
CEPI - University of Oxford - Barinthus Biotherapeutics, ChAdOx1 MERS Vaccine R&D Funding Agreement
2023
Academic institution
Funder
Industry
Funder
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
CEPI - Valneva, Chikungunya Vaccine Funding Agreement
2019
Funder
Industry
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Early clinical (through Phase 2)
CEPI - VBI, COVID-19 Vaccine Development Funding Agreement
2021
Funder
Industry
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Early clinical (through Phase 2)
CureVac - GSK, COVID-19 Vaccine Collaboration and License Agreement
2021
Industry
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
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
Industry
Non-profit research organization
Product development partnership
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Late clinical (Phase 3)
DNDi - BioDelivery Sciences International, Visceral Leishmaniasis Research Collaboration Agreement
2009
Industry
Product development partnership
Product development partnership
Drug
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
DNDi/GARDP - Entasis, Gonorrhoea Medication, Collaboration Agreement
2017
Industry
Product development partnership
Product development partnership
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Late clinical (Phase 3)
Commercialization
FIND Sample Funding Terms and Conditions
2021
Academic institution
Industry
Product development partnership
Industry
Product development partnership
Diagnostic
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Fiocruz - AstraZeneca, COVID-19 Technological Order Agreement
2021
Government
Industry
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
Fiocruz - AstraZeneca, COVID-19 Vaccine Technology Transfer Agreement
2021
Government
Industry
Industry
Vaccine
Commercialization
Funder Development Partnering Agreement Template
2018
Funder
Industry
Non-profit research organization
Product development partnership
Industry
Non-profit research organization
Product development partnership
Device
Diagnostic
Drug
Vaccine
Diagnostic
Drug
Vaccine
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
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
Industry
Drug
Commercialization
Gavi Alliance - Novavax, COVID-19 Vaccine Advance Purchase Agreement
2021
Industry
Multilateral organization
Multilateral organization
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
Gilead, HIV Therapeutic (Lenacapavir) Template License Agreement
2024
Industry
Drug
Late clinical (Phase 3)
Commercialization
Commercialization
MedinCell - MPP, Malaria Vector Control (mdc-STM/ivermectin formulation) License Agreement
2022
Industry
Multilateral organization
Multilateral organization
Drug
Late clinical (Phase 3)
Commercialization
Commercialization
Moderna – Lonza, COVID-19 mRNA Vaccine & Therapies, Manufacturing & Process Development Agreement
2020
Industry
Drug
Vaccine
Vaccine
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
AbbVie – MPP, HIV Antiretroviral (lopinavir, ritonavir - LPV/r) License Agreement
2016
Industry
Multilateral organization
Multilateral organization
Drug
Commercialization
AbbVie - MPP, HIV Antiretroviral (lopinavir, ritonavir - LPV/r) Pediatric License Agreement
2014
Industry
Multilateral organization
Multilateral organization
Drug
Commercialization
BMS - MPP, Hepatitis C Antiviral (daclatasvir - DAC) License & Tech Transfer Agreement
2016
Industry
Multilateral organization
Multilateral organization
Drug
Commercialization
BMS - MPP, HIV Antiretroviral (atazanavir - ATV) License and Technology Transfer Agreement
2017
Industry
Multilateral organization
Multilateral organization
Drug
Commercialization
Medigen - MPP (C-TAP), COVID-19 Vaccine, Patent and Know How License Agreement
2023
Industry
Multilateral organization
Multilateral organization
Vaccine
Commercialization
Gilead - MPP - Arene Lifesciences, HIV Therapeutic License Agreement
2018
Industry
Multilateral organization
Multilateral organization
Drug
Commercialization
University of Liverpool – MPP, HIV Therapeutic Collaboration Agreement and Patent & Know-How License
2015
Academic institution
Multilateral organization
Multilateral organization
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Merck - MPP, Molnupiravir License Agreement
2021
Industry
Multilateral organization
Multilateral organization
Drug
Late clinical (Phase 3)
Commercialization
Commercialization
US Department of Defense - Ology Bioservices, COVID-19 Plasmid Procurement Agreement
2020
Government
Industry
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Late clinical (Phase 3)
Commercialization
Novartis – MPP, Nilotinib, Non-Exclusive License Agreement
2022
Industry
Multilateral organization
Multilateral organization
Drug
Commercialization
CEPI - Novavax, COVID-19 Vaccine Funding Agreement
2020
Funder
Industry
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
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
Ocugen-BBIL, COVID-19 Vaccine (Covaxin), Co-development, Supply & Commercialization Agreement
2021
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
Dominican Republic Ministry of Health - Pfizer/BioNTech, COVID-19 Vaccine Binding Term Sheet
2021
Government
Industry
Industry
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
Population Council - TherapeuticsMD, Nestorone Contraceptive Ring, License Agreement
2018
Industry
Non-profit research organization
Non-profit research organization
Device
Commercialization
Field Testing
Field Testing
US Department of Defense – Regeneron, COVID-19 Antibodies Large-Scale Manufacturing Agreement
2020
Government
Industry
Industry
Drug
Late clinical (Phase 3)
Commercialization
Commercialization
Roche - PTC Therapeutics - Spinal Muscular Atrophy Foundation, SMA Therapeutic License and Collaboration Agreement
2011
Funder
Industry
Non-profit research organization
Industry
Non-profit research organization
Drug
Late clinical (Phase 3)
Commercialization
Commercialization
US Department of Defense - Sanofi, COVID-19 Vaccine Development Agreement
2020
Government
Industry
Industry
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Field Testing
Late clinical (Phase 3)
Commercialization
Field Testing
Shionogi - GARDP, Cefiderocol License Agreement
2022
Industry
Product development partnership
Product development partnership
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Late clinical (Phase 3)
Commercialization
Spinal Muscular Atrophy Foundation - PTC Therapeutics, Spinal Muscular Atrophy Therapeutics Sponsored Research Agreement
2006
Industry
Non-profit research organization
Non-profit research organization
Drug
Discovery/Concept
Preclinical
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
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
Industry
Device
Vaccine
Vaccine
Early clinical (through Phase 2)
Late clinical (Phase 3)
Late clinical (Phase 3)
UK Medical Research Council - Indevus Pharmaceuticals, Antiviral Microbicide, Collaborative Research and Licensing Agreement
2005
Government
Industry
Industry
Drug
Late clinical (Phase 3)
University of Washington - MPP, Long-acting Injectable HIV Treatment License Agreement
2021
Academic institution
Multilateral organization
Multilateral organization
Drug
Preclinical
US Department of Defense - Janssen, COVID-19 Vaccine Large Scale Manufacturing Agreement
2020
Government
Industry
Industry
Vaccine
Commercialization
ViiV - MPP, HIV Prevention Medicine (Cabotegravir LA for PrEP), License Agreement
2022
Industry
Multilateral organization
Multilateral organization
Drug
Late clinical (Phase 3)
Commercialization
Commercialization
Visterra - Serum Institute of India, Dengue Fever Therapeutic, License and Collaboration Agreement
2015
Industry
Drug
Early clinical (through Phase 2)
Late clinical (Phase 3)
Commercialization
Late clinical (Phase 3)
Commercialization
Wellcome Trust - PTC Therapeutics, Cancer Treatment Research Funding Agreement
2010
Funder
Industry
Industry
Drug
Discovery/Concept
Preclinical
Preclinical
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Should the developer be required to comply with an equitable access policy?
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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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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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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?
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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?
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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?
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)
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[description] => What is the payment structure under this agreement?
What are the mechanisms to limit exposure to additional payments or expenses?
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What are the acceptable publication channels?
Is compliance with a specific open access policy required?
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What are the responsibilities of each party to in relation to the transfer of materials and/or technology?
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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?
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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?
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[count] => 63
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[parent_slug] => access-to-medicines
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How should equitable or global access be defined?
Should the developer be required to comply with an equitable access policy?
Should the developer be required to establish an access plan?
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[parent] => 46
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[description] =>
[parent] => 53
[count] => 16
[filter] => raw
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[parent] => 53
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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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[donation] => WP_Term Object
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[parent] => 46
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[parent_name] => Equitable access
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[taxonomy] => issue
[description] =>
[parent] => 52
[count] => 96
[filter] => raw
[parent_name] => Term & termination
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[ensuring-continuity] => WP_Term Object
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[taxonomy] => issue
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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?
[parent] => 46
[count] => 55
[filter] => raw
[parent_name] => Equitable access
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[access-to-medicines] => WP_Term Object
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[description] =>
[parent] => 0
[count] => 0
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[roles-responsibilities] => WP_Term Object
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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?
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[count] => 98
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[parent_name] => Business model
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[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] => 110
[filter] => raw
[parent_name] => Liability
[parent_slug] => liability
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[information-sharing-information-sharing] => WP_Term Object
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[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] => 102
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[parent_name] => Protecting & sharing information
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[insurance] => WP_Term Object
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[description] =>
[parent] => 50
[count] => 69
[filter] => raw
[parent_name] => Liability
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[ip-ownership] => WP_Term Object
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[taxonomy] => issue
[description] =>
[parent] => 0
[count] => 0
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[liability] => WP_Term Object
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[taxonomy] => issue
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[parent] => 0
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[parent_name] =>
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[license-grants] => WP_Term Object
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[name] => License grants
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[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] => 107
[filter] => raw
[parent_name] => Intellectual property
[parent_slug] => ip-ownership
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[ownership-ip] => WP_Term Object
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[term_id] => 87
[name] => Ownership of IP
[slug] => ownership-ip
[term_group] => 0
[term_taxonomy_id] => 87
[taxonomy] => issue
[description] =>
[parent] => 48
[count] => 80
[filter] => raw
[parent_name] => Intellectual property
[parent_slug] => ip-ownership
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[royalties-and-payments] => WP_Term Object
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[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] => 90
[filter] => raw
[parent_name] => Business model
[parent_slug] => business-model
)
[outbreak-preparedness] => WP_Term Object
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[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
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[supply-purchase-of-products] => WP_Term Object
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[term_id] => 268
[name] => Product supply
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[taxonomy] => issue
[description] =>
[parent] => 53
[count] => 45
[filter] => raw
[parent_name] => Business model
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[information-sharing] => WP_Term Object
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[taxonomy] => issue
[description] =>
[parent] => 0
[count] => 0
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[parent_name] =>
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[protection-results] => WP_Term Object
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[name] => Protection of IP
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[taxonomy] => issue
[description] =>
[parent] => 48
[count] => 82
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[parent_name] => Intellectual property
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[publication-of-results] => WP_Term Object
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[name] => Publication of results
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[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] => 67
[filter] => raw
[parent_name] => Protecting & sharing information
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[quality-management] => WP_Term Object
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[name] => Quality management
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[taxonomy] => issue
[description] =>
[parent] => 53
[count] => 41
[filter] => raw
[parent_name] => Business model
[parent_slug] => business-model
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[regulatory-strategy] => WP_Term Object
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[term_id] => 56
[name] => Regulatory strategy
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[taxonomy] => issue
[description] =>
[parent] => 53
[count] => 57
[filter] => raw
[parent_name] => Business model
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[warranties] => WP_Term Object
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[term_id] => 81
[name] => Representations & warranties
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[term_taxonomy_id] => 81
[taxonomy] => issue
[description] => Should the parties make any warranties, and if so, what is the scope?
[parent] => 50
[count] => 98
[filter] => raw
[parent_name] => Liability
[parent_slug] => liability
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[technology-transfer] => WP_Term Object
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[name] => Technology transfer
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[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] => 45
[filter] => raw
[parent_name] => Protecting & sharing information
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[term-and-termination] => WP_Term Object
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[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] =>
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[term-of-agreement] => WP_Term Object
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[taxonomy] => issue
[description] =>
[parent] => 52
[count] => 98
[filter] => raw
[parent_name] => Term & termination
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[termination-and-withdrawal] => WP_Term Object
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[taxonomy] => issue
[description] =>
[parent] => 52
[count] => 102
[filter] => raw
[parent_name] => Term & termination
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[territory-access-commitments] => WP_Term Object
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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] => 63
[filter] => raw
[parent_name] => Equitable access
[parent_slug] => access-to-medicines
)
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[filter_issues:GHIAA2019\MapguideSearch:private] => Array
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