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- CEPI - Novavax, COVID-19 Vaccine Funding Agreement
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Agreement title
Effective date
Partner type
Technology
Development stage
Gavi Alliance - Novavax, COVID-19 Vaccine Advance Purchase Agreement
2021
Industry
Multilateral organization
Multilateral organization
Vaccine
Late clinical (Phase 3)
Commercialization
Commercialization
- Equitable access | Ensuring continuity
- Equitable access | Access plans & principles
- Equitable access | Preparedness & response
- Equitable access | Affordable pricing
- Equitable access | Territory access commitments
- Business model | Regulatory strategy
- Business model | Governance
- Business model | Payment structures
- Business model | Product supply
- Protecting & sharing information | Confidentiality
- Protecting & sharing information | Information sharing
- Intellectual property | License grants
- Intellectual property | Ownership of IP
- Liability | Indemnification & liability
- Liability | Insurance
- Liability | Representations & warranties
- Term & termination | Effects of termination
- Term & termination | Term of agreement
- Term & termination | Termination & withdrawal
CEPI - Novavax, COVID-19 Vaccine Funding Agreement
2020
Funder
Industry
Industry
Vaccine
Commercialization
- Equitable access | Ensuring continuity
- Equitable access | Access plans & principles
- Equitable access | Preparedness & response
- Equitable access | Affordable pricing
- Equitable access | Territory access commitments
- Business model | Benefit sharing
- Business model | Clinical trial conduct
- Business model | Quality management
- Business model | Regulatory strategy
- Business model | Governance
- Business model | Payment structures
- Business model | Product supply
- Protecting & sharing information | Confidentiality
- Protecting & sharing information | Information sharing
- Protecting & sharing information | Publication of results
- Intellectual property | License grants
- Intellectual property | Ownership of IP
- Intellectual property | Protection of IP
- Liability | Indemnification & liability
- Liability | Insurance
- Liability | Representations & warranties
- Term & termination | Effects of termination
- Term & termination | Term of agreement
- Term & termination | Termination & withdrawal
Novavax - Serum Institute of India, COVID-19 Vaccine Supply and License Agreement
2020
Industry
Vaccine
Commercialization
- Equitable access | Ensuring continuity
- Equitable access | Territory access commitments
- Business model | Quality management
- Business model | Regulatory strategy
- Business model | Governance
- Business model | Payment structures
- Business model | Product supply
- Protecting & sharing information | Confidentiality
- Protecting & sharing information | Information sharing
- Protecting & sharing information | Technology transfer
- Intellectual property | License grants
- Intellectual property | Ownership of IP
- Intellectual property | Protection of IP
- Liability | Indemnification & liability
- Liability | Insurance
- Liability | Representations & warranties
- Term & termination | Effects of termination
- Term & termination | Term of agreement
- Term & termination | Termination & withdrawal
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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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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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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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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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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?
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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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[taxonomy] => issue
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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)
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[filter] => raw
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[taxonomy] => issue
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[parent] => 48
[count] => 65
[filter] => raw
[parent_name] => Intellectual property
[parent_slug] => ip-ownership
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[name] => Payment structures
[slug] => royalties-and-payments
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[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] => 75
[filter] => raw
[parent_name] => Business model
[parent_slug] => business-model
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[102] => WP_Term Object
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[name] => Preparedness & response
[slug] => outbreak-preparedness
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[taxonomy] => issue
[description] =>
[parent] => 46
[count] => 12
[filter] => raw
[parent_name] => Equitable access
[parent_slug] => access-to-medicines
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[268] => WP_Term Object
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[name] => Product supply
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[taxonomy] => issue
[description] =>
[parent] => 53
[count] => 40
[filter] => raw
[parent_name] => Business model
[parent_slug] => business-model
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[name] => Protecting & sharing information
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[taxonomy] => issue
[description] =>
[parent] => 0
[count] => 0
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[90] => WP_Term Object
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[name] => Protection of IP
[slug] => protection-results
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[taxonomy] => issue
[description] =>
[parent] => 48
[count] => 64
[filter] => raw
[parent_name] => Intellectual property
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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?
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[count] => 55
[filter] => raw
[parent_name] => Protecting & sharing information
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[description] =>
[parent] => 53
[count] => 33
[filter] => raw
[parent_name] => Business model
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[name] => Regulatory strategy
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[taxonomy] => issue
[description] =>
[parent] => 53
[count] => 49
[filter] => raw
[parent_name] => Business model
[parent_slug] => business-model
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[name] => Representations & warranties
[slug] => warranties
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[taxonomy] => issue
[description] => Should the parties make any warranties, and if so, what is the scope?
[parent] => 50
[count] => 80
[filter] => raw
[parent_name] => Liability
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[86] => WP_Term Object
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[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] => 36
[filter] => raw
[parent_name] => Protecting & sharing information
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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?
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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] => 52
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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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[count] => 13
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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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[parent] => 46
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[parent_name] => Equitable access
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[taxonomy] => issue
[description] =>
[parent] => 52
[count] => 77
[filter] => raw
[parent_name] => Term & termination
[parent_slug] => term-and-termination
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[ensuring-continuity] => WP_Term Object
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[term_id] => 281
[name] => Ensuring continuity
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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?
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[count] => 53
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[parent_name] => Equitable access
[parent_slug] => access-to-medicines
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[access-to-medicines] => WP_Term Object
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[roles-responsibilities] => WP_Term Object
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[name] => Governance
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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] => 79
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[parent_name] => Business model
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[indemnity] => WP_Term Object
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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] => 93
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[parent_name] => Liability
[parent_slug] => liability
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[information-sharing-information-sharing] => WP_Term Object
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[name] => Information sharing
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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?
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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] => 55
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[parent_name] => Liability
[parent_slug] => liability
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[ip-ownership] => WP_Term Object
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[term_id] => 48
[name] => Intellectual property
[slug] => ip-ownership
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[liability] => WP_Term Object
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[license-grants] => WP_Term Object
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[name] => License grants
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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] => 89
[filter] => raw
[parent_name] => Intellectual property
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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] => 65
[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] => 75
[filter] => raw
[parent_name] => Business model
[parent_slug] => business-model
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[outbreak-preparedness] => WP_Term Object
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[term_id] => 102
[name] => Preparedness & response
[slug] => outbreak-preparedness
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[term_taxonomy_id] => 102
[taxonomy] => issue
[description] =>
[parent] => 46
[count] => 12
[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
[slug] => supply-purchase-of-products
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[description] =>
[parent] => 53
[count] => 40
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[parent_name] => Business model
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[information-sharing] => WP_Term Object
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[parent] => 0
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[protection-results] => WP_Term Object
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[term_id] => 90
[name] => Protection of IP
[slug] => protection-results
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[description] =>
[parent] => 48
[count] => 64
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[parent_name] => Intellectual property
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[publication-of-results] => WP_Term Object
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[term_id] => 290
[name] => Publication of results
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[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?
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[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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[description] =>
[parent] => 53
[count] => 33
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[parent_name] => Business model
[parent_slug] => business-model
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[regulatory-strategy] => WP_Term Object
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[name] => Regulatory strategy
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[parent] => 53
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[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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[taxonomy] => issue
[description] => Should the parties make any warranties, and if so, what is the scope?
[parent] => 50
[count] => 80
[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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[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?
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[count] => 36
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[parent_name] => Protecting & sharing information
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[term-and-termination] => WP_Term Object
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[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?
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[term-of-agreement] => WP_Term Object
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[parent_name] => Term & termination
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[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?
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[count] => 52
[filter] => raw
[parent_name] => Equitable access
[parent_slug] => access-to-medicines
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(
)
)