Wednesday, 2 December 2020

COVAX VACCINE REQUEST:

GAVI GRANT TERMS AND CONDITIONS FOR COVAX AMC GROUP
PARTICIPANTS
 
Please note that this Application has been split out into two sections: Part A which must be submitted by
7 December 2020; and Part B which must be submitted by 14 December 2020. Please note that submission of a
completed Part A is required for confirmation of participation to COVAX and Part B is needed to complete the
application.

For Countries that have an agreed Partnership Framework Agreement (PFA) with Gavi, the terms and conditions
of the PFA remain in full effect and shall apply to any and all Gavi support made pursuant to this Application.
The Gavi Grant Terms and Conditions set out below shall also apply to the Approved Vaccines, equipment, and
supplies made available through COVAX. In the event of any conflict between any term, condition, or provision
of the PFA and any term, condition, or provision of this Application, the term, condition, or provision contained in
this Application shall prevail. For Countries where there is no agreed PFA between Gavi and the Country, the
terms and conditions of this Application shall apply to any and all Gavi support made pursuant to this
Application. By signing this Application, returning it to Gavi and accepting delivery of any Approved Vaccines or
related equipment or supplies, the Government of [ ] (the “Country”) acknowledges that the
supply of Approved Vaccines, equipment and supplies shall be subject to the following Gavi Grant Terms and
Conditions. 

In addition, for all countries, those with an agreed PFA with Gavi and those without an agreed PFA, the terms
and conditions set out in the COVAX Facility Terms and Conditions attached to Annex A of Part A to this
Application shall apply to any and all Gavi support made pursuant to this Application. By signing this Application,
returning it to Gavi and accepting delivery of any Approved Vaccine or related equipment or supplies, the
Country accepts and agrees that the supplies of Approved Vaccines and related equipment and supplies shall
also be subject to the terms of the COVAX Facility Terms and Conditions.

All terms capitalized but not otherwise defined shall have the meanings given to them in the COVAX Terms and
Conditions.

GAVI GRANT TERMS AND CONDITIONS 

FUNDING USED SOLELY FOR APPROVED PROGRAMMES
The Country confirms that all funding and Approved Vaccine provided by Gavi will be used and applied for the
sole purpose of fulfilling the programme(s) described in the Country's Application. Any significant change from
the approved programme(s) must be reviewed and approved in advance by Gavi. All funding decisions for the
Application are made at the discretion of Gavi and are subject to any review process as required by Gavi and/or
the COVAX Partners and the availability of funds. 
 
AMENDMENT TO THE APPLICATION
The Country will notify Gavi as part of its reporting mechanism if it wishes to propose any change to the
programme(s) description in its Application. Gavi will document any change approved by Gavi according to its
guidelines, and the Country's Application will be amended.  

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RETURN OF FUNDS
The Country agrees to reimburse to Gavi all funding amounts (i.e., any cash or the value of any equipment,
supplies or Approved Vaccine) that Gavi determines not to have been used for the programme(s) described in
its Application or otherwise misused. The Country's reimbursement must be in US dollars and be provided,
unless otherwise decided by Gavi, within sixty (60) days after the Country receives Gavi's request for a
reimbursement and be paid to the account or accounts as directed by Gavi. 
 
SUSPENSION/ TERMINATION 
Gavi may suspend all or part of its funding or Approved Vaccine allocation to the Country if it has reason to
suspect that funds, equipment, supplies or Approved Vaccine have been misused or used for purpose other than
for the programme(s) described in the Country’s Application, or any Gavi-approved amendment to the
Application. Gavi retains the right to terminate its support to the Country for the programme(s) described in its
Application if a misuse of Gavi funds, equipment, supplies or Approved Vaccine is confirmed.

UNDERTAKINGS OF THE PARTICIPANT

These undertakings shall remain in force from the date of signature of this Application for so long as any
obligation hereunder remains outstanding.
(a) The Country shall promptly obtain, comply with and do all that is necessary to maintain in full
force and effect any Authorisation required under any law or regulation to enable it to perform its
obligations under this Application.
(b) The Country represents and warrants to Gavi that:
(i) it has full power and authority to execute, perform and deliver this Application and the
transactions contemplated herein;
(ii) this Application has been duly authorised, executed and delivered by it and constitutes
valid and legally binding obligations of it and enforceable against it in accordance with its
terms;
(iii) all actions required to be taken (including the obtaining of any Authorisation) for the
execution of this Application, the carrying out of the other transactions contemplated herein, or
the compliance by it with the terms hereof, as the case may be, have been taken and any
Authorisations are in full force and effect;
(iv) its execution and delivery of this Application, the consummation of the transactions
herein contemplated and compliance with the terms hereof do not infringe any existing
applicable law, rule, regulation judgment, order or decree applicable to it or any international
treaty convention or agreement to which it is a part or by which it is bound; and
(c) The Country shall promptly notify Gavi in writing immediately on becoming aware of any breach
of any of the representations and warranties set out herein.

LIABILITY 
To the fullest extent permitted by law, neither Gavi, any other COVAX Partner, nor any Procurement Agency will
be liable to the Country, and the Country shall not bring a claim or action against Gavi, any other COVAX
Partner, nor any Procurement Agency for any claim or loss of whatever nature relating to the use or
administration of any Approved Vaccine or programme(s) described in the Application, including without
limitation, any financial loss, reliance claims, any harm to property, or personal injury or death. The Country is
solely responsible for all aspects of managing and implementing the programme(s) described in its Application.

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Neither Gavi, nor any donors to the COVAX AMC, any Procurement Agency, distributors, vaccinators nor other
stakeholders (including the other COVAX Partners) make any assessment, representation or warranty as to the
safety, efficacy or suitability of the Approved Vaccine which is allocated to the Country. On this basis, the
Country acknowledges that neither Gavi, nor any donors to the COVAX AMC, any Procurement Agency,
distributors, vaccinators nor other stakeholders (including the COVAX Partners) shall have any liability to the
Country or any third parties in respect of the use or administration of any Approved Vaccine provided pursuant to
this Application (including any claim relating to, or arising from, inadequate warnings regarding the Approved
Vaccine).

As between Gavi and the Country, the Country shall be solely responsible for any  liability that may arise in
connection with: (i) the implementation of any programme(s) in the Country; and (ii) the use, administration or
distribution of Approved Vaccines allocated and distributed to the Country, and related equipment and supplies
after title to such Approved Vaccines, equipment and supplies has passed to the Country.  In addition, the
Country shall be responsible for all claims and liabilities in accordance with the Indemnity Agreement to be
entered into between the Country and manufacturer with respect to Approved Vaccines allocated and distributed
to the Country.

INDEMNIFICATION
The Country agrees to indemnify and hold harmless Gavi, any donors to the COVAX AMC any other COVAX
Partner, any Procurement Agency, distributors, vaccinators or other stakeholders against any claims and
liabilities, including legal fees and costs, which may be made, filed or assessed against Gavi any donors to the
COVAX AMC, and other COVAX Partner, any Procurement Agency, distributors, vaccinators or other
stakeholders on account of any bodily injury, illness, suffering, disease or death caused by the use or
administration of the Approved Vaccine, equipment or supplies in the Country.

NO REPLACEMENT OF DEFECTIVE PRODUCT

Neither Gavi, any Procurement Agency, distributors, vaccinators or other stakeholders (including the COVAX
Partners) shall be responsible for any defect in Approved Vaccines and related supplies. Neither Gavi, any
Procurement Agency, distributors, vaccinators or other stakeholders (including the COVAX Partners) shall be
responsible for providing any additional funding to replace any Approved Vaccines and related equipment or
supplies that are, or became, defective or disqualified for whatever reason. 

FAILURE TO SUPPLY
Neither Gavi, any Procurement Agency, distributors, vaccinators or other stakeholders (including the COVAX
Partners) will be liable or held responsible for any delay or failure in the supply of any Approved Vaccine or
related equipment or supplies as a result of force majeure or act by government or other authorities that may
prevent or restrict the delivery of the Approved Vaccine, equipment or supplies or that may preclude or restrict
the free movement of the Approved Vaccine, equipment or supplies to the agreed site of delivery.

NO EXPORTATION
The doses of Approved Vaccines made available pursuant to this Application shall not be exported or otherwise
made available for use outside the Country.

NO RESALE
The doses of Approved Vaccine, equipment and supplies supplied pursuant to this Application will not be sold
but will only be provided to the targeted population in the Country free of charge or at nominal cost to recuperate
reasonable expenses incurred in connection with delivery to the targeted population.

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INSURANCE 
Unless otherwise agreed with Gavi, the Country shall maintain, where available at a reasonable cost, all risk
property insurance on the programme assets (including Approved Vaccines and related equipment and supplies)
with financially sound and reputable insurance companies. The insurance coverage will be consistent with that
held by similar entities engaged in comparable activities. In any case, the Country will be solely responsible for
the replacement of any damaged or missing Approved Vaccines, equipment and/or related supplies.
 
ANTI-CORRUPTION 
The Country confirms that if any funding or Approved Vaccine is provided by Gavi for the programme, such
funds or doses of Approved Vaccine shall not be offered by the Country to any third person for the purposes of
receiving any benefit directly or indirectly, nor will the Country seek in connection with its Application any gift,
payment or benefit directly or indirectly that could be construed as an illegal or corrupt practice.  
 
ANTI-TERRORISM AND MONEY LAUNDERING 
The Country confirms that if any funding is provided by Gavi for the programme, such funds shall not be used to
support or promote violence, war or the suppression of the general populace of any country, aid terrorists or their
activities, conduct money laundering or fund organisations or individuals associated with terrorism or that are
involved in money-laundering activities, or to pay or import goods, if such payment or import, to the Country’s
knowledge or belief, is prohibited by the United Nations Security Council. 
 
AUDITS AND RECORDS 
If any funding is provided by Gavi for the programme, the Country will conduct an annual financial audit of the
Gavi grant funds and share the audit report(s) from such audit with Gavi, as requested within six months of the
close of each financial year. The Country shall also share any audits or assessments carried out on the use of
Approved Vaccine, equipment and supplies. Gavi reserves the right, on its own or through an agent, to perform
audits or other assessments to ensure the accountability of funds, Approved Vaccine, equipment and supplies
disbursed to the Country. 
 
If any funding is provided by Gavi for the programme, the Country will maintain accurate accounting records
documenting how Gavi funds are used. The Country will maintain its accounting records in accordance with its
government-approved accounting standards for at least three years after the date of last disbursement of Gavi
funds. The country will maintain accurate records documenting how doses of Approved Vaccine, equipment and
supplies are managed and disbursed as relevant.
 
If there is any claim of misuse of funds, equipment, supplies or Approved Vaccine, Country will maintain such
records until the audit findings are final. The Country agrees not to assert any documentary privilege against
Gavi in connection with any audit. 
 
CONFIRMATION OF LEGAL VALIDITY 
The Country and the signatories for the Country confirm that its Application, or any other agreed annual
reporting mechanism, is accurate and correct and forms legally binding obligations on the Country, under the
Country's law, to perform the programme(s) described in its Application, as amended, if applicable.
 
COMPLIANCE WITH GAVI POLICIES 
The Country should familiarise itself with all Gavi policies, guidelines and processes relevant to the
programme(s), including without limitation the Transparency and Accountability Policy (TAP) and comply with
the requirements therein. All programme related policies, guidelines and processes are available on Gavi’s
official website and/or sent to the Country. 

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USE OF COMMERCIAL BANK ACCOUNTS 

The Country is responsible for undertaking the necessary due diligence on all commercial banks used to
manage Gavi cash-based support. The Country confirms that it will take all responsibility for replenishing Gavi
cash support lost due to bank insolvency, fraud or any other unforeseen event. 
 
LANGUAGE
The English language version of these Gavi Grant Application Terms and Conditions shall prevail if there is a
conflict between the English language version and a translated version.

ARBITRATION AND GOVERNING LAW

This Application and any non-contractual obligations arising out of or in connection with it shall be governed by
English law.

Any dispute, controversy or claim (“Dispute”) between the Country and Gavi arising out of or in connection with
this Application shall be submitted to arbitration at the request of either Gavi or the Country. The arbitration will
be conducted in accordance with the then-current rules of the United Nations Commission of International Trade
Law (UNCITRAL). Gavi and the Country shall each appoint one arbitrator, and the two arbitrators so appointed
shall jointly appoint a third arbitrator who shall be the chairperson. If either party fails to appoint an arbitrator, the
appointing authority shall instead be the President of the Swiss Arbitration Association. The arbitration
proceedings shall take place in Geneva (which is the seat of the arbitration) and shall be conducted in English.
The parties agree to be bound by any arbitration award, as the final adjudication of any such Dispute.
 
DEFINITIONS
For purposes of these Gavi Grant Terms and Conditions:

(a) “Application” means Part A and Part B of the application for vaccine support, cold
chain equipment (CCE) support, technical assistance (TA) or such other support that the Gavi Board
may offer from time to time to realise the objectives of the COVAX AMC;
(b) "Authorisation" means an authorisation, consent, approval, resolution, licence,
exemption, filing, notarisation or registration;
(c) “Country” means the Government of the country or territory of [ ].
(d) “COVAX Partner” means the Coalition for Epidemic Preparedness Innovations (CEPI),
Gavi and the World Health Organisation (WHO);
(e) “COVAX Terms and Conditions” means the COVAX Facility Terms and Conditions for
the AMC Group Participants attached to this Application at Annex A of Part A;
(f) “Procurement Agency” means the Pan American Health Organization (PAHO) and the
United Nations Children’s Fund (UNICEF).

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COVAX VACCINE REQUEST:

AMC GROUP PARTICIPANT NAME COVID-19 VACCINE REQUEST
FORM – PART A

Please email completed Vaccine Requests to [email protected] copying the relevant Gavi Senior
Country Manager or focal point (whichever is applicable) by December 7, 2020, to confirm participation in the
COVAX Facility. Please note that there is a Part B to the Application which will be provided separately. Your
Application will only be complete upon submission of both Part A and Part B of the Application. Contact your
Gavi Senior Country Manager or focal point (whichever is applicable) in case of questions. Note that economies
eligible for the COVAX AMC may request Technical Assistance to complete the Vaccine Request.

1. GENERAL INFORMATION
a. Date of the request (DD/MM/YYYY):      
b. AMC Group Participant Name:      
c. Requesting institution:      
Address:      
Contact name:      
Contact phone:      
Contact email:      

When submitting the Vaccine Request, please attach a list of members and contact information for your COVID-
19 Vaccine National Taskforce including relevant technical partners and donor financing institute(s). Please
include a focal point(s) for regulatory and safety preparedness, and indemnity.

2. TARGET POPULATION VACCINATION PLANNING

In choosing target populations for vaccination, AMC Group Participants are recommended to follow the WHO
SAGE roadmap for prioritizing uses of COVID-19 vaccines in the context of limited supply and WHO
SAGE values framework for the allocation and prioritization of COVID-19 vaccination, which can be found
here: https://www.who.int/immunization/sage/covid-19_documents/en/.

a. Planned date for the start of the vaccination (DD/MM/YYYY):      

b. In light of the WHO SAGE Roadmap (link above), what % of the total population is being targeted for
vaccination once supply allows? This number may be smaller or larger than 20%:      
c. In the table below, please list the groups being targeted for vaccination in order of priority:
Target population (description) Proportion of total population (%)
           
           
           

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d. Please enter a rationale for your target populations (e.g., aligns with WHO SAGE recommendations):
     
e. Please complete the questions below on injection devices (syringes) and safety boxes:
Total number of injection devices (syringes) available which could be used for COVID-19 vaccinations:      
Total number of safety boxes available which could be used for collection of injection devices for COVID-19
vaccinations:
     
If you anticipate a need for additional injection devices (syringes) and safety boxes to be used for COVID-19
vaccination, what procurement mechanism do you intend to use?
UNICEF☐ PAHO☐ Self-procurement ☐
For AMC Group Participants that ticked “UNICEF” or “PAHO” above, please provide the dry storage capacity
at the national/central level):
 Total dry storage capacity:      m3 net available
 Dry storage capacity available for injection devices (syringes) and safety boxes to be used for COVID-19
vaccination:      m3 net available

3. COST SHARING

The data on cost-sharing requested in this form is for information only and does not constitute a legally binding
commitment at this stage.

AMC Group Participants are requested to cost share against the doses received through the Facility. However,
an inability to cost share will not affect COVAX AMC Participants’ abilities to access the fully subsidized donor-
funded doses provided through the COVAX AMC. Cost sharing can be used to fund supplementary doses
beyond those funded by COVAX AMC donors, thus enabling AMC Group Participants to reach a greater share
of their populations. If the aspired target population for vaccination cannot be fully met through donor-funded
COVAX AMC doses, would you be interested in purchasing any additional doses through COVAX, fully financed
via cost-sharing contributions? (Non-binding; for information only)
Yes ☐ No ☐

4. DOMESTIC COVID-19 VACCINE PRODUCTION AND BILATERAL DEALS

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As noted in Annex A (COVAX Terms and Conditions) of this Part A, the COVAX Facility requests transparency
about bilateral deals, existing and future, from all participants, noting that access to doses from bilateral deals
will not impact access to the agreed volume of doses of Approved Vaccine from the COVAX Facility.

Provision of the below information will help to highlight where further discussions may be helpful, for example to
align on any logistical supply chain issues or to explore opportunities to partner for mutual benefit, i.e. fungibility
in complementary deals. It could, for example, enhance the understanding of whether there are circumstances
or constraints in your system due to other vaccines or planned campaigns that would affect your ability to
receive Approved Vaccines.

a. Do you have domestic COVID-19 vaccine production capacity? If yes, please complete the table below.
Yes☐ No ☐

Manufacture Vaccine Planned capacity Expected date of availability of

r type(s) (doses/time period) first doses (DD/MM/YYYY)
                       
                       
                       
                       
                       

b. Are there bilateral deals in place to purchase COVID-19 vaccines directly from manufacturers? If yes,
please complete the table below.
Yes ☐ No ☐

Manufacture Vaccine Volume agreed in Expected date of availability of

r type(s) doses first doses (DD/MM/YYYY)
                       
                       
                       
                       
                       

5. VACCINE CHARACTERISTICS
The Allocation Mechanism will endeavour to integrate product preference into vaccine allocations. While efforts
will be made to establish ‘best-matches’ between products and preferences, AMC Group Participants are not
guaranteed to receive products with preferred characteristics, given preference is one of many factors, including
limited supply availability, that need to be considered when allocating Approved Vaccine.

a. Please complete the table below.

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Please rank all 12 vaccine Example (This is purely

Vaccine characteristics (a to m) for illustration purposes
characteristic Vaccine characteristic from most desirable at the and is not meant to
grouping top least desirable at the influence AMC Group
bottom Participant preferences)
a. mRNA       l. Lower price
Vaccine b. Inactivated       k. Fewer doses per regimen
Platform d. Vaccines that have been
c. Viral Vector      
Prequalified by WHO
d. Vaccines that have g. Vaccines with traditional
been Prequalified by       cold chain requirements (2-
WHO 8°C)
e. Vaccines that have
received approval from a
Regulatory       b. Inactivated
Stringent Regulatory
process
Authority so far
e. Vaccines that have
f. Vaccines that have been
received approval from a
granted only Emergency      
Stringent Regulatory
Use Listing so far
Authority so far
g. Vaccines with
traditional cold chain       c. Viral Vector
requirements (2-8°C)
h. Vaccines with
Cold chain h. Vaccines with cold chain
traditional cold chain      
requirements requirements ( -20°C)
requirements (-20°C)
i. Vaccines with ultra cold f. Vaccines that have been
chain requirements (-       granted only Emergency
70°C) Use Listing so far
Doses per vial / j. Fewer doses per vial j. Fewer doses per vial (less
     
presentation (less than 10) than 10)
Doses per
l. Fewer doses per
regimen /       a. mRNA
regimen
course
i. Vaccines with ultra cold
Price m. Lower price      
chain requirements (-70°C)

b. Assuming two Approved Vaccines which have equivalent characteristics become available through the
COVAX Facility within 3-6 months of each other, which of the following options would you choose? Please
tick one response.
☐Implement COVID-19 vaccination with both products in your vaccine schedule to accelerate receiving and
delivering Approved Vaccines
☐Accept slower rate of receiving Approved Vaccines (e.g., by about 6 months) to avoid programmatic and
logistics complications of delivering two different products
Rationale (optional):      

6. REGULATORY AND SAFETY PREPAREDNESS INFORMATION

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Lack of regulatory and safety preparedness has delayed timely receipt of vaccines by countries in the past. The
information gathered here will be used to optimise allocation by understanding regulatory processes and
timelines of AMC Group Participants in advance.

a. Is there a defined mechanism to recognize or rely on WHO Emergency Use Listing or (EUL) or WHO
prequalification?

WHO Emergency Use Listing: Yes ☐ No ☐

WHO prequalification: Yes ☐ No ☐

b. Is there a defined mechanism to recognize or rely on regulatory decisions (marketing authorization or

emergency approval) of Stringent Regulatory Authorities (SRAs)?

Marketing authorization: Yes ☐ No ☐

If yes, please list the countries with the applicable SRA(s):      

Emergency approval: Yes ☐ No ☐

If yes, please list the countries with the applicable SRA(s):      

c. Do expedited regulatory pathways exist for approval of COVID-19 medical products (therapeutics and
vaccines) other than reliance on WHO Emergency Use Listing, WHO Prequalification and/or SRA
marketing authorisation or emergency approval?
Yes ☐ No ☐

d. What is the maximum number of working days required to obtain emergency approval, considering such
mechanisms exist (preferably in less than 15 working days)?
      working days

e. What are the requirements and list of minimum documents needed for regulatory approvals of COVID-19
products under emergency or expedited pathways defined? Please attach a copy of the emergency
and/or expedited pathway requirements/documents or provide the link if available in the public domain.
     

f. Can an import permit be issued in less than five (5) working days?
Yes ☐ No ☐
      working days

g. What are the requirements and list of minimum documents needed to import COVID-19 therapeutics or
vaccines? Please attach the list of documents needed for import permit or provide a link if available in
the public domain.
     

h. Does a lot release waiver exist or can the COVID-19 vaccine be released in less than two days by
reviewing the summary lot protocol only (testing is not required)?
Yes ☐ No ☐

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i. Is there a system that can monitor and investigate safety of emergency medical products and/or access to
global pharmacovigilance information available?
Yes ☐ No ☐

Are you a member of WHO-UMC pharmacovigilance network?

Yes ☐ No ☐

7. COLD CHAIN CAPACITY AND LOGISTICS

NATIONAL/CENTRAL COLD STORAGE CAPACITY
COVID-19 vaccines are currently under development and have differing cold chain storage requirements,
including storage at -70°C (ultra-cold chain), -20°C and/or 2-8°C 1. Please describe your present expectations of
capacity at the national/central level for storage of a COVID-19 vaccine requiring each type of cold chain
storage. For the purposes of calculation, assume a secondary packaging size per dose of 4.6cm 3 and a two-
dose regimen.

a. At the national/central level, are vaccines stored in their secondary (box) or tertiary (pallet) packaging?
Secondary☐ Tertiary ☐

b. Please complete the table below.

Storage requirement What is your current total cold storage capacity at the
central/national level?
2-8°C      m3 net available
-20°C      m3 net available
-70°C (ultra-cold chain)      m3 net available

c. Please complete the table below.

Storage requirement What is the maximum shipment size At what delivery frequency
that could be received, captured (in (in weeks) could shipments
m3)? of this size be received?
2-8°C      m3       weeks
-20°C      m3       weeks
-70°C (ultra-cold chain)      m3       weeks

d. Please complete the questions below on contingency cold chain storage (additional storage capacity not
currently available but that could be made available if there is a need and the national cold chain
capacity is insufficient).

Is there contingency cold chain storage capacity?

Yes ☐ No ☐

Do you require a storage reefer container for cold chain storage?

Yes ☐ No ☐

Please complete the table below:

1
Of candidates currently under development, one requires storage at -70°C, one at -20°C, and the rest at 2-8°C.

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Storage requirement Total contingency cold chain storage capacity

2-8°C       m3 net available
-20°C       m3 net available
-70°C (ultra-cold chain)       m3 net available

e. Please complete the questions below on contingency ambient storage:

Is contingency storage capacity available for ancillary items?
Yes ☐ No ☐

Do you require a storage container for the storage of ancillary items?

Yes ☐ No ☐

AIRPORT(S) FOR DELIVERY (INTERNATIONAL SHIPMENTS)

Code Name Opening Consignee Repacking/cold storage available? Clearing
hours Agent
                        Yes ☐ If yes, please describe the cold storage      
capacity in the following table.
No ☐ If no, please specify:
 Do you have a pre-clearance
process to pick up the
Approved Vaccines upon
arrival?
Yes ☐ No ☐
 How many days in advance
the pre-advice document for
the Approved Vaccine
shipment are needed?
      days

COLD CHAIN STORAGE CAPACITY PER AIRPORT OF ENTRY

Port of Entry Name:       Port of Entry Code:      
Cold chain storage capacity       m3 net available (2-8°C)
      m3 net available (-20°C)
      m3 net available (-70°C)
Cold chain storage capacity available for       m3 net available (2-8°C)
COVID-19 Approved Vaccine       m3 net available (-20°C)
      m3 net available (-70°C)
Is the cold chain storage bonded? Yes ☐ No ☐
Loading/unloading handling method Manual ☐ Mechanical ☐
Estimated transportation lead time from this      hours
port of entry to first storage

DOCUMENTS REQUIRED FOR SHIPMENT

The default documents are acceptable ☐
Vaccines

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Document Original or Copy? How long in advance?

[Original/Copy] [24 hrs/48 hrs/1week/1 month/N/A]
Certificate of Analysis            
Certificate of Origin            
Packing list (batch number & expiration date)            
Free sale certificate            
Proforma invoice            
Airway bill            
Other documents if applicable2 – please list            
them:
Ancillary Items
Document Original or Copy? How long in advance?
[Original/Copy] [24 hrs/48 hrs/1 week/1 month/N/A]
Certificate of Analysis            
Certificate of Origin            
Packing list (batch number & expiration date)            
Free sale certificate            
Proforma invoice            
Airway bill            
Other documents if applicable1 – please list            
them:

2
Any non-standard documentation requirements may slow down speed of delivery and increase costs to countries.

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 Wednesday, 2 December 2020

COVAX AMC GROUP PARTICIPANT SIGNATURE FORM – PART A

Name of the AMC Group Participant would like to expand the existing partnership with Gavi for the improvement
of the immunisation programme of the Country, and specifically hereby requests COVAX Facility support for:
COVID-19 Approved Vaccine.

Name of the AMC Group Participant commits itself to developing national immunisation services on a
sustainable basis in accordance with the national health and immunisation strategic plans.

The English language version of this Application shall prevail if there is a conflict between the English language
version and a translated version.

Please note that COVAX Facility will not review this Part A of the Application without the signature of the Minister
of Health or his or her delegated authority.

The undersigned affirms that the objectives and activities in this Part A of the Application are fully aligned with
the national health and immunisation strategic plans (or equivalent), and that funds for implementing all COVAX
Facility-related activities, including domestic funds, will be included in the annual budget of the Ministry of
Health.

Minister of Health (or delegated authority)

Name:      

Date:      

Signature:

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 Wednesday, 2 December 2020

COVAX VACCINE REQUEST:

AMC GROUP PARTICIPANT NAME COVID-19 VACCINE REQUEST
FORM – PART B

Please email completed Vaccine Requests to [email protected] copying the relevant Gavi Senior
Country Manager or focal point (whichever is applicable) by December 14, 2020, to confirm participation in the
COVAX Facility. Please note that your participation will only be confirmed upon submission of both Part A and
Part B of the Application. Contact your Gavi Senior Country Manager or focal point (whichever is applicable) in
case of questions. Note that economies eligible for the COVAX AMC may request Technical Assistance to
complete the Vaccine Request.

1. INDEMNIFICATION
The supply of Approved Vaccines to the Country will be contingent on the Country first agreeing to indemnify the
applicable manufacturer against product liability claims associated with the use or administration of the
Approved Vaccine. As such, the Country will be required to enter into an indemnity agreement (the “Indemnity
Agreement”) substantially in the form of the Annex to this Part B of the Application with the relevant
manufacturer(s) and in accordance with the Gavi Grant Terms and Conditions.

The COVAX Facility is attempting to establish a no-fault compensation mechanism to provide compensation to
those individuals in any of the AMC Group who suffer a serious adverse event which is found to be associated
with the Approved Vaccine or its administration (SAE). The compensation payment to be provided to the
aforementioned individuals will be in full and final settlement of any claims (whether against the manufacturer
and/or any other party involved in the distribution or administration of the Approved Vaccine) arising from or in
connection with the SAE in question.

The information gathered here will be used to optimise allocation by understanding in advance: (i) the Country’s
ability to enter into such an Indemnity Agreement(s) with manufacturer(s) and the processes and timelines for
doing so; and (ii) the ability of individuals within the Country to accept payment under the compensation
mechanism in full and final settlement of all claims in connection with the SAE in question. Please provide data
on the following aspects.

a. Does the Country provide immunity from tort litigation to vaccine manufacturers and other actors for
development activities and administration of a vaccine relating to COVID-19?
Yes ☐ No ☐

b. Will legislation be required to be passed within the Country in order for the Country to be able to (a) enter
into Indemnity Agreement(s) with manufacturer(s) of Approved Vaccines; and/or (b) be able to indemnify the
manufacturer(s) of Approved Vaccines as required under the Indemnity Agreement;
Yes ☐ No ☐

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 Wednesday, 2 December 2020

c. If legislation is required in response to the question above, please indicate how long in weeks it would take
the Country to pass all relevant legislation for the Country to enter into, and/or provide the indemnification
required under, the abovementioned Indemnity Agreement(s) with manufacturer(s).
      weeks

d. Please indicate who (position title, and name of current holder of position) has the necessary authority to,
in the name and on behalf of the Country, enter into such an Indemnity Agreement with manufacturer(s) of
Approved Vaccines allocated to the Country.
Position title:      
Name of current holder of position :      

e. Please indicate how long it would take in weeks for the Country to enter into such an Indemnity Agreement
with the manufacturer(s).
      weeks

f. Will legislation need to be passed within the Country in order to enable individuals who suffer an SAE
found to be associated with an Approved Vaccine or its administration to accept payments under the
compensation mechanism in full and final settlement of any claims arising from or relating to such SAE?
Yes ☐ No ☐

g. If legislation is required in response to the question above, please indicate how long it would take in weeks
for the Country to pass all relevant legislation to enable individuals who suffer SAEs found to be associated
with an Approved Vaccine or its administration to accept payments under the compensation mechanism in
full and final settlement of any claims arising from or relating to such SAE.
      weeks]

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 Wednesday, 2 December 2020

COVAX AMC GROUP PARTICIPANT SIGNATURE FORM – PART B

Please note that COVAX Facility will not review this Part B of the Application without the signatures of both the
Minister of Health and Minister of Finance or their delegated authority.

We, the undersigned, affirm that the objectives and activities in this Application are fully aligned with the national
health and immunisation strategic plans (or equivalent), and that funds for implementing all COVAX Facility-
related activities, including domestic funds, will be included in the annual budget of the Ministry of Health.

We, the undersigned, confirm the Country’s agreement and understanding that supply of Approved Vaccine is
contingent upon the Country first entering into an Indemnity Agreement, substantially in the form of the Annex to
Part B of the Application with each manufacturer of an Approved Vaccine allocated to the Country and in
accordance with the Gavi Grant Terms and Conditions as set out in Part, A of the Application.

Minister of Health (or delegated authority) Minister of Finance (or delegated authority)

Name:       Name:      

Date:       Date:      

Signature: Signature:

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 Wednesday, 2 December 2020

ANNEX - INDEMNITY AGREEMENT

[Note: Form of Indemnity Agreement to be inserted]

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