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R
equest that the Minister of Finance give an indemnity in favour of
Janssen Pharmaceutica NV under section 65ZD of the Public
F
inance Act 1989
Introduction
1.
Negotiations have concluded on a definitive advance purchase agreement (APA) for
the purchase of vaccines from Janssen Pharmaceutica NV (Janssen).
2.
Ministers agreed to non-binding heads of terms forming the basis of this APA in
November, and both parties agreed at that time to negotiate a definitive APA within
four weeks. The heads of terms demonstrated the parties’ intention to conclude a
binding agreement but do not constitute a legal obligation on Janssen to supply their
vaccine candidate to New Zealand.
3.
Janssen has offered New Zealand two million courses of its vaccine candidate (known
as Ad26.COV2.S) 9(2)(ba)(i) & (ii)
and an option to purchase a
further three million courses 9(2)(ba)(i) & (ii)
. The candidate is an inactivated viral
vector vaccine.1 It will cost
cou
9(2)(ba)(i) & (ii)
rse which Janssen represents as a non-profit
global pandemic price. If successfully developed and delivered this vaccine purchase
will cost
9(2)(ba)(i) & (ii) million (which requires a total of
9(2)(ba)(i) & (ii) million to be set aside to address
foreign exchange risk).2 9(2)(ba)(i) & (ii)
4.
Similarly to the other three priority vaccine candidate suppliers, negotiations with
Janssen have been prioritised because there is high confidence in the ability of the
supplier to develop, manufacture and deliver a COVID-19 vaccine to required quality
standards.
5.
While there are inherent risks to the delivery time of all vaccine candidates, this vaccine
has the potential to be one of the small group that are likely to be available within the
timeframe needed to implement an immunisation programme in New Zealand over 2021
and 2022.
6.
The terms of Janssen’s offer to sell the vaccines to New Zealand are contained in the
APA attached as Annex One. The substantive terms of the proposed APA were
agreed in the non-binding heads of terms arrangement executed in November. The
APA also includes a number of general supply terms, not inconsistent with the non-
binding arrangement and commonly found in agreements for the purchase of
medicines.
7.
Upon conclusion of the APA the following payments will be due:
9(2)(ba)(i) & (ii)
1 The candidate is a non-replicating viral vaccine, which works by carrying DNA into human cells that then produce vaccine
antigen. The antigen provokes an immune response to the disease.
2 The sale price is denominated in USD and the vaccine costs
c
9(2)(ba)(i) & (ii) ourse. Using today’s indicative NZD-USD exchange rate
of 0.6595 the estimated cost of each
v
9(2)(ba)(i) & (ii) accine is
.
9(2)(ba)(i) & (ii) Five million vaccines costs
mi
9(2)(ba)(i) & (ii)
llion which would be
m
9(2)(ba)(i) & (ii)
illion. There is a foreign exchange risk and the Treasury have recommended including headroom of
mi
9(2)(ba)(i) & (ii)
llion
to address that risk. Therefore the amount required to be set aside for the purchase is
mi
9(2)(ba)(i) & (ii)
llion.
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8.
Officials are not recommending exercising the option to purchase the additional three
million courses at this stage because further relevant information may become
available before this decision is necessary. 9(2)(ba)(i) & (ii)
9.
Officials believe there is a strong rationale to sign the APA because:
a.
Subject to successful clinical trials, this vaccine is likely to be the only single-
dose vaccine available in the timeframe suitable for the immunisation
programme.3 A single-dose regimen is significantly more straightforward to
administer than a two-dose regimen and avoids the risk of people failing to
present for their second dose. It is being offered in quantities sufficient for wide
population use.
b.
Janssen, along with its parent company Johnson & Johnson, has a very strong
track record in producing safe and efficacious pharmaceutical products for use
globally and in New Zealand. This gives us confidence in their ability to develop,
manufacture and deliver a vaccine to prescribed standards.
c.
We have negotiated terms that we believe are satisfactory, and are in line with
global trends for COVID-19 vaccine advance purchase arrangements.
d.
It is one of the most purchased vaccine candidates. Together, the USA, the UK,
Canada and the EU have advance purchase arrangements with Janssen for
around 570 million courses of this vaccine candidate.4 Those countries have
used similar frameworks to ours, using their experts to interrogate the early
science results, trial designs and manufacturing programmes.
e.
The Janssen candidate will populate the portfolio with a viral vector vaccine that
offers broad population cover (we have 3.8 million courses of the other viral
vector candidate in the portfolio – the AstraZeneca candidate – which we are
seeking to top up through the COVAX Facility).
f.
Being a potentially single-dose regimen this vaccine candidate could be better
suited for use in the Pacific or for harder-to-reach populations than other
candidates.
10. The major disadvantage of this vaccine is that its shelf-life is currently measured to be
three months. This may extend once further testing has been completed.
11. As part of the APA, Janssen is seeking an indemnity from the Crown 9(2)(ba)(i) & (ii)
The indemnity will
only apply to the extent loss is not covered, or claims are not barred, by the Accident
Compensation Act (AC Act). 9(2)(ba)(i) & (ii)
12. Janssen are seeking the indemnity because:
3 9(2)(ba)(i) & (ii)
4 The USA has purchased 100 million courses, the UK has purchased 30 million courses, Canada has purchased 30 million
courses, and the EU has purchased 400 million courses.
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a) they are developing the vaccine in accelerated clinical trials that are less likely
than non-accelerated trials to detect uncommon adverse effects or possible
contraindications; 5 and
9(2)(ba)(i) & (ii)
13. This document sets out the business case for the indemnity that we have negotiated,
taking into account advice from our external legal adviser Bell Gully.
14. The business case incorporates the information and advice from our external legal
advisers that we provided to the Treasury about the indemnity in November (attached
at Annex Two), with two key updates:
An assessment of the indemnity-like obligations in the agreement
A comparison of the indemnity with indemnities negotiated with AstraZeneca
and Novavax as well as Pfizer.
Background
15. It is not unexpected for pharmaceutical companies to seek indemnities from
governments in circumstances where clinical trials are restricted, or approval is
granted before full trials are completed.
16. As part of purchase agreements for COVID-19 vaccines, the Minister of Finance
granted indemnities in favour of Pfizer/BioNTech on 5 October, Novavax on 15
December and AstraZeneca on 15 December.
17. Indemnity clauses are also common in APAs between pharmaceutical companies and
governments internationally for the supply of pandemic influenza vaccines. The
Minister of Finance has given an indemnity in relation to influenza vaccine on four
occasions.
Our aim in negotiations on indemnity is to minimise the Crown’s liability
18. In order to minimise the Crown’s liability, in negotiations with pharmaceutical
companies we are seeking 9(2)(j)
5 Janssen will provide Medsafe with full clinical trials information when they apply for regulatory approval. Study designs and
regulatory approaches will vary between COVID-19 vaccine applicants, but most trials will be shorter in length and study fewer
people than what is typical. The impact is a reduction in the known safety profile of the vaccine (noting that there is some risk in
this area even with comprehensive trials)
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9(2)(j)
Scope of the indemnity
9(2)(ba)(i) & (ii)
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9(2)(ba)(i) & (ii)
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9(2)(ba)(i) & (ii)
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9(2)(ba)(i) & (ii)
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24.
Bell Gully has provided the following explanation of the provisions:
9(2)(h), 9(2)(ba)(i) & (ii)
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9(2)(h), 9(2)(ba)(i) & (ii)
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9(2)(h), 9(2)(ba)(i) & (ii)
31. A table comparing the Janssen, Pfizer, AstraZeneca and Novavax indemnities is
attached at Annex Three.”
9(2)(ba)(i) & (ii)
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Exp
osure, risk and mitigation
ACC wil cover most of the Crown’s liability for adverse effects associated with use of the
vacci
ne
33. ACC can cover personal injuries arising from the administration of a vaccine by a
registered medical professional.6 Costs to ACC related to use of the vaccine in New
Zealand will arise regardless of the provision of contractual indemnity.
The liability associated with claims not covered by ACC is relatively low-risk
34. Bell Gully has advised that “[o]verall, the risks associated with claims which would not
be covered by the AC Act seem likely to be relatively low (particularly when assessed
against the risks of not accessing a vaccine), with the Crown able to take certain steps
to protect its position as far as possible. However, the exact risk in each case will
depend upon the nature of the vaccine (including its efficacy and side effects) as well
as how widely the vaccine is ultimately used in the population.
9(2)(h), 9(2)(ba)(i) & (ii)
6 Access to cover depends on the circumstances of the injury – including that there must be a clear causal link between the
treatment and the injury, and the injury must not be a necessary part or ordinary consequence of the treatment.
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9(2)(h), 9(2)(ba)(i) & (ii)
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9(2)(h), 9(2)(ba)(i) & (ii)
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9(2)(h), 9(2)(ba)(i) & (ii)
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9(2)(h), 9(2)(ba)(i) & (ii)
9(2)(j), 9(2)(h), 9(2)(ba)(i) & (ii)
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9(2)(j), 9(2)(h), 9(2)(ba)(i) & (ii)
44. Bell Gully advises that it is not possible at this stage to estimate the maximum potential
liability the Crown could incur under the Janssen indemnity because “there remains
too great a range of uncertainties, including around the risks associated with the
vaccine and its side effects, its physical properties and how it will be deployed in New
Zealand.”
There are measures in place to mitigate the risk of injuries
45. As noted above, ACC cover is likely to be available for most injuries caused by the
vaccine. Injuries could also, however, result in claims not barred by the Accident
Compensation Act – for example claims for 9(2)(ba)(i) & (ii)
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9(2)(ba)(i) & (ii)
– though as noted
above, Bell Gully considers these risks to be relatively low.
46. Janssen’s (and its parent company Johnson and Johnson’s) very strong track record in
producing safe and efficacious pharmaceutical products for use globally and in New
Zealand, and associated capability to facilitate or support the distribution, tracking and
recall of a vaccine, mitigates the risk of treatment injuries associated with use of the
vaccine. Other measures to mitigate the risk of injuries include:
Medsafe will be undertaking a
risk-benefit assessment as part of the regulatory
approval process to ensure the vaccine meets internationally accepted criteria for
safety, quality and effectiveness. Medsafe will also be seeking its own independent
expert advice and will work with regulators globally (e.g. FDA, EMA, TGA) to assess
the safety and efficacy of the Janssen vaccine.
9(2)(ba)(i) & (ii)
Medsafe is developing a strategy for
monitoring the vaccine once it is being used.
This may include adverse reaction reporting, active monitoring (via SMS text and real
time analysis), requirements on companies to provide adverse reaction information
globally, and sharing monitoring data with other regulators to identify safety issues.
This monitoring will allow Medsafe to take timely action if a safety issue emerges.
Replacement of the National Immunisation Register with a new
National
Immunisation Solution (expected in Q1 2021) to monitor who has received doses of
the vaccine.
Requirements on the supplier to have a
risk management and post-marketing
surveillance programme 9(2)(ba)(i) & (ii)
We are working to mitigate additional risks associated with the indemnity
47. A key aspect of our communications and engagement approach is to
acknowledge
that public expectations of potential vaccines may be unrealistic, and to
actively
manage these expectations as part of our stakeholder and public communication.
This will help to mitigate the risk of any claims relating to an ineffective vaccine or
negligent misstatement.
48. The indemnity could
reduce public confidence in the vaccine and therefore reduce
uptake. This might cause a flow-on in
reduced public confidence in vaccines in
general, potentially reducing immunisation rates for other diseases. This could
ultimately result in reduced public confidence in the government and the health
system.
49. To mitigate this risk, which will apply to all indemnities in APAs, we are seeking to limit
the scope of indemnity provisions as far as possible. In addition, we will develop key
messaging that provides context around the potential issue of indemnity in the event of
public or media interest (noting that the indemnity will be public knowledge at some
stage because the Minister of Finance is required to table a statement about the
indemnity in the House “as soon as practicable after giving the indemnity” and such
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statements have already been tabled in relation to the Pfizer indemnity and our
involvement with the COVAX Facility).
9(2)(ba)(i) & (ii)
that is relevant to
the decision under the authorising provisions in the Medicines Act.
9(2)(ba)(i) & (ii)
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9(2)(ba)(i) & (ii)
Termination Arrangements
9(2)(ba)(i) & (ii)
Necessary or Expedient in the Public Interest
59. The Public Finance Act says that the Minister of Finance may grant an indemnity if it
appears to the Minister to be necessary or expedient in the public interest.
The indemnity is in the interest of the New Zealand public because its benefits
outweigh its risks
60. The meaning of “public interest” depends on the circumstances and can be
multi-faceted, but it is generally accepted that it is broadly equivalent to the public good
or what is in the best interests of society. In the context of the Public Finance Act the
public interest can be viewed as the interest of the New Zealand public.
61. We judge that the indemnity is in the interest of the New Zealand public because the
benefits that it will bring to New Zealand (outlined below) outweigh the risks to the
Crown that Bell Gully has identified (described in the “exposure, risks and mitigation”
section).
The key benefit of the indemnity is that it will allow New Zealand to conclude a
bilateral APA with Janssen
62. An APA with Janssen will in turn bring the below benefits to the Crown and to the New
Zealand public.
63. An APA with Janssen will contribute to our portfolio of APAs for promising vaccine
candidates.
64. A portfolio approach is intended to manage a range of risks and provide safe and
effective vaccines to choose from for early deployment as part of New Zealand’s
immunisation strategy. This improves the chances of acquiring vaccines that can
support achieving population cover from COVID-19 in a timely manner. The
construction of the portfolio therefore requires the selection of vaccine candidates that
ensure diversity across technology platforms, vaccine characteristics, suppliers, and
timeframes, and that are suitable for use in the Realm of New Zealand and other
Polynesian countries.
65. The Janssen vaccine plays a key role in New Zealand’s core vaccine portfolio: it is a
promising candidate that is potentially a single-dose vaccine and available in sufficient
quantities to provide wide population cover within the timeframes required to
implement the immunisation programme.
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66.
The single-dose format offers a potentially simpler deployment model than other
vaccines under consideration. Janssen’s trial design is broad in its coverage of
different population cohorts, meaning that there is a realistic prospect of it being
delivered widely across the New Zealand population, including hard-to-reach and at-
risk population groups such as the elderly and those with chronic medical conditions.
67.
Broad population coverage purchases provide significant benefit to the portfolio as
they reduce the need for multiple candidates to succeed before we are able to achieve
wide population cover. On the other hand, the vaccines that could offer broad
coverage all have different drawbacks that could prevent their widespread use. This is
why we are building a portfolio of vaccines: to maximise options for the immunisation
programme, and increase our chances of having safe and effective vaccines for
population-wide deployment. This reflects the approach taken by other countries using
similar purchase frameworks to ours, and a number have purchase agreements for
both of these viral vector candidates.
68. 9(2)(ba)(i) & (ii)
The limited shelf-life of the Janssen vaccine and
constrained storage facilities have the potential to limit its use in the Pacific despite its
advantageous potentially single-dose format. We are hopeful that as more data is
collected, the recommended shelf-life of the vaccine will improve.
69. The vaccine could bring economic and social benefits to New Zealand if it is
successful and Medsafe judges it to be safe and effective for use in New Zealand, and
it is rolled out as part of the immunisation programme.
70. Immunisation could help reduce severity of illness among those who are vaccinated,
ensure our health system is not overwhelmed, and provide a level of immunity from
COVID-19. Achieving population immunity from COVID-19 and reducing transmission
rates will also reduce and potentially eliminate our reliance on blunter tools like border
controls and lockdowns.
Economic impacts
71. The main economic impacts of a successful vaccine roll-out would be to reduce the
risks of entering high alert levels and the economic costs associated with those levels,
and to enable a relaxation of border restrictions. Immunisation is the only public health
tool that would reduce the level of threat posed by COVID-19, rather than shielding
against the disease as our other tools (e.g. isolation, testing, and restrictions on
movement) are designed to do.
72. If a successful vaccine or therapeutic sufficiently reduced the level of threat posed by
COVID-19, and thus contributed to a relaxation or eventual removal of border
restrictions, we do not anticipate an immediate recovery in international travel to levels
seen prior to the COVID-19 pandemic. This reflects negative impacts on household
income and a possible change in traveller behaviours, while it may take some time for
capacity on international air routes to be re-established.
73. The Treasury estimates that nationwide Alert Level controls have the following impacts
on GDP:
Level 4
25%-30%
Level 3
15%-20%
Level 2
6%-10%
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Level 1
3%-5%
Note the estimated economic costs of different Alert Levels are based on historical
data, and do not reflect how firms and households adapt behaviour, nor do they
reflect the changes in Government policy.
74.
The Pre-election Economic and Fiscal Update (PREFU), assumes a combination of
Alert Level 3 and 2 restrictions lasting approximately four weeks in the September
2020 quarter. Alert Level 1 restrictions are then assumed to apply until 1 January
2022.
75. The main scenario in PREFU assumes that border restrictions are to be lifted on 1
January 2022. However, travel services exports, including tourism and international
education services, are assumed to start recovering from the September 2021 quarter
onwards, reflecting the possibility of safe travel arrangements being agreed. This will
allow some services exports and non-New Zealander net migration to resume.
However, the effects of COVID-19 will continue to be far-reaching and the pace at
which services exports such as tourism and international education will recover
remains uncertain.
76. 9(2)(ba)(i) & (ii)
77. In August the Minister of Foreign Affairs agreed in principle that Official Development
Assistance could be used to reimburse the cost of vaccines passed on to Polynesian
countries.
78. Earlier this month, Cabinet agreed that up to $75 million be allocated from Vote Official
Development Assistance to support Pacific and global access to COVID-19 vaccines,
and that New Zealand should actively seek to purchase up to 360,000 additional
doses of at least one suitable COVID-19 vaccine candidate specifically for Polynesia.
The purchase should be funded from within that allocation [CAB-20-MIN-0504].
79. We are working through the issues that provision of vaccine to Pacific countries would
raise, which 9(2)(ba)(i) & (ii)
include distribution of vaccine doses,
additional support required, ensuring the vaccines are appropriate for the Pacific
environment, and how the transfer of funding and/or cost-sharing might be
operationalised.
Granting the indemnity to Janssen is expedient in the public interest
80. The word “expedient” is not defined in the PFA but Crown Law has advised that there
is authority in differing contexts that it means “fitting”, “suitable”, “desirable” or
“convenient”.
81. Granting the indemnity in order to conclude an APA with Janssen is expedient
because it will help us achieve our Vaccine Strategy objective of securing enough safe
and effective vaccines for New Zealand and Polynesia.
82. In order to achieve this objective, we need a portfolio containing at least four
candidates with diverse technology platforms and characteristics, in quantities
sufficient for broad population cover.
83. To have the best chance of achieving population immunity from COVID-19 as soon as
possible, we need to purchase vaccines through bilateral APAs. This route offers
faster access to vaccines than others would (e.g. purchasing vaccines solely through
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the COVAX Facility, which is capped at doses for 50% of our population with an
uncertain end date for delivery). Domestic manufacturing of COVID-19 vaccines is also
not viable in the short term, because vaccine developers we have been in negotiations
with have already made manufacturing arrangements for the vaccines they intend to
produce in the next year or two.
84.
At this stage our portfolio is still under construction. So far we have:
3.8 million courses of the AstraZeneca candidate (another viral vector vaccine),
which we are seeking to supplement with a top-up purchase through the
COVAX Facility (briefing MBIE-2021-0858 refers), and
5.36 million courses of the Novavax candidate, a protein sub-unit and adjuvant
vaccine.
85. Concluding the APA with Janssen is critical to securing a ‘corner-stone’ vaccine in our
portfolio: a potentially single-dose vaccine offering wide population cover.
86. We also have 750,000 courses of an mRNA vaccine candidate from Pfizer Inc.
9(2)(ba)(i) & (ii)
87. 9(2)(ba)(i) & (ii)
This increases the importance of
securing Janssen’s vaccine for our portfolio. The needs of our vaccine portfolio could
change as more information is known, but at this stage, the Vaccine Taskforce
considers that the core portfolio has insufficient vaccine options that are available in
sufficient quantities to provide five million courses, and without the Janssen purchase
the portfolio would be even less resilient.
82. We will also investigate the purchase of another wide-coverage candidate and
continue to consider smaller purchases, including through the COVAX Facility.
88. Not purchasing the Janssen candidate would have the following implications for the
portfolio:
We may need to consider purchasing a different vaccine candidate to form the
core portfolio of four candidates with wide coverage. There is only one viable
alternative at present, based on negotiations already underway. That vaccine
candidate has not yet reported results from human trials, 9(2)(ba)(i) & (ii)
we
would be unlikely to recommend purchasing that candidate until we have more
information.
If an alternative to the Janssen vaccine candidate was not pursued, the
portfolio would only have two vaccine candidates that can offer wide population
coverage. It may still have one candidate from each of the three main platforms
we are targeting, but there would be reduced optionality for the immunisation
programme when deciding what vaccines to deploy and when.
Overall Judgement
89. We judge that the benefit of the APA to New Zealand outweighs the risk and justifies
granting the indemnity.
90. Bell Gully has advised that:
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the risks associated with claims 9(2)(ba)(i) & (ii)
which would not be covered by the AC
Act seem likely to be
relatively low, with the Crown able to take certain steps
to protect its position as far as possible.
9(2)(ba)(i) & (ii)
Risk Management
91. The Ministry of Health and other agencies are putting in place the risk management
measures as outlined in the “Exposure, Risk and Mitigation” section above.
Other considerations
92. The business case reflects specific legal advice (legally privileged) from Bell Gully and
Crown Law as referred to in the text. Bell Gully has also reviewed this document.
Responsible Minister Briefing
We are briefing responsible Ministers in parallel with submitting the business case to
the Treasury, in order to conclude the agreement with Janssen as quickly as possible.
The APA needs to be executed without delay to secure access to the available
Janssen vaccines.
Notification Requirements
93. We have provided a draft notice for the indemnity because the exposure is
unquantifiable. This statement is intended to be tabled in the House of
Representatives once the indemnity is given, and the Definitive Agreement is signed.
Statement of Indemnity given under the Public Finance Act 1989
Pursuant to section 65ZD(3) of the Public Finance Act 1989, the Minister of Finance makes
the following statement:
On [date] I, Grant Robertson, Minister of Finance, on behalf of the Crown, gave an indemnity
in favour of Janssen Pharmaceutica NV and specified associated persons in relation to the
supply of a COVID-19 vaccine.
Dated at Wellington this [insert date of month] day of [insert month] [insert year].
Hon Grant Robertson
Minister of Finance
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R
ecommendation
The Ministry of Business, Innovation and Employment and the Ministry of Health recommend
that the Minister of Finance approve the giving of the indemnity in favour of Janssen
Pharmaceutica NV on the terms outlined in Annex One.
Peter Crabtree
Delegate of Chief Executive Carolyn Tremain
Ministry of Business, Innovation and Employment
Maree Roberts
Deputy Director-General, System Strategy and Policy
Delegate of Director-General and Chief Executive Dr Ashley Bloomfield
Ministry of Health
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A
nnex One: Supply agreement
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A
nnex Two: information provided to the Treasury in November 2020
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Annex Three: indemnities comparison (supplied by Bell Gully)
Pfizer Indemnity
AstraZeneca Indemnity
Janssen Indemnity
Novavax Indemnity
9(2)(ba)(i) & (ii)
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Pfizer Indemnity
AstraZeneca Indemnity
Janssen Indemnity
Novavax Indemnity
9(2)(ba)(i) & (ii)
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Pfizer Indemnity
AstraZeneca Indemnity
Janssen Indemnity
Novavax Indemnity
9(2)(ba)(i) & (ii)
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