What exactly is happening with AstraZeneca?

fly_agaric

mick087 wrote: »

I have no idea why your bringing the UK into this or the IMO THE unelected nonsense they have over there?

If the European citizens did have a choice to vote for this western leader you talk about then the citizens will decide. And if citizens was not happy with this western leader then they of course could vote him out.

I hope this answers your questions.

Well you have brought the UK into this thread on many an occasion by praising their vaccination programme and using it as evidence for EU failures + tardiness.

But yeah, I shouldn't have brought the UK government + how it runs its affairs into it and have tried not to in my posts on thread as it is not helpful.

However it gets...hard...when UK vaccination efforts are contrasted with those of the EU (and used to assign, imo, unfair blame to it over this issue with AstraZeneca vaccine shortfall).

listermint

FileNotFound wrote: »

Thanks. Good to know.

But being as the whole world knew they had signed other contracts - especially UK - and I guess they all have this jargon.

Was it not a bit of a dumb simple minded approach to take. It being written can't change reality.


Not supporting AZ, they clearly screwed up and should work hard to fix. Penalties should supply I suppose.

But a bit simple minded by the EU no?

I actually don't know how anyone could turn that clause back on the EU.

Bizarre behaviour tbh.

kieran26

FileNotFound wrote: »

May be right.

But let's say you had a contract with a builder for a 4 bed house... And agreed a build start date.

Onky thing is, when the builder shows up you haven't bought the land yet.

Is he/she to blame. Or you? For the potential impacts.

To be clear I personally think AZ have a lot to answer for but do wonder if the EU is on as solid ground as they assumed.

Really do not want to see any blocking of vaccines going out of EU - the long term impact would be massive.

All depends on what the terms of the contract with the ''Builder'' are really.

Melanchthon

McGiver wrote: »

EU order for Novavax is 100M and 100M possible

The EU was not negotiating, the EU contract needs approval from EU27 and signature by the EC.

You are aware that the UK is a single country whereas the EU is a confederation of 27 countries.

Do you have any proof that they are not still negotiating? As far as I understand it they were only in the first stage of talks in December and the Reuters article doesn't indicate negotiations had been concluded. Despite your best efforts to mislead posters we know from the Summer that the time period between a deal nearly being done and a deal being funded and signed (which is the important part) can be nearly 3 months.

Oh interesting, I had found a Daily Mail article that stated about them still being negotiating but I knew if I posted that the only reply would focus on the Paper not the contents.
So after a bit of googling.

The European Commission is in negotiations with Novavax about the amount of COVID-19 vaccines it is going to order from the U.S. company, Germany’s Health Minister Jens Spahn said on Friday

https://www.reuters.com/article/health-coronavirus-germany-officials/eu-in-talks-with-novavax-on-vaccine-purchases-germany-idUSS8N28T05H

Oh wait does that mean they are still negotiating, like if they don't know how much they are attempting to purchase it can't just be waiting for signatures from the member states.

McGiver wrote: »

CureVac and J&J are further ahead in the trials and we have secured 425M + 380M posible for these.

https://www.curevac.com/en/2020/12/14/curevac-commences-global-pivotal-phase-2b-3-trial-for-covid-19-vaccine-candidate-cvncov/

Curevac started stage 3 trials on the 14th of December, they are not complete.

Johnson and Johnson filled their trial on the 17th of December, they began the trial earlier though.
https://www.jnj.com/our-company/johnson-johnson-announces-its-first-phase-3-covid-19-vaccine-trial-ensemble-is-fully-enrolled

Interim data from the ENSEMBLE trial is currently anticipated to be available by the end of January 2021

Results are expected soon.


Novavax began trials in the UK on the 25th of September
https://www.wave3.com/2020/09/25/drugmaker-novavax-begins-late-stage-vaccine-trial-uk/

The trial results were released yesterday.


So how exactly is J&J and Curevac further ahead in the trials, when their trials are still ongoing but Novavax has completed its stage 3 trial.

It couldn't be that your just wrong could it

https://ir.novavax.com/news-releases/news-release-details/novavax-covid-19-vaccine-demonstrates-893-efficacy-uk-phase-3

McGiver wrote: »

Your eurosceptic posts are tiresome. At least use rational arguments and facts.

Your literally making stuff up thats easily disprovable and I am the one not using facts

kieran26

mick087 wrote: »

The contract was not my issue or my question.

Seems to me it is.

The terms and conditions of the contract are the only thing that matters on this issue and each contract stands on its own merits. We could sign a contact today with AZ to start poviding us with vaccines tomorrow and if they agreeed to start providing them tomorrow, they would have to abide by that agreement. It doens't matter when the agreement is signed.

trixi001

CIARAN_BOYLE wrote: »

Astra Zealand promises that they have entered into no other contracts that would delay the initial European doses (300 million).

And this was AZ's belief at the time they signed that they hadn't.

This clause actually helps AZ - as they can say that the UK contracts (and any other contracts) were irrelevant as they were always planning on supplying the EU from within the EU. This is AZ saying that they have no other contracts that will delay the EU doses, as no other region is getting supplied from the same production factories as the EU...

The UK contract probably says similar, and then the same argument is made The UK manufacture is supplying the UK, so no other contract matters...

However if the UK deliveries did come from the EU, and that this production delayed the EU manufacture, then there is maybe a case..., however if like AZ have said it was only fill and finish was done in the EU, and this didn't delay the EU order as nothing was ready from the EU production for fill and finish, its not an issue (I also think this was only a small number of doses anyway - it doesn't help that EU argument that they want the UK doses)

You can't look at just one sentence in a contract, its the whole contract matters. Contracts are tricky business and how each side interprets the same clause can differ...thats why the courts exist..however after a first reading on, on balance i suspect AZ are in the right as long as they signed in good faith with the belief the EU supplies EU, and UK supplies UK...but like i said open to interpretation

CIARAN_BOYLE

trixi001 wrote: »

And this was AZ's belief at the time they signed that they hadn't.

This clause actually helps AZ - as they can say that the UK contracts (and any other contracts) were irrelevant as they were always planning on supplying the EU from within the EU. This is AZ saying that they have no other contracts that will delay the EU doses, as no other region is getting supplied from the same production factories as the EU...

The UK contract probably says similar, and then the same argument is made The UK manufacture is supplying the UK, so no other contract matters...

However if the UK deliveries did come from the EU, and that this production delayed the EU manufacture, then there is maybe a case..., however if like AZ have said it was only fill and finish was done in the EU, and this didn't delay the EU order as nothing was ready from the EU production for fill and finish, its not an issue (I also think this was only a small number of doses anyway - it doesn't help that EU argument that they want the UK doses)

You can't look at just one sentence in a contract, its the whole contract matters. Contracts are tricky business and how each side interprets the same clause can differ...thats why the courts exist..however after a first reading on, on balance i suspect AZ are in the right as long as they signed in good faith with the belief the EU supplies EU, and UK supplies UK...but like i said open to interpretation

I believe section 5.4 which mentions UK manufacturing sites for eu doses would be heavily relied on in a court case.

Bass Reeves

trixi001 wrote: »

And this was AZ's belief at the time they signed that they hadn't.

This clause actually helps AZ - as they can say that the UK contracts (and any other contracts) were irrelevant as they were always planning on supplying the EU from within the EU. This is AZ saying that they have no other contracts that will delay the EU doses, as no other region is getting supplied from the same production factories as the EU...

The UK contract probably says similar, and then the same argument is made The UK manufacture is supplying the UK, so no other contract matters...

However if the UK deliveries did come from the EU, and that this production delayed the EU manufacture, then there is maybe a case..., however if like AZ have said it was only fill and finish was done in the EU, and this didn't delay the EU order as nothing was ready from the EU production for fill and finish, its not an issue (I also think this was only a small number of doses anyway - it doesn't help that EU argument that they want the UK doses)

You can't look at just one sentence in a contract, its the whole contract matters. Contracts are tricky business and how each side interprets the same clause can differ...thats why the courts exist..however after a first reading on, on balance i suspect AZ are in the right as long as they signed in good faith with the belief the EU supplies EU, and UK supplies UK...but like i said open to interpretation

Best wishes effort still dose not allow you to sign contracts that you cannot fullfil

mick087

fly_agaric wrote: »

Well you have brought the UK into this thread on many an occasion by praising their vaccination programme and using it as evidence for EU failures + tardiness.

But yeah, I shouldn't have brought the UK government + how it runs its affairs into it and have tried not to in my posts on thread as it is not helpful.

However it gets...hard...when UK vaccination efforts are contrasted with those of the EU (and used to assign, imo, unfair blame to it over this issue with AstraZeneca vaccine shortfall).

Yes I have commented on this being a EU and AZ issue not a UK issue.

mick087

kieran26 wrote: »

Seems to me it is.

The terms and conditions of the contract are the only thing that matters on this issue and each contract stands on its own merits. We could sign a contact today with AZ to start poviding us with vaccines tomorrow and if they agreeed to start providing them tomorrow, they would have to abide by that agreement. It doens't matter when the agreement is signed.

The courts if it goes that far will decide the contract.

Bass Reeves

mick087 wrote: »

The courts if it goes that far will decide the contract.

The problem for AZ is if it lost such a case the damages would break the comany

Pete_Cavan

5.4 makes it clear UK manufacturing sites are considered part of EU and so should be included in Best Reasonable Efforts to supply the EU. I can't see how they can argue they are making Best Reasonable Efforts while not supplying from UK sites, the two things are set out side by side here.

In 13.1 (e) AZ confirm that "it is not under any obligation, contractual or otherwise, to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the complete fulfillment of its obligations under this Agreement".

If their excuse now is that their contract with the UK is preventing them from meeting obligations to the EU, then they have made a false representation in the contract. We all know the UK contract was signed first so they were in full knowledge of obligations to them at the time of signing with EU.

...Ghost...

Very interesting to see some light has been shed on this whole contract issue. I suspected the EU had a strong position and were not just blowing hot air about AZ. Some posters (one who is threadbanned) were very critical and suggested what I was saying was nonsense based on the fact we had no view of the contract.

Well, now we do

oharach7

In terms of the location of manufacturing, there are a few relevant clauses and the position is not entirely clear cut (again reading this as a non-Belgian lawyer) but my initial reading is more in favour of the AZ position:

Clause 5.1
"Astrazeneca shall use its Best Reasonable Efforts to manufacture the Initial Europe Doses within the EU for distribution, and to deliver to the Distribution Hubs, following EU marketing authorization, as set forth more fully in Section 7.1, approximately [redacted] 2020 [redated] Q1 2021, and (iii) the remainder of the Initial Europe Doses by the end of [redacted]"

Note that the EU does not include the UK for the purposes of Clause 5.1. Effectively this clause seems to be giving the EU priority access to the EU manufacturing facilities.

Clause 5.4
"AstraZeneca shall use its Best Reasonable Efforts to manufacture the Vaccine at manufacturing sites located within the EU (which, for the purpose of this Section 5.4 only shall include the United Kingdom) and may manufacture the Vaccine in non-EU facilities, if appropriate, to accelerate supply of the Vaccine in Europe... The manufacturing site planning is set out in Schedule A"

While it may seem legalistic, it is important to note that while Clause 5.1 is an obligation to manufacture the "Initial EU Doses", clause 5.4 is a more general obligation to "manufacture the Vaccine" - it is not guaranteed that any manufacture under this clause is for a particular country. This view is further supported by the aim of the clause, which is "to accelerate supply of the Vaccine in Europe" (i.e. not solely the EU).

It is not entirely clear why clause 5.4 was included in the final contract given clause 5.1 which seems to cover much of the same ground from the EU perspective. Perhaps the idea was to encourage AZ to make best efforts to establish a wider European supply chain to provide the possibility - but not necessarily the right - for the EU to obtain additional doses and to ensure that neighbouring non-EU countries had access to a local supply chain to avoid the risk of the virus being reintroduced into the EU. This is speculation.

Clause 5.5 provides that "AstraZeneca shall notify the Commission as soon as (a) it selects initial manufacturing sites and (b) it changes any of its manufacturing sites for the Vaccine." As noted above, Clause 5.4 provides that "The manufacturing site planning is set out in Schedule A".

Schedule A is primarily relevant to determining the cost of the vaccine and mentions five manufacturing sites for "drug substance manufacturing" (two in UK) and three "drug product manufacturing" sites (one in UK) - I understand the former refers to manufacture of the vaccine itself and the latter to fill and finish in vials. There is no hierarchy of production sites in this schedule as previously stated by van der Leyen.

It seems clear from clause 5.5 that the manufacturing sites were not set in stone when the contract was signed and that they could be changed. As far as I am aware, we do not have any correspondence between AZ and the EU on which sites were selected to fulfil EU production.

Note that I have not addressed the issue of the potential misrepresentation by AZ in this post.

Hurrache

oharach7 wrote: »

It seems clear from clause 5.5 that the manufacturing sites were not set in stone when the contract was signed and that they could be changed. As far as I am aware, we do not have any correspondence between AZ and the EU on which sites were selected to fulfil EU production.

It doesn't really matter as the UK were deemed to be a EU site.

Pete_Cavan

oharach7 wrote: »

In terms of the location of manufacturing, there are a few relevant clauses and the position is not entirely clear cut (again reading this as a non-Belgian lawyer) but my initial reading is more in favour of the AZ position:

Clause 5.1
"Astrazeneca shall use its Best Reasonable Efforts to manufacture the Initial Europe Doses within the EU for distribution, and to deliver to the Distribution Hubs, following EU marketing authorization, as set forth more fully in Section 7.1, approximately [redacted] 2020 [redated] Q1 2021, and (iii) the remainder of the Initial Europe Doses by the end of [redacted]"

Note that the EU does not include the UK for the purposes of Clause 5.1. Effectively this clause seems to be giving the EU priority access to the EU manufacturing facilities.

Clause 5.4
"AstraZeneca shall use its Best Reasonable Efforts to manufacture the Vaccine at manufacturing sites located within the EU (which, for the purpose of this Section 5.4 only shall include the United Kingdom) and may manufacture the Vaccine in non-EU facilities, if appropriate, to accelerate supply of the Vaccine in Europe... The manufacturing site planning is set out in Schedule A"

While it may seem legalistic, it is important to note that while Clause 5.1 is an obligation to manufacture the "Initial EU Doses", clause 5.4 is a more general obligation to "manufacture the Vaccine" - it is not guaranteed that any manufacture under this clause is for a particular country. This view is further supported by the aim of the clause, which is "to accelerate supply of the Vaccine in Europe" (i.e. not solely the EU).

It is not entirely clear why clause 5.4 was included in the final contract given clause 5.1 which seems to cover much of the same ground from the EU perspective. Perhaps the idea was to encourage AZ to make best efforts to establish a wider European supply chain to provide the possibility - but not necessarily the right - for the EU to obtain additional doses and to ensure that neighbouring non-EU countries had access to a local supply chain to avoid the risk of the virus being reintroduced into the EU. This is speculation.

Clause 5.5 provides that "AstraZeneca shall notify the Commission as soon as (a) it selects initial manufacturing sites and (b) it changes any of its manufacturing sites for the Vaccine." As noted above, Clause 5.4 provides that "The manufacturing site planning is set out in Schedule A".

Schedule A is primarily relevant to determining the cost of the vaccine and mentions five manufacturing sites for "drug substance manufacturing" (two in UK) and three "drug product manufacturing" sites (one in UK) - I understand the former refers to manufacture of the vaccine itself and the latter to fill and finish in vials. There is no hierarchy of production sites in this schedule as previously stated by van der Leyen.

It seems clear from clause 5.5 that the manufacturing sites were not set in stone when the contract was signed and that they could be changed. As far as I am aware, we do not have any correspondence between AZ and the EU on which sites were selected to fulfil EU production.

Note that I have not addressed the issue of the potential misrepresentation by AZ in this post.

For the definition of both Initial Europe Doses and Vaccine, it says "has the meaning given in the recitals". Where are the recitals?

oharach7

Pete_Cavan wrote: »

For the definition of both Initial Europe Doses and Vaccine, it says "has the meaning given in the recitals". Where are the recitals?

The start of the contract - all the long-winded bits starting "Whereas..."

The "Vaccine" is just a generic reference to "the ChAdOx1 nCov-19 vaccine" whereas the "Initial Europe Doses" (while partially redacted) is presumably a reference to a particular number of doses meant for the EU.

Pete_Cavan

Pete_Cavan wrote: »

For the definition of both Initial Europe Doses and Vaccine, it says "has the meaning given in the recitals". Where are the recitals?

The forst two pages, all the clause that start Whereas etc.

Hurrache

Hurrache wrote: »

It doesn't really matter as the UK were deemed to be a EU site.

not for the Initial batch of 300m, only for the additional 100m or further orders

mick087

Bass Reeves wrote: »

The problem for AZ is if it lost such a case the damages would break the comany

That's what the courts are for 2 parties cannot decide who is right and who is wrong.

Pete_Cavan

oharach7 wrote: »

The start of the contract - all the long-winded bits starting "Whereas..."

The "Vaccine" is just a generic reference to "the ChAdOx1 nCov-19 vaccine" whereas the "Initial Europe Doses" (while partially redacted) is presumably a reference to a particular number of doses meant for the EU.

The only mention I see of the Vaccine there is;

WHEREAS, as part of that scale-up, AstraZeneca has committed to use its Best Reasonable Efforts (as defined below) to build capacity to manufacture 300 million Doses of the Vaccine, at no profit and no loss to AstraZeneca, at the total cost currently estimated to be _____ Euros for distribution within the EU ______ (the "Initial Europe Doses"), with an option for the Commission, acting on behalf of the Participating Member States, to order an additional 100 million Doses (the "Optional Doses").

The EU argument will be that the Vaccine does mean Initial Europe Doses.

trixi001

Bass Reeves wrote: »

Best wishes effort still dose not allow you to sign contracts that you cannot fullfil

No it doesn't - so like i said if AZ signed in bad faith, that's entirely on them

But I am guessing they didn't - they have an extensive legal team..

I am sure AZ believed they could fulfil the contract based on expected trial results and expected production yields, but production problems from the place they intended to make the product to fulfil the contract have meant they haven't been able to fulfil the promised number of doses on time..

Note - the UK also had production problems and their orders were received late too

If this goes to court, it will take months (with appeals etc), and by that time AZ will be manufacturing fully at all sites, so however the court interpret it isn't really going to make a difference to how quickly the EU gets the vaccine.

The EU is trying to play hardball by releasing the contract, as the media and others will select lines from it making it look as if AZ is definitely wrong, and hoping AZ will give them UK vaccines to avoid negative publicity (and then the UK will probably take AZ to court too, if they do so without UK government approval, although I do understand that the UK have said once over 60's and vulnerable are vaccinated, they will provide help to the EU)

Pete_Cavan

Pete_Cavan wrote: »

The only mention I see of the Vaccine there is;

The EU argument will be that the Vaccine does mean Initial Europe Doses.

Astra Zeneca will argue (and probably successfully) that if they meant that, then they should have said it. The fact they made a distinction between the two does not help the EU.

oharach7

Pete_Cavan wrote: »

The only mention I see of the Vaccine there is;

The EU argument will be that the Vaccine does mean Initial Europe Doses.

It's this bit on the top of the first page:

"This Advance Purchase Agreement (this “Agreement”) for the production, purchase and supply of the ChAdOx1 nCov-19 vaccine (“Vaccine”) in the European Union (the “EU”) is entered into as of 27 August 2020 (the “Effective Date”), by the following parties:"

Aegir makes a good point that it may be that Clause 5.1 was intended to govern the provision of the Initial Europe Doses whereas Clause 5.4 would cover the Optional Doses. I think that would be AZ's argument and it tallies with part of the interview he gave to the Italian/German press the other day.

oharach7

Aegir wrote: »

Astra Zeneca will argue (and probably successfully) that if they meant that, then they should have said it. The fact they made a distinction between the two does not help the EU.

That is a core principle of contractual interpretation in English/Irish law. But let's see what the Belgian courts say...

Pete_Cavan

Aegir wrote: »

Astra Zeneca will argue (and probably successfully) that if they meant that, then they should have said it. The fact they made a distinction between the two does not help the EU.

But equally it could be argued that if the Vaccine as mentioned in 5.4 referred only to Optional Doses or Additional Doses, then they should have said that.

I don't see how it can be argued that 5.4 only refers to 5.2 Optional Doses and 5.3 Additional Doses only but not 5.1 Initial Europe Doses. That seems to be being very selective to suit a position.

Pete_Cavan

Pete_Cavan wrote: »

But equally it could be argued that if the Vaccine as mentioned in 5.4 referred only to Optional Doses or Additional Doses, then they should have said that.

I don't see how it can be argued that 5.4 only refers to 5.2 Optional Doses and 5.3 Additional Doses only but not 5.1 Initial Europe Doses. That seems to be being very selective to suit a position.

it is the "For the purposes of this clause 5.4 only" that is the catch point. If it was supposed to also include clause 5.1, then it would have said so.

As oharach7 said though, that would be my interpretation in English/Irish law. Belgian law may differ.

(I'm not a lawyer by the way, I just read and write a lot of contracts)

Bass Reeves

Bass Reeves wrote: »

The problem for AZ is if it lost such a case the damages would break the comany

there is limitation of liability, the limit has been redacted though, so it wouldn't break the company, just cost them a **** load of money.

If you or i decided to claim because we didn't get our doses and caught covid, firstly we would have a really difficult job of pinning it on AZ, secondly they have a fairly comprehensive indemnity that would protect them anyway and our claim would be dealt with by the government.

Pete_Cavan

Aegir wrote: »

it is the "For the purposes of this clause 5.4 only" that is the catch point. If it was supposed to also include clause 5.1, then it would have said so.

As oharach7 said though, that would be my interpretation in English/Irish law. Belgian law may differ.

(I'm not a lawyer by the way, I just read and write a lot of contracts)

I see where you are coming from but the Vaccine at 5.4 has to refer to something. If that's not Initial Europe Doses, Optional Doses or Additional Doses as defined in the preceding clauses, what is it?

(I'm not a lawyer either by the way, I deal with contracts in a different industry)

oharach7

Pete_Cavan wrote: »

But equally it could be argued that if the Vaccine as mentioned in 5.4 referred only to Optional Doses or Additional Doses, then they should have said that.

I don't see how it can be argued that 5.4 only refers to 5.2 Optional Doses and 5.3 Additional Doses only but not 5.1 Initial Europe Doses. That seems to be being very selective to suit a position.

It's possible a court would say that 5.4 refers to any provision of the Vaccine (including the Initial Europe Doses), and 5.1 to the Initial Europe Doses specifically.

But there is another legal principle (again of Irish/English law) that a more specific clause will trump a more general one to the extent of a conflict. So the reference in 5.1 to the EU (excluding UK) does look problematic to me.

I don't know whether Belgian contract law would take the same view though.

(Edit: I am an English qualified solicitor with an Irish law degree by the way, but I mostly advise on loan agreements rather than commercial contracts.)