3 ms·
A few highlights: 1.9 “Best Reasonable Efforts” means (a) in the case of AstraZeneca, the activities and degree of effort that a company of similar size with a
by pastapriest 6y ago
A few highlights:
1.9 “Best Reasonable Efforts” means
(a) in the case of AstraZeneca, the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a
Vaccine at the relevant stage of development or commercialization having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in
serious public health issues, restrictions on personal freedoms and economic impact, across the world but taking into account efficacy and safety; and
1.15 Indicates what costs the EU will cover. Essentially EU will pay for AZ to build capacity, pays all materials, staff (incl. overtime), facility operating and AZ's admin costs (incl. legal, finance, executive, ..), regulatory filing costs, ....). So AZ comes out of the deal with no formal "profit" but new machinery, lots of staff costs paid, lots of studies paid, and all the IP.
4.2(b): Commission has the right to request all data on the production - so they will surely request this to see where doses are actually going.
5.2 and 5.4: Explicitly specified that AZ shall use its "Best Reasonable Efforts" to manufacture the Vaccine within EU - and the UK. So explicitly UK sites are included. Commission or EU countries may prod AZ to license other manufacturers to also produce further doses.
7.2 The Commission sent EUR 336 Mio when signing the contract, and (7.1) before production sends more funding to cover the cost of materials (number blacked out but 7.4 suggests that it might be up to EUR 870 Mio)
13.1(e) AZ warrants that "(e) 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". Essentially it has no conflicting obligations for delivering those same doses. It might be difficult to identify what are the exact doses, but given that the EU transferred at least EUR 300 Mio, which in 1.15 and 7 is specified explicitly as covering all the development, capacity building, materials and production costs, it would be hard to argue that that is not a float to manufacture the first doses. This seems a difficult clause and could hang AZ if it comes out that they prioritised UK doses. See above - UK manufacturing sites were explicitly included as manufacturing sites in 5.4.
14. The EU countries indemnify AZ from any damage claims from harm caused by the vaccine's use. 15.1 also says as long as EMA has authorised the vaccine no EU country can claim damages due to safety or efficacy issues.
18.5(b) Any legal case will go before the courts in Brussels, Belgium (that's in the first instance a local court, not the Luxembourg or Hague-based ones handling EU law).
18.7 gives a force majeure clause, but explicitly excludes "defaults of service, defects in equipment or material or delays in making them available".
page 34 - signatures were made on 27 August! The beginning of the contract gives some possible delays though, if EU countries are slow to sign up.
page 40 - sadly the schedule is blacked out.
tl;dr: My takeaway from this is that AZ signed a contract that obliges them to deliver. While there's a best effort clause it's very wide. They explicitly included UK facilities as production facilities (contradicting their public claims that they only promised to use EU facilities) and committed there's no competing claim, so either signed a false warrant or the UK has no prior purchase right.