A drug patent lawyer chum just sent me this

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It's a link to a vaccine supply contract signed by the EU and in the public domain.

It's far too long so don't even try to read it, but what's most interesting about it is on p10.

First, the manufacturer does NOT promise to supply the vaccine - only to do their best to supply. That's a huge difference. (This is the operative clause: "the contractor commits to use reasonable best efforts (i) to obtain EU marketing authorisation for the Product and (ii) to establish sufficient manufacturing capacities to enable the manufacturing and supply of the contractually agreed volumes of the Product to the participating Member
States".)

Second, "reasonable best endeavours" is a defined term: "a reasonable degree of best effort to accomplish a given task, acknowledging that such things as, without limitation, the complex and highly regulated nature of the Product; the timely availability of raw materials, inventories and liquid funds; yield of process; the success of necessary clinical trials programs to support safety and immunogenicity data for the Product; the approval of the final Product formulation; contractor's commitments to other purchasers of the Product; other reasons relating to the uncertainties of producing a new vaccine for a new disease with an mRNA platform for which vaccines have not yet been registered by regulatory authorities; and any other currently unknown factors which may delay or render impossible, contractor's successful completion of the particular task, including without limitations,developing a suitable production process as may be required for a new strain of virus, ramping up capacity at contract manufacturing partners, meeting delivery schedules and obtaining the EU marketing authorisation may be beyond the complete control of the contractor, provided, however, that the contractor shall not be required to take any actions inconsistent with past practice, ordinary course of business, prudent and reasonable business behaviour and/or the contractor's budget plannings at the date hereof"

My friend says that this is very likely to be standard form wording and thus in the AZ contract too and if it is, as she pithily put it, "AZ should tell them to go f**k themselves"

Posted By: Old Git on January 28th 2021 at 15:10:01

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