Author Archives: Mark Anderson

About Mark Anderson

I am an English solicitor (attorney) who qualified originally as a barrister in 1983. After working as an in-house lawyer and with Bristows in London, I formed Anderson & Company (now Anderson Law LLP) in 1994. Our offices are based in Oxfordshire, on the banks of the River Thames, 50 miles west of London. Outside work, I enjoy walking, swimming and canoeing. I met my wife Sara whilst cycling from Land's End to John O'Groats (1,100 miles) in 1991.

Copyright in training materials: interpreting the assignment clause

On reflection, IP Draughts wonders whether the drafter of this assignment clause was making a distinction between IP and IPR – a distinction that he dislikes but sees in some contracts. If so, this probably supports the judge’s interpretation.

IP Draughts

Dr Susie Wilkinson

Picture the scene.  You have been conducting research on communications skills for medical professionals for several decades.  You have trained nurses in communication skills and written training materials for them.  You own the copyright in these materials, some of which are based on the contents of your PhD.  You are also a published co-author of an Oxford University Press book for healthcare professionals, and are or were an honorary senior lecturer at the Royal Free Hospital in London.

You are asked to participate in a joint bid to write training materials on the subject of communication skills in relation to the treatment of cancer patients.  These materials are to be used nationally by the UK National Health Service (“NHS”).  You are happy for the copyright in these materials to belong to the NHS, provided you do not lose ownership to your pre-existing intellectual property (“IP”).

The…

View original post 559 more words

Leave a comment

Filed under Uncategorized

Clinical trial agreements: thriving in ambiguity?

IP Draughts has recently advised several clients on clinical trial agreements (CTAs) and related contracts, including manufacturing agreements and agreements with clinical research organisations (CROs). The experience has left him reflecting about how this area of practice is an odd mixture of precision and vagueness, of formal procedures and finding ad hoc solutions, of strict regulatory compliance and muddling through the best one can, and where the scientific values of accuracy and taking a long-term view often run up against a commercial need to advance one’s product through trials ahead of the competition and before the development money, or investors’ patience, runs out.

In the UK, there is also sometimes a contradition, not found in some other countries, between the commercial aspects of running trials and paying fees to a hospital, and the non-commercial values and attitudes of National Health Service (NHS) hospitals and the people who work in them.

Instances of these contradictions include:

  1. Worldwide documentation. The need to comply strictly with national or regional (eg EU) regulations governing the conduct of trials, data protection and privacy, freedom of information, insurance and indemnities. But some of these regulations are complex, subject to change (eg EU data protection regulation), and vary between countries, while many clinical trials are conducted on a worldwide basis, using a single set of documentation wherever possible. Some of the language used in this documentation has clearly been designed under a different regulatory system to the one in which it is being used.
  2. Different skill-sets. The contracts that one encounters usually attempt to be in alignment with the regulatory system with which the drafter is familiar, at the time of drafting. But often they are drafted by non-lawyers and/or negotiated by non-lawyers, and used for several years without substantive review. They can and do end up with incorrect, misleading or outdated references to regulatory compliance, e.g. referring to guidelines rather than the relevant law, using terminology designed for a different type of trial, or a trial in a different country, or incorporating contradictions between obligations in documents designed for the same trial by different professionals, e.g. the Protocol (medical and ethical drafters), the Technical Agreement (regulatory and manufacturing drafters) and the CTA (financial, commercial and, one hopes, legal drafters).
  3. Poor source documents. This blog has previously commented on some of the oddities in the model NHS CTAs, e.g. the limit of liability for deliberate breach to twice the contract price. IP Draughts finds it difficult to believe that this strict limit, which he has never encountered in any other contract in over 30 years of practice, would be upheld by a court. Though he has no case authority directly to support this argument, he wonders whether a court would find such a limit unenforceable under the Unfair Contract Terms Act 1977, in view of the need for liability terms in written, standard terms of business to be reasonable. There are plenty of other examples of oddities in the NHS CTAs, which seem to be have been driven by commercial or financial priorities and to underplay the importance of clear, accurate, and legally-valid drafting. And yet he is told that the template CTAs in use in many other countries are much worse than the UK templates.
  4. Varying quality and availability of advisers. It is sometimes difficult for trial sponsors to find advisers and consultants who have significant experience of clinical trials and the associated legal issues in the jurisdiction in which the trial is taking place. For example, one of IP Draughts’ clients is currently looking for a legal adviser in Finland. Is any reader able to recommend someone suitable? A separate issue relates to CROs. Although he has not studied the subject in depth, IP Draughts has the impression that the market for CROs is dominated by a few international providers. He has heard stories of some large CROs taking weeks to respond to requests and being very bureaucratic in their approach.

The skilled clinical trials manager learns when to insist on strict compliance with the rules and when to bend, when to take one’s time and when to rush headlong, and when to stick and when to compromise in contract negotiations. It is not an easy task. In the UK we seem to have plenty of people who have these skills, and a thriving eco-system of life-science companies, service providers, hospitals, universities and regulators.

Whether this eco-system will survive Brexit is yet to be seen. There is a real danger of damage to the lagoon, its coral reef and its colourful species of fish.

 

 

Leave a comment

Filed under Contract drafting, Legal practice

10 points to look for in a draft agreement

What is it about lists that makes them popular? Over the years, this blog has created a few lists, and this golden oldie from 2015 is one of them.

IP Draughts

once overYou are sent a draft agreement and asked to review it. No other instructions are given. You are expected to know what the client wants, without asking. In the case of technology-related agreements, perhaps they think you don’t need to know the subject-matter, or that you wouldn’t understand it.

Some people are willing to go along with this, and to advise as a ‘paper exercise’ without knowing anything about the subject-matter of the deal, what commercial discussions have already taken place, what are the client’s objectives and priorities, and so on.

IP Draughts is very reluctant to advise on this basis.

In IP Draughts’ experience, digging into the details and discussing the project with the client’s representative is usually essential, and is always efficient, if the agreement is to be well-drafted and protect the client’s interests. Persistence is sometimes required to coax useful instructions out of a client who may…

View original post 1,286 more words

Leave a comment

Filed under Uncategorized

Why do organisations ignore their contractual obligations?

Last night, a contract lawyer asked on Twitter:

Various people, including IP Draughts, came up with suggestions. The most depressing was this one from another lawyer who is prominent on Twitter, @LegalBizzle, who wrote: “All of them. Not even joking.”

Why do lawyers and commercial executives spend large amounts of time and emotional energy negotiating detailed contract terms, only for their operational colleagues to ignore them?

It so happens that IP Draughts has encountered this issue most often in IT contracts between large organisations. The contract specifies a procedure, e.g. on how to escalate or resolve a dispute over performance. The operational teams of both parties work to a completely different procedure, or to none. There are plenty of email communications but none that clearly identifies what the issue is, when it was first identified, what action is expected and when the issue must be resolved. No-one, it seems, is using the contract as an operational manual.

If and when the dispute reaches the attention of the parties’ lawyers, they may reach for the contract and taken into account its procedures when communicating with the other party. Or they may just resort to bluster and, again, ignore the terms of the contract.

If the dispute ever gets to court, the parties’ advocates and witnesses will likely be forced to justify their actions through the prism of the contract terms. The judge is likely to use those terms as the starting point for determining whether the contract has been performed.

In other words, as the dispute becomes more and more “legal”, the terms of the contract will come into sharp focus. But at an operational level, there may be much less interest in what the contract actually says.

Why is this? Several theories occur to IP Draughts:

  1. The contract is off-putting to the operational managers in its style and content, and too difficult for them to use. If this is the only reason, then senior management and the legal department are to blame for not providing simple, user-friendly procedures, based on the contract, for them to use, and periodically reinforcing the message that they must follow these procedures.
  2. Nobody in the company, including the senior managers, cares what the contract says. Perhaps the in-house lawyers care, but they don’t have much influence. Perhaps all that senior management cares about is revenue-generation, and contract terms are regarded as something remote, like an insurance policy: recognised as important in principle, but not really cared about in practice. It is not difficult to decide who is to blame in this scenario for the failure to follow the contract’s procedures.
  3. The operational and commercial managers are temperamentally incapable of following detailed written procedures as set out in the contract. If this is the case, they need a process manager (who could be a lawyer, but need not be) to keep them on the straight and narrow. But perhaps senior management doesn’t realise or recognise that such a person is needed.
  4. Team dynamics result in a different way of working. The operational teams of both parties work together during the implementation of a project, and they get used to working in a particular way, that may or may not bear any resemblance to how their colleagues responsible for negotiating the contract have agreed that they will work. In this case, either they need guidance on how they should work in compliance with the terms of the contract, or the parties negotiating the contract should have taken account of the operational work-process when agreeing the contract terms. Either way, there has been poor communication within the company.

Why does any of this matter? As long as the project is working well, perhaps it doesn’t. But contracts are partly there to govern the parties’ conduct if the project isn’t working well, and to determine whether one party is liable to the other for breach of contract. Having a mis-match between how the parties behave and how they are supposed to behave, as laid down in the contract, can make it very difficult to advise on contractual rights and remedies.

This topic also reminds IP Draughts that many contracts are far too long and complex, and this fact reduces the likelihood of their being used at an operational level. An extreme example that came across IP Draughts’ desk last week was a government contract that included large numbers of clauses that seemed to be cut-and-pasted from a clause bank, as well as cross-references to the identifying names and numbers of dozens of standard government contract terms. It is easy to dismiss this as the approach of a government bureacracy, but IP Draughts has seen plenty of examples of B2B contracts that are far too long and complex.

Occasionally, IP Draughts comes across organisations that have taken a conscious decisions to simplify both the language and content of their standard contracts. He applauds such decisions and wishes more organisations, including governments, would take this approach.

If this could be combined with a determination on the part of senior management that contract terms should either be followed at an operational level, or if this is not workable the terms should be scrapped, the whole process of negotiating, and operating under, contracts would become much more streamlined and efficient.

 

2 Comments

Filed under General Commercial