Development will precede and condition the marketing of the product.

The purpose of the contract will therefore be to determine the division of roles between the customer and the service provider, to specify the objective expected by the parties and the material and financial conditions for carrying out the development operations.

The project may involve a new product, a new process, or an adaptation of an existing product.

In most cases, the aim will be to develop a new medicine with stability studies and validation batches, but the degree of innovation may vary from one project to another (new treatment, new galenic form, new delivery method, or extension of the range of a medicine already on the market).

In other words, the development contract will not meet the same legal requirements depending on the precise context in which it will be used, and in practice the term "development contract" covers a wide range of situations that can be very different from one another.

We will, of course, start from a common base, namely the fact that, from a legal point of view, this is a contract for the provision of services subject - and this is essential - to an obligation de moyens1 (obligation of means or conduct) on the part of the service provider, given the uncertainty (which varies according to the type of project envisaged) and the risk associated with the development.

From a legal point of view, what reflexes should you adopt when negotiating a development contract?