Paragraph 2 Potential for return on investmentF1

details of the condition intended to be treated and a justification of the life-threatening or chronically debilitating nature of the condition, supported by scientific or medical references;

details of the costs incurred in connection with the development of the medicinal product;

details of any grants, tax incentives or other cost recovery provisions received in F3the United Kingdom or any other country in relation to the development of the medicinal product;

where the medicinal product is already authorised in F4the United Kingdom for any indication, or where the product is under investigation for one or more other indications, an explanation of, and justification for, the method that is used to apportion the development costs among the various indications;

a statement of and justification for all development costs that the applicant expects to incur after the submission of the application for a UK marketing authorisation;

a statement of and justification for all production and marketing costs that the applicant has incurred in the past and expects to incur in the first ten years that the medicinal product is authorised;

an estimate of and justification for the expected revenues from sales of the medicinal product in F5the United Kingdom and elsewhere during the first ten years that the medicinal product is authorised; and

information on the prevalence and incidence in F6the United Kingdom of the condition for which the medicinal product would be authorised at the time at which the application for an orphan marketing authorisation application is submitted.