Similarly, the consultant is often not required to report to the company on the fulfilment of the obligations described in the consulting contract. There can be no provision for the company to terminate the contract if the consultant does not provide the agreed services or does not devote the agreed time, or the company may simply fail to talk to the consultant to control the performance. In other cases, the company may have entered into an agreement with a consultant, but has never called the consultant to provide services. Tasks. According to the Safe Harbor rules, the advisor`s obligations and obligations must be clearly defined in the agreement. If it is to test devices; data collection on implanted devices; verification of IDEs, 510(k)s or other regulatory submissions; or the provision of other advisory services, the contract should expressly delineate the obligations of the adviser. In addition, the agreement should indicate the time required by the advisor monthly, quarterly or in any other regularity, and it is advisable to pay the consultant for the services provided and not in advance. Even if the advisor`s tasks are defined more narrowly, the language in an agreement can make it more difficult to monitor and evaluate an advisor`s performance. For example, “collection and maintenance of efficacy data” does not specify the form or accessibility of a database, while “verification of clinical results” does not indicate the degree of analysis or the format of verification.

According to the old proverb, an ounce of prevention is worth a pound of healing. The simple steps outlined in this article will go a long way in defending against a public inquiry into a company`s consulting agreements with its doctors/clients. While nothing is foolproof, this relatively low investment in time and resources can be largely profitable in the long run. Even if there has been an analysis of the fair value of the consultant`s services, it may be a bad analysis. Medical technology companies often use the amount of money the consultant gives up as a measure of the value of their services. So, if a surgeon generates $10,000 a day from procedures, the company uses that figure as a basis for calculating a daily or hourly fee for counseling services. It is likely that the Government will take the position that the value of the benefit granted would be the total turnover of the product or products in question to physicians with consulting contracts or to their respective institutions. Direct costs should be deducted from this total turnover in order to determine the net profits granted. Therefore, the government`s transaction offer or its position at the time of conviction will cost the company all sales generated by the consultant`s practice.

So there, you have it, the false contracture is bad. .

Thursday, October 7th, 2021


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