We guarantee that our interventions will improve your US FDA regulatory postion,

provided that you implement and maintain the agreed-upon systems / procedures.

It is your responsibility to keep up with changes in industry practices and/or

regulatory requirements and make any necessary corrections, modifications, or

additions.

It is your responsibility to insure that your personnel also receive the

necessary training, at the required intervals, and that your senior management

is fully involved (and supportive) in reviewing these compliance activities.

Of course, J. E. Lincoln and Associates provides assistance in these areas as well.

If your company fulfills its responsibilies, and an issue still arrises with the

Agency regarding one of our interventions, we will assist you in meeting with

the local (SLC, UT) Resident Post, and/or in preparing your corrective

actions / responses, and/or an Action Plan / Gantt Chart, at no additional

charge to you.

If a visit to another Resident Post, a District office, or a Center, is

required, we would accompany your staff, and would not charge any fee.

However, your company would have to pay for travel (plane, auto ...),

hotel, and meals.

This guarantee would only apply to the first US FDA compliance audit after one of

our interventions addressing that particular area in question.

This guarantee applies only to issues between your company and the US FDA, not

to differences in opinion with other consultants, new hires / managment changes

(including sale of the company), or vendor or similar audits (e.g., ISO 13485 / 9001).

The specifics would be addressed in a proposal.

To our knowledge, we are unique in the industry in providing this guarantee.