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Product Procurement and Data Licensing Contract Review and Negotiation

At Meade Roach & Annulis, our team of attorneys has extensive experience in reviewing and negotiating contracts for the sale and purchase of medical devices, medical supplies and pharmaceuticals.  We understand the unique legal issues which face both sellers and purchasers of medical devices, medical supplies and pharmaceutical drugs.  Whether it is:

  • negotiating your indemnification rights and obligations;

  • addressing your protections and responsibilities in the event of an FDA initiated mandatory recall or a manufacturer initiated recall;

  • protecting your confidential information and trade secrets from unauthorized disclosure to third parties;

  • negotiating representations and warranties relating to the products manufacturing and labeling being in compliance with applicable laws, including the Federal Food, Drug and Cosmetic Act of 1938, as amended, and FDA approved Good Manufacturing Practices;

  • structuring rebates so as to be in compliance with both federal and state anti-kickback laws and regulations; or

  • addressing your rights and responsibilities in the event of  failure to supply for any reason,

we are here to offer legal guidance and advice on how to handle and protect your interests in the event any such issues occur.  Regardless of whether you are a seller or purchaser of medical devices, medical supplies or pharmaceuticals it is essential that you have agreements which address the issues your business may face in order to protect your legal and economic interests.  We have represented sellers and purchasers in an array of industries including a major dialysis provider, a teleradiology provider, hospitals, and a mail order diabetic supplier.

Our team of attorneys also has significant experience in structuring arrangements for the licensing and sale of clinical data to study sponsors, academic institutions, medical device manufacturers, and pharmaceutical suppliers.  It is critical that these arrangements be structured to comply with HIPAA and its attendant regulations, including issues related to whether the clinical data will be delivered as part of a limited data set or be delivered as de-identified patient information.  In addition, it is important to address issues relating to how a licensee may use and disclose the clinical data which is licensed.  Any agreement for the sale or licensing of clinical data must also ensure that the consideration received for such data does not violate the federal anti-kickback statute or any state anti-kickback statute.  No matter what your issue might be in arranging a sale or license of your proprietary clinical data, our team of attorneys has the knowledge and experience to guide you through the process and address the potential legal issues you might encounter.