RTP Company Policy Regarding Medical Applications

  1. As a custom compounder, RTP Company manufactures specialty compounds which are suitable for use in a wide variety of articles and industries. Among other things, RTP Company does business with customers whose products may be implanted in the human body or come into contact with bodily fluids or tissues. RTP Company refers to such uses as “Bodily Contact Medical Applications.” None of RTP Company’s compounds have been determined by RTP Company, any governmental agency such as the U.S. Food and Drug Administration, or any scientific agency as safe to use in articles to be implanted in the human body or in contact with bodily fluids or tissues. As a result, persons proposing to use RTP Company materials in Bodily Contact Medical Applications must rely on their own technical, legal, and medical judgment without reliance on any representation by RTP Company.
  2. For purposes of RTP Company’s policies, there are three types of Bodily Contact Medical Applications depending on how long the product may be implanted into the human body or be in contact with bodily fluids or tissues: Permanent (30 days or more), Temporary (more than 24 hours but less than 30 days), and Transient (24 hours or less). RTP Company’s terms and conditions concerning products used in Bodily Contact Medical Applications depend on whether the Bodily Contact Medical Applications are Permanent, Temporary, or Transient.
  3. Permanent Bodily Contact Medical Applications: RTP Company does not provide materials for use in any articles to be implanted in the human body for 30 days or more, or to be in contact with internal bodily fluids or tissues for 30 days or more. ANY SUCH USE IS WITHOUT RTP COMPANY’S CONSENT AND VOIDS ANY WARRANTIES OR CONTRACTUAL OBLIGATIONS OF RTP COMPANY WHICH OTHERWISE MAY APPLY. RTP COMPANY MAKES NO WARRANTY, PROMISE, OR REPRESENTATION WHATSOEVER WITH RESPECT TO ANY OF ITS MATERIALS THAT MAY BE USED IN PERMANENT BODILY CONTACT MEDICAL APPLICATIONS AND DISCLAIMS ALL LIABILITY FOR ANY LOSS OR DAMAGE IN ANY WAY ARISING OUT OF OR RELATING TO SUCH USE OF ITS MATERIALS.
  4. Temporary Bodily Contact Medical Applications: RTP Company may support certain Temporary Bodily Contact Medical Applications based on the particular circumstances of each situation. Customers proposing to use RTP Company materials in Temporary Bodily Contact Medical Applications must disclose the particular circumstances of the proposed use to the RTP Company sales engineer or other product representative with whom they are working via the RTP Company Medical Questionnaire. RTP Company will review the proposed use. If RTP Company determines to support the proposed Temporary Bodily Contact Medical Application, the customer will be required to sign RTP Company’s standard Disclaimer and Hold Harmless Agreement for Temporary Bodily Contact Medical Applications. Provided that the customer signs the Disclaimer and Hold Harmless Agreement and the Disclaimer and Hold Harmless Agreement is approved and accepted by RTP Company as indicated by the document being signed by an authorized representative of RTP Company, the standard RTP Company product warranty will apply: RTP Company will warrant the materials to be free from defects in material and workmanship. However, if RTP Company determines not to support the proposed Temporary Bodily Contact Medical Application or the customer fails to sign the Disclaimer and Hold Harmless Agreement, SUCH USE IS WITHOUT RTP COMPANY’S CONSENT AND VOIDS ANY CONTRACTUAL OBLIGATIONS OF RTP COMPANY WHICH OTHERWISE MAY APPLY. RTP COMPANY MAKES NO WARRANTY, PROMISE, OR REPRESENTATION WHATSOEVER WITH RESPECT TO ANY OF ITS MATERIALS THAT MAY BE USED IN TEMPORARY BODILY CONTACT MEDICAL APPLICATIONS WITHOUT A FULLY EXECUTED DISCLAIMER AND HOLD HARMLESS AGREEMENT AND DISCLAIMS ALL LIABILITY FOR ANY LOSS OR DAMAGE IN ANY WAY ARISING OUT OF OR RELATING TO SUCH USE OF ITS MATERIALS.
  5. Transient Bodily Contact Medical Applications: RTP Company may grant consent for Transient Bodily Contact Medical Applications if RTP Company receives a completed RTP Company issued Medical Questionnaire and RTP Company assigns medical product nomenclature to the application. If these conditions are satisfied, RTP Company’s standard product warranty will apply: RTP Company will warrant the materials to be free from defects in material and workmanship. No other warranties are applicable. However, if these conditions are not satisfied, SUCH USE IS WITHOUT RTP COMPANY’S CONSENT AND VOIDS ANY CONTRACTUAL OBLIGATIONS OF RTP COMPANY WHICH OTHERWISE MAY APPLY.

Revised July, 2019