Mercene Labs General Disclaimer
Unless Mercene Labs specifically and expressly contracts in writing with the customer for a particular intended use of our product, the choice of our product for any particular intended use is the sole and exclusive responsibility of the customer; and Mercene Labs shall in no event ever have any responsibility for, nor incur any liability for any particular use or application of its product by the customer absent such a specific and express written contractual agreement otherwise.
Mercene Labs CAUTION Regarding Medical Applications of Mercene Labs Materials
UNLESS OTHERWISE EXPLICITLY SPECIFIED IN CURRENT, APPLICABLE MERCENE LABS PRODUCT DATA SHEETS OR APPLICATIONS LITERATURE, MERCENE LABS MAKES NO CLAIM THAT ITS MATERIALS ARE CERTIFIED BIO-COMPATIBLE OR OTHERWISE INTENDED FOR USE IN ANY MEDICAL DEVICE OR OTHER MEDICAL PRODUCT. WITHOUT LIMITING THE GENERALITY OF THE FOREGOING: DO NOT USE MERCENE LABS PRODUCTS OR MATERIALS IN ANY MEDICAL APPLICATIONS INVOLVING IMPLANTATION IN THE HUMAN BODY OR ANY ANIMALS, OR CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES UNLESS THE SAME HAS BEEN PROVIDED BY MERCENE LABS UNDER A WRITTEN CONTRACT THAT IS CONSISTENT WITH THE MERCENE LABS POLICY REGARDING MEDICAL APPLICATIONS, AND MERCENE LABS SPECIFICALLY AND EXPRESSLY ACKNOWLEDGES AND AGREES TO THE CUSTOMER’S PARTICULAR CONTEMPLATED USE. OTHERWISE, MERCENE LABS MATERIALS ARE NOT DESIGNED OR MANUFACTURED FOR ANY SUCH USE.
MICROCHEM MAKES NO REPRESENTATION, PROMISE, EXPRESS WARRANTY OR IMPLIED WARRANTY CONCERNING THE SUITABILITY OF THESE MATERIALS FOR ANY MEDICAL USE INCLUDING, WITHOUT LIMITATION, IMPLANTATION IN THE HUMAN BODY OR ANY ANIMALS, OR CONTACT WITH INTERNAL BODY FLUIDS OR TISSUES.
MERCENE LABS MATERIALS ARE NOT CERTIFIED FOR IMPLANTS. Mercene Labs has not performed clinical testing of any of its materials. Mercene Labs will not provide customers making implantable devices any notice concerning its materials, as specified under United States Code of Federal Regulations 21 C.F.R. section 820.50, or any other information necessary for medical-device use of the materials under any other statute or FDA or other regulation. Mercene Labs has neither sought, nor received, approval from the FDA or any other governmental agency for the use of these materials in implantation in the human body or any animals, or in contact with internal body fluids or tissues.
DO NOT MAKE REFERENCE TO THE MERCENE LABS NAME OR ANY MERCENE LABS TRADEMARK IN ASSOCIATION WITH AN IMPLANTABLE MEDICAL DEVICE. Do not use a Mercene Labs trademark as the descriptive name of an implantable medical device.
ALL MEDICAL DEVICES, INCLUDING IMPLANTABLE MEDICAL DEVICES, CARRY A RISK OF FAILURE AND ADVERSE CONSEQUENCES. Regarding implantation of materials, you should rely upon the medical judgment of the physician, the medical device seller and the FDA. Do not rely upon Mercene Labs in any medical matters including, without limitation, implantation. Examples of both harmful consequences and life-saving benefits from the implantation of various materials can be found in published medical articles. Mercene Labs does not perform clinical medical studies of any implantable medical devices. Mercene Labs cannot weigh the benefits against the risks of a device, nor can it offer a medical judgment on the safety or efficacy of the use of our material in a medical device of any kind or nature.
In order to manage business risk in this area Mercene Labs will not supply Mercene Labs materials in the ordinary course of business to firms using such materials for medical applications involving permanent implantation in the human body or in any animals (other than laboratory animals used for experimental purposes). There are exceptions to this rule where Mercene Labs has expressly contracted with a customer for a specifically identified application, which Mercene Labs will do when, in its own discretion and business judgment, the business-risk-management strategies are adequate to justify a supplier/customer relationship.