REGULATORY RESPONSIBILITY: In the course of developing the testing protocol, Nelson Laboratories provides Sponsor with options and alternatives for testing, but does not assume the Sponsor’s responsibility for determining the suitability of testing for:
(1) the Sponsor’s use; or
(2) meeting applicable regulatory requirements. By signing this approval the sponsor accepts Nelson Laboratories’ offer to perform testing as described herein. Sponsor further acknowledges that they have (1) assessed the suitability of the testing relative to their product; and (2) assessed any regulatory requirements related to the testing of their product.
TEST AND CONTROL ARTICLE CHARACTERIZATION: The sponsor is responsible for test/control article characterization. This includes, but is not limited to, identity, strength, purity, and stability. Nelson Laboratories makes no warranties about the representative nature of the test/control article submitted by the study sponsor. 21 CFR Part 58 Subpart F Sec 58.105, 16 CFR Part 160 Subpart F Sec 160.105
SAMPLE RETENTION: Nelson Labs does not retain samples after testing unless otherwise negotiated. Samples will be discarded or returned as specified on the Sample Submission Form.
INTELLECTUAL PROPERTY: All reports and letters issued by Nelson Laboratories, LLC, are for the exclusive use of the sponsor to whom they are addressed. Reports or protocols may not be reproduced except in their entirety. No quotations from reports or use of the corporate name, “Nelson Laboratories, LLC,” is permitted except as expressly authorized by Nelson Laboratories, LLC, in writing. Protocols are the intellectual property of Nelson Laboratories, LLC Protocols are issued to our customers for review and input into the services that we provide. However, issuance and/or billing for a protocol does not indicate a transfer of ownership of intellectual property owned by Nelson Laboratories, LLC.
SAMPLE ADEQUACY: The significance of any data is subject to the adequacy and representative character of the samples tendered for testing. Nelson Laboratories, LLC, warrants that all tests are performed in accordance with established laboratory procedures and standards. Nelson Laboratories, LLC makes no other warranties of any kind, express or implied.
LIMITS OF LIABILITY: Nelson Laboratories, LLC, expressly states that it makes no representation or warranty regarding the adequacy of the samples tendered for testing for any specific use or application, that determination being the sole responsibility of the sponsor. Nelson Laboratories’ liability for any loss or damage resulting from its actions or failure to act shall not exceed the cost of tests performed, and it shall not be liable for any incidental or consequential damages.
DOCUMENTATION: All test procedures, final reports and other auxiliary documentation on file that Nelson Laboratories utilized for performing the testing identified in this protocol will contain sufficient detail to ensure reproducibility of results from test interval to test interval as well as at other labs if required.