Common use of THE SAMPLES Clause in Contracts

THE SAMPLES. ▇. ▇▇▇▇▇▇▇▇ represents, warrants and covenants to Institution as follows: i. all Samples and related information provided to Institution pursuant to this Agreement were collected or will be collected, handled, and transferred in compliance with all applicable state, federal and foreign laws and regulations relating to protection of human research subjects, privacy and security of individually identifiable health information, and standards for notification of breaches of individually identifiable health information applicable and in effect at the time and location of the collection and transfer of such Samples or information and any applicable policies of any institutional review board, privacy board, or ethics committee with jurisdiction over the collection, handling, and transfer of such Samples or information. ii. all Samples and related information provided to Institution pursuant to this Agreement shall be provided with all direct identifiers removed in accordance with 45 C.F.R. Section 164.514(e)(2). If any Services will entail the provision to Institution of any information that is not fully de-identified in accordance with 45 C.F.R. Section 164.514(b), the corresponding Task Order shall include each of the elements of the mandatory Data Use Agreement as specified in 45 C.F.R. Section 164.514(e)(4)(ii)(A)-(C). B. Institution shall not transfer any Samples or other materials obtained or received in connection with this Agreement, or any derivatives thereof, to any third party without Novartis prior written approval. C. Institution shall use the Samples and materials obtained or received in connection with this Agreement solely for the performance of the Services in Institution’s laboratories under suitable containment conditions in accordance with all applicable laws and regulations and may make Component Improvements incidental to performing the Services. Institution shall not analyze the samples or materials other than as necessary to perform the Services. D. Upon completion of the Services under any Task Order, or upon termination of any Task Order, Institution shall return to Novartis or destroy, as requested by Novartis, any unused samples and materials obtained or received in connection with this Agreement. ▇. ▇▇▇▇▇▇▇▇ intends to use the results of the Services for uses reasonably related to the development and submission of information under a U.S. federal law that regulates that manufacture, use, or sale of drugs. The foregoing does not in any way limit any other rights or uses of the results of the Services by Novartis.

THE SAMPLES. ▇. ▇▇▇▇▇▇▇▇ A. Novartis represents, warrants and covenants to Institution as follows: i. all Samples and related information provided to Institution pursuant to this Agreement were collected or will be collected, handled, and transferred in compliance with all applicable state, federal and foreign laws and regulations relating to protection of human research subjects, privacy and security of individually identifiable health information, and standards for notification of breaches of individually identifiable health information applicable and in effect at the time and location of the collection and transfer of such Samples or information and any applicable policies of any institutional review board, privacy board, or ethics committee with jurisdiction over the collection, handling, and transfer of such Samples or information. ii. all Samples and related information provided to Institution pursuant to this Agreement shall be provided with all direct identifiers removed in accordance with 45 C.F.R. Section 164.514(e)(2). If any Services will entail the provision to Institution of any information that is not fully de-identified in accordance with 45 C.F.R. Section 164.514(b), the corresponding Task Order shall include each of the elements of the mandatory Data Use Agreement as specified in 45 C.F.R. Section 164.514(e)(4)(ii)(A)-(C). B. Institution shall not transfer any Samples or other materials obtained or received in connection with this Agreement, or any derivatives thereof, to any third party without Novartis prior written approval. C. Institution shall use the Samples and materials obtained or received in connection with this Agreement solely for the performance of the Services in Institution’s laboratories under suitable containment conditions in accordance with all applicable laws and regulations and may make Component Improvements incidental to performing the Services. Institution shall not analyze the samples or materials other than as necessary to perform the Services. D. Upon completion of the Services under any Task Order, or upon termination of any Task Order, Institution shall return to Novartis or destroy, as requested by Novartis, any unused samples and materials obtained or received in connection with this Agreement. ▇. ▇▇▇▇▇▇▇▇ E. Novartis intends to use the results of the Services for uses reasonably related to the development and submission of information under a U.S. federal law that regulates that manufacture, use, or sale of drugs. The foregoing does not in any way limit any other rights or uses of the results of the Services by Novartis.