Use of Human Materials. If any human cell lines, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) have been or are to be collected and/or used in the Initial Research Program, RENOVIS represents and warrants (i) that it has complied, or shall comply, with all applicable laws, guidelines and regulations relating to the collection and/or use of the Human Materials and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. RENOVIS shall provide documentation of such approvals and consents upon MERCK’s request. RENOVIS further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including, without limitation, any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purposes.
Use of Human Materials. Without limiting the provisions of Section 2.16(a), if any human cell lines, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) are to be collected and/or used in an R&D Program or other activity hereunder, Moderna represents and warrants (i) that it shall comply, with all applicable Laws relating to the collection and/or use of the Human Materials and (ii) that it has obtained or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. Moderna shall provide documentation of such approvals and consents upon Merck’s request. Moderna further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.
Use of Human Materials. If any human cell lines, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) have been or are to be collected and/or used in the Research Program, Company represents and warrants: (i) that it has complied, or shall comply, with all applicable laws, guidelines and regulations relating to the collection and/or use of the Human Materials; and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. Company shall provide documentation of such approvals and consents upon Merck’s request. Company further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including, without limitation, any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.
Use of Human Materials. Without limiting the provisions of Section 5.1, if any human cell lines, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) are to be collected or used in the Internal SAV Programs, POC Programs, Additional Research Programs, Joint Development Program or Independent Additional Studies and other activities under the Internal SAV Program Plans, POC Plans, Additional Research Plans, Joint Development Plan and Budget for the applicable Program and Independent Additional Study Development Plans, the applicable Party represents and warrants (i) that it shall comply, with all applicable Laws relating to the collection and/or use of the Human Materials and (ii) that it has obtained or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection or use of such Human Materials. Each Party shall provide documentation of such approvals and consents upon the other Party’s request. The applicable Party further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.
Use of Human Materials. If any human cell lines, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) have been or are to be collected or used in the Research Program by a Party or any Affiliate or Third Party acting on such Party’s behalf, such Party represents and warrants (i) that it has complied, or shall comply, with all applicable Laws relating to the collection or use of the Human Materials and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection or use of such Human Materials. Each Party shall provide documentation of such approvals and consents to the other Party upon the other Party’s reasonable request. Each Party further represents and warrants that any such Human Materials that are used in the Research Program may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose. Notwithstanding anything to the contrary in Section 4.1, each Party shall hold in confidence all data that identifies or could be used to identify an individual (“Personal Data”), except as required or permitted under this Agreement, or to the extent necessary to be disclosed to regulatory agencies as part of the review process. In addition, notwithstanding anything to the contrary in Section 4.1, each Party shall comply with all applicable Laws with respect to the collection, use, storage, and disclosure of any Personal Data, including the U.S. Health Insurance Portability and Accountability Act (HIPAA) and the regulations promulgated thereunder. Each Party agrees to ensure that all appropriate technical and organizational measures are taken to protect Personal Data against loss, misuse, and any unauthorized, accidental, or unlawful access, disclosure, alteration, or destruction, including implementation and enforcement of administrative, technical, and physical security policies and procedures applicable to Personal Data and will not re-identify Personal Data.
Use of Human Materials. With respect to any NK cells to be used in the CAR-NK Cell process and any human cell lines, tissue, human clinical isolates or similar human-derived materials (collectively, “Human Materials”) that have been or are to be collected or used in the Research Programs, Company represents and warrants (i) that it has complied, or shall comply, with all applicable laws, guidelines and regulations relating to the collection or use of the Human Materials and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection or use of such Human Materials. Company shall provide documentation of such approvals and consents upon Merck’s request. Company further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities who contributed the Human Materials (“Providers”), including any obligations of compensation to such Providers for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.
Use of Human Materials. If any human cell lines, human tissue, human clinical isolates or similar human-derived materials (“Human Materials”) have been or are to be collected by or on behalf of a Party for use in the NP201 Research Collaboration or the Research Program, the collecting or using Party, as applicable, represents and warrants: (i) that it has complied, or shall comply, with all Laws relating to the collection and/or use of the Human Materials; and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. The collecting or using Party, as applicable, shall provide documentation of such approvals and consents upon the other Party’s request. Each Party further represents and warrants that such Human Materials collected by or on behalf of such Party may be used in the NP201 Research Collaboration or Research Program as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or use of, the Human Materials in the NP201 Research Collaboration or Research Program.
Use of Human Materials. Without limiting the provisions of Section 2.3.1, if any human cell lines, serum samples, biological samples, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) have been or are to be collected and/or used in the Transition Program (or under the NewLink Funding Agreements), NewLink represents and warrants (i) that it has complied, and shall comply, with all Applicable Laws relating to the collection and/or use of the Human Materials and (ii) that it has obtained, and shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. NewLink shall provide documentation of such approvals and consents upon Merck’s request. NewLink further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.
Use of Human Materials. Without limiting the provisions of Section 3.8.1, if any human cell lines, tissue, human clinical isolates or similar human-derived materials (the “Human Materials”) are to be collected or used in the activities hereunder or activities under a Collaboration Material Transfer Agreement, Company covenants (a) that it will comply, and will ensure that its Affiliates comply, and will use commercially reasonable efforts to ensure that its Third Party contractors comply, with all Laws relating to the collection or use of the Human Materials, and (b) that it has obtained, or will obtain, and will use commercially reasonable efforts to ensure that its Affiliates and Third Party contractors have obtained or will obtain, all necessary approvals and appropriate informed consents, in writing, for the collection or use of such Human Materials. Each party will provide documentation of such approvals and consents to the other Party upon such other Party’s request. Each Party further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose. Without limiting the foregoing, to the extent a Party (or its Affiliates or Third Party contractors) will be providing the other Party with access to Protected Health Information (“PHI”), as defined by HIPAA (or similar Law outside the United States, as applicable), about subjects in connection with any Clinical Trial under a Collaboration Program, such Party agrees, represents and warrants that it has obtained or will obtain (prior to providing such PHI access to such other Party) from each such subject an authorization in compliance with applicable Data Protection Laws sufficient to allow such Party to provide such information to such other Party for access, license and use by such other Party as set forth herein, or, to the extent applicable, waiver of authorization from an institutional review board or privacy board.
Use of Human Materials. If any human cell lines, tissue, human clinical isolates or similar human-derived materials (“Human Materials”) have been or are to be collected and/or used in the Research Programs, Sutro represents and warrants: (i) that it has complied, or shall comply, with all Applicable Laws, guidelines and regulations relating to the collection and/or use of the Human Materials; and (ii) that it has obtained, or shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and/or use of such Human Materials. Sutro shall provide documentation of such approvals and consents upon Merck’s request. Sutro further represents and warrants that such Human Materials may be used as contemplated in this Agreement without any obligations to the individuals or entities (“Providers”) who contributed the Human Materials, including any obligations of compensation to such Providers or any other Third Party for the intellectual property associated with, or commercial use of, the Human Materials for any purpose.
