HUMAN MATERIALS. The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.
HUMAN MATERIALS. Site shall comply with Law in the collection, storage, and transfer of any samples or other human materials taken from Subjects, and shall obtain any consents required from Subjects for the use of such materials in accordance with the Proto- col. Site shall only use such materials in con- nection with the Trial and in a manner con- sistent with such consents, the Protocol and Law.
HUMAN MATERIALS. The acquisition and supply of all human specimen material (including fetal material) used under this Agreement shall be obtained by Subcontractor in full compliance with applicable Federal, State and Local laws and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material. The Subcontractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this Agreement, by collaborating sites, or by lower tier Subcontractors identified under this Agreement, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects. This restriction applies to all collaborating sites without OHRP-approved Assurances, whether domestic or foreign, and compliance must be ensured by the Subcontractor. Provision by the Subcontractor to AstraZeneca of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required. The human subject certification can be met by submission of a self-designated form provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/ Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310).
HUMAN MATERIALS. To the extent a Party holds and controls Human Materials that have been collected as part of any Clinical Trial in relation to the Product or a product identical to the Product, upon the other Party's reasonable request for access to such Human Materials for purposes of obtaining Marketing Authorization Approval or other Development purposes for, in the case of Pfizer, the Product or, in the case of BioNTech, a product identical to the Product in the Fosun Territory, the Parties shall negotiate in good faith with respect to an agreement under which the Party holding and controlling such Human Materials could provide such Human Materials.
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 for the activities under the Research Plan, each Party represents and warrants, as to any such activities conducted by such Party (a) that it has complied, and shall comply, with all Applicable Law relating to the collection or use of the Human Materials and (b) that it has obtained, and shall obtain, all necessary approvals and appropriate informed consents, in writing, for the collection and use of such Human Materials.
HUMAN MATERIALS. 14 ARTICLE H.4. CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH................................ 15 ARTICLE H.5. NEEDLE EXCHANGE.................................................................. 15 ARTICLE H.6. PRIVACY ACT...................................................................... 15 ARTICLE H.7. SUBCONTRACTING PROVISIONS........................................................ 15 ARTICLE H.8. SALARY RATE LIMITATION LEGISLATION PROVISIONS.................................... 16 ARTICLE H.9.
HUMAN MATERIALS. If, with respect to any Study conducted hereunder, human materials will be collected from Study Subjects, stored by Institute and transferred to Company or other third parties, Institute shall comply with Applicable Law in the collection, storage, and transfer of such human materials and Institute shall ensure that the Informed Consent describes such collection, storage and transfer. Any use of such human materials by a Party, whether in the course of conducting the Study hereunder or otherwise, shall be consistent with the terms of the applicable Informed Consents and Applicable Law.
