Provision Language
12. Compliance with Law
12.1. Mutual Representations and Warranties. Each Party represents and warrants that it will comply with all applicable laws and regulations, including without limitation those governing conflict of interest, human research, animal research, and export control. Each Party shall reasonably cooperate with the other to identify and manage any export–controlled technology used in meeting its obligations hereunder. Where the clinical trial is to be undertaken under this Agreement, Afrigen shall comply with ICH GCP principles outlined in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Good Clinical Practice guidelines as laid down in the “ICH Topic E6(R1)” and set out at http://www.ich.org/products/guidelines/efficacy/article/efficacy–guidelines.html, as amended from time to time. Afrigen shall notify MPP immediately (within 24 hours) in case of any issues regarding compliance with the rules set out this Section 11.1.
12.2 Animal welfare. Afrigen shall procure that any research under the Project that involves animals that is undertaken by Afrigen, or their partners, collaborators or service providers (whether in the South Africa or internationally) shall comply with the UK Animals (Scientific Procedures) Act 1986, to be approved by the local ethical review process and be conducted with due consideration for the 3Rs (replacement, reduction and refinement of the use of animals in research). Afrigen shall notify MPP immediately (within 24 hours) in case of any issues regarding compliance with the rules set out this Section 11.2.
12.3 Afrigen Further Representations and Warranties. Afrigen further represents and warrants that: (a) it has established policies and procedures to ensure compliance with all applicable laws and regulations pertaining to the conduct of research in humans; (b) that neither it nor its principals are presently debarred, suspended, proposed for debarment, declared ineligible, or voluntarily excluded from participation in this transaction by any governmental department or agency; (c) it has reviewed and agreed with the specific donors’ requirements, set out in the Attachment 3 hereto and (d) all personnel working on the Project, including Key Personnel, have met all legal and organizational requirements to perform the work anticipated hereunder with the appropriate level of skill required therefor.
12.4. Disclaimer. EXCEPT AS PROVIDED IN SECTIONS 11.1 AND 11.2, NEITHER PARTY MAKES ANY A EACH EXPRESSLY DISCLAIMS ALL REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, REGARDING ITS PERFORMANCE UNDER THIS AGREEMENT, INCLUDING WITHOUT MARKETABILITY, USE OR FITNESS OF THE RESULTS DEVELOPED HEREUNDER FOR ANY PARTICULAR PURPOSE.