“Existing Data” means with respect to a Product, those pre–clinical and clinical vaccine development activities that are necessary or useful to obtain Marketing Approval, from at least one Approved Regulatory Authority and in applicable regulatory jurisdictions including stability testing, toxicology, formulation and process development, CMC development, manufacturing process validation, statistical analysis, pre–clinical and clinical studies, regulatory filing submissions and approval, pharmacoviligance and postmarketing commitments and that exist as at the Effective Date.
“Material” means any chemical or biological substance used in or created, devised or generated during the Project including any: i. organic or inorganic element; ii. nucleotide or nucleotide sequence including DNA and RNA sequences; iii. gene; iv. vector or construct including plasmids, phages or viruses; v. host organism including bacteria, fungi, algae, protozoa and hybridomas; vi. eukaryotic or prokaryotic cell line or expression system or any development strain or product of that cell line or expression system; vii. protein including any peptide or amino acid sequence, enzyme, antibody or protein conferring targeting properties and any fragment of a protein or a peptide enzyme or antibody; viii. drug or pro–drug including bulk drug substance, filled product and any manufacturing intermediates; ix. assay or reagent; x. any other genetic or biological material or micro–organism; xi. transgenic animals; and xii. clinical samples.
14. Warranties and Liability
14.1 Warranties. As at the Effective Date, and at the submission of each Milestone Report to FUNDER, the Partner warrants to FUNDER (subject to any matters fairly and accurately disclosed in the Disclosure Letter (if any)) that:
14.1.1. it has the requisite authority to enter into this Agreement;
14.1.2. it has full power and authority to assume all of its obligations under this Agreement; and
14.1.3. to the best of its knowledge and belief it is the legal and beneficial owner of all right, title and interest in and to the Background Intellectual Property, the Existing Data and the Material;
14.1.4. it has not granted any third party any right in respect of any Project Inventions, Data, Material or Foreground Intellectual Property (other than in accordance with the terms of this Agreement), and has not charged or encumbered any of the same;
14.1.5. save as disclosed in the Disclosure Letter, to the best of its knowledge and belief, the Background Intellectual Property and Foreground Intellectual Property are not subject to any claim, opposition, attack, assertion or other arrangements of whatever nature which may impugn upon the use, validity, enforceability or ownership of any such Intellectual Property, and there are no grounds or other circumstances which may give rise to the same;
14.1.6. it has not itself or through any of its staff, collaborators or sub–contractors, disclosed to any third party (other than under appropriate confidentiality obligations) any Confidential Information relating to the Project, nor is it obliged so to do;
14.1.7. to the best of its knowledge and belief, no person has the right to call for the assignment of, grant of a licence to it of or the right to any charge or encumbrance over any Background Intellectual Property, Data, Materials or Foreground Intellectual Property under any option, grant or other agreement, nor is there any conditional or unconditional agreement or circumstance whereby such a right may arise;
14.1.8. to the best of its knowledge and belief, no person has any right or claim to any payment or other compensation in respect of the use or exploitation of the Background Intellectual Property, Existing Date, Data, Materials or the Foreground Intellectual Property;
14.1.9. all activities performed in the Development Plan/Project have been performed in accordance with all applicable laws, regulations and standards including GCP, GLP, GMP and the UK Bribery Act 2010 and FUNDER Policies where applicable;
14.1.10. the Partner is the sponsor of all Clinical Trials from which Data was obtained;
14.1.11. the Partner has disclosed to FUNDER all adverse information with respect to the safety and efficacy of the Product;
14.1.12. the Partner has disclosed to FUNDER all material communications with Regulatory Authorities; any Ethical Committee refusal to grant approval for a Clinical Trial, any suspension of the Clinical Trial, whether initiated by the sponsor, an Ethical Committee, a Regulatory Authority or an investigator, any action or recommendation of a data safety monitoring board to suspend the Clinical Trial, and all findings of any audit for the Clinical Trial for compliance with GCP;
14.1.13. none of the Partner, its Affiliates, collaborators and sub–contractors nor any officer or employee of the Partners, its Affiliates, collaborators or sub– contractors has been debarred or is subject to debarment by a Regulatory Authority anywhere;
14.1.14. all Escrow Materials required to be placed into escrow in accordance with development–partnering–agreement–8/” target=”_blank” rel=”noopener“>Clause 9.4 have been; and
14.1.15. all Financial Documents were true, complete and accurate at the date of such document.
14.2. Except as expressly provided in this Agreement, neither Party gives any warranties or makes any representations with respect to any of the Foreground Intellectual Property, the Background Intellectual Property or any products derived from them, or their fitness for any purpose, or that any material produced or supplied by either Party and any processes or techniques used, proposed or recommended by either Party will not infringe any patent or other Intellectual Property rights of any person in any country.