With respect to any sale of any Product in a given country for less than fair market value or for any substantive consideration other than monetary consideration on arm’s length terms (which has the effect of reducing the invoiced amount below what it would have been in the absence of such non-monetary consideration), for purposes of calculating the Net Sales under this Agreement, such Product shall be deemed to be sold exclusively for cash at the average Net Sales price charged to Third Parties for cash sales in such country during the applicable reporting period (or if there were only de minimis cash sales in such country, at the fair market value as determined in good faith based on pricing in comparable markets).
1.22 “Patent Rights” means all patents and patent applications (which for the purpose of this Agreement shall be deemed to include certificates of invention and applications for certificates of invention), including all divisionals, continuations, substitutions, continuations-in- part, re-examinations, reissues, additions, renewals, revalidations, extensions, registrations, pediatric exclusivity periods and supplemental protection certificates and the like of any such patents and patent applications, and any and all foreign equivalents of the foregoing.
1.23 “Person” means any individual, partnership, limited liability company, firm, corporation, association, trust, unincorporated organization or other entity.
1.24 “Product” means any and all veterinary products that contain a Licensed Virus as an active ingredient, either alone or in combination of other active ingredient (provided that such other active ingredient cannot be proprietary to Licensor but is not a Licensed Virus), in any formulation, dosage form or mode of administration.
1.25 “Regulatory Approval” means all approvals from governmental authorities that are necessary for the commercial sale of the Product in a given country or regulatory jurisdiction.
1.26 “Regulatory Authority” means any applicable government authority responsible for granting Regulatory Approvals for the Product, including the FDA-CVM and USDA-CVB in the U.S. and any corresponding foreign authorities.
1.27 “Regulatory Exclusivity” means any exclusive marketing rights or data exclusivity rights (other than Patent Rights) conferred by any Regulatory Authority with respect to the Product in a given country or regulatory jurisdiction.
1.28 “Regulatory Materials” means any regulatory application, submission, notification, communication, correspondence, registration and other filings made to, received from or otherwise conducted with a Regulatory Authority in order to develop, manufacture, market, sell or otherwise commercialize the Product in a particular country or jurisdiction.
1.29 “Territory” means worldwide.
1.30 “Therapeutic Virus(es)” means virus-based cancer therapeutics, whether a virus (replicating-competent, -non-competent, or conditional replicating) by itself, or in mixture with, attached to or inside others (e.g., other virus, prokaryotic or eukaryotic cell, immune cell, microorganism, protein/peptide, nucleic acid, nanoparticle, chemotherapeutic agent, diagnostic agent, or other organic or inorganic materials). Exemplary virus-based therapeutics include oncolytic viruses (e.g., replication-competent viruses selected or engineered to preferentially infect and kill cancer cells, such as Olvi-Vec), vaccines and gene therapy products.
5.
Confidential