“Net Sales” means the gross amount invoiced on account of sales of Licensed Product by the Licensee or any of its Affiliates or Sub-Licensees in the Territory (but not including sales between the Licensee, its Affiliates or Sub-Licensees where the Licensed Product is intended for resale and is resold to a third party on arms-length terms) less the following deductions directly relating to such sales of Licensed Product:
For purposes of this definition, the Licensed Product shall be considered “sold” and “deductions” allowed when recorded as invoiced in the Licensee’s, its Affiliate’s or Sub-Licensee’s financial statements prepared in accordance with the relevant accounting standards.
“NHS” means the National Health Service in England and Wales (or any successor organisation thereto) and the equivalent organisations in Scotland and Northern Ireland.
“Non-Exclusive Licensed Rights” means all Licensed Rights identified in Schedule 1A.
“Oncology Indications” means an Indication in the [***], each being an “Oncology Indication”.
“Parties” means CRH and the Licensee, each being a “Party”.
“Patent Costs” means any and all costs and expenses incurred by CRH in filing, prosecuting, maintaining, defending and enforcing the Licensed Patents, including official filing, prosecution, maintenance and renewal fees, patent attorney, translation, legal and other professional fees and expenses and costs and expenses associated with any opposition or interference action, in each case to the extent not reimbursed prior to the Effective Date (and as set out in Schedule 6) and/or accruing after the Effective Date (and as provided in Clause 7.2).
“Patents” means any patent applications, patents, author certificates, inventor certificates, utility models, and all foreign counterparts of them and includes all divisionals, renewals, continuations, continuations-in-part, extensions, reissues, substitutions, confirmations, registrations, revalidations and additions of or to them, as well as any Supplementary Protection Certificate, or any like form of protection.
“Phase I Trial” means a clinical trial in human patients in which a Licensed Product is administered to human subjects at multiple dose levels with the primary purpose of determining safety, metabolism, and pharmacokinetic and pharmacodynamic properties of the Licensed Product, and is consistent with 21 CFR § 312.21(a) and any microdosing clinical trial conducted pursuant to the FDA’s 2006 Guidance on Exploratory Investigational New Drugs or any equivalent arrangements. For purposes of this Agreement, any FDA approved trial designated “Phase lb/I la” will be deemed a Phase I trial provided that it does not include a control (including placebo or standard of care) arm.
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