1.61 “Examined Party” has the meaning set forth in Section 10.11 (Financial Records and Audits).
1.62 “Executive Officers” has the meaning set forth in Section 3.7.3 (Decisions of the JSC).
1.63 “Exploit” means to make, have made, use, import, export, offer to sell, sell, Develop, Manufacture, perform Medical Affairs activities, Commercialize, or otherwise exploit. “Exploitation” will be construed accordingly.
1.64 “FD&C Act” means the United States Federal Food, Drug and Cosmetic Act, as amended from time to time, together with any rules, regulations, and requirements promulgated thereunder (including all additions, supplements, extensions, and modifications thereto).
1.65 “FDA” means the United States Food and Drug Administration or any successor entity thereto having essentially the same function.
1.66 “Field” means the treatment, palliation, or prevention of all indications, diseases, and disorders in [***] humans.
1.67 “First Commercial Sale” means, with respect to any Licensed Product [***] (as applicable) in any country or region, the first sale for monetary value of such Licensed Product [***] (as applicable) to a Third Party for distribution, use, or consumption in such country or region after receipt of Regulatory Approval for such Licensed Product in such country or region. First Commercial Sale excludes [***].
1.68 “Force Majeure” has the meaning set forth in Section 17.3 (Force Majeure).
1.69 “FTE” means the equivalent of the work of one duly qualified employee of a Party full time for one year (consisting of a total of [***] hours per year) carrying out Development, Manufacturing, Medical Affairs activities, or other scientific or technical work under this Agreement. [***]
1.70 “FTE Rate” means the amount for an FTE per Calendar Year, which for the Calendar Year ending on [***] will be (a) with respect to ImmunoGen, [***] per FTE; and (b) with respect to Partner, [***] per FTE, in each case, pro-rated for the period beginning on the Effective Date and ending on [***]. Beginning on [***] and on [***] of each subsequent Calendar Year during the Term, [***].
1.71 “Fully Burdened Manufacturing Cost” means, with respect to any Licensed Product, in each case, supplied by or on behalf of the applicable Party to the other Party or its Affiliates hereunder:
(a) if and to the extent such Licensed Product (or any precursor or intermediate thereof), as applicable, [***], (i) [***], (collectively “Cost Per Vial”) plus (ii) [***]; or
(b) if and to the extent such Licensed Product (or any precursor or intermediate thereof), as applicable, [***], the actual, fully burdened costs that are attributable to and reasonably allocated to such Manufacturing, [***].
1.72 “GAAP” means United States generally accepted accounting principles, consistently applied.
1.73 “GCP” means all applicable good clinical practice standards for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of Clinical Trials, including, as applicable