Net Sales shall not include, to the extent for no consideration, transfers or dispositions for charitable, promotional, preclinical, clinical trial or Development, or regulatory purposes. Sales of Licensed Product among Hansoh, its Affiliates, and its sublicensees, where such Licensed Product is ultimately resold by the purchaser to an unaffiliated Third Party, shall not be included in Net Sales hereunder, but the resale of such Licensed Product by such purchaser to the unaffiliated Third Party shall be included in Net Sales.
All discounts, allowances, credits, rebates and other deductions in the immediately foregoing clauses (i) through (viii) shall be fairly and equitably allocated to the sale of the Licensed Product by Hansoh, its Affiliates or sublicensees (including sublicensees of a sublicensee), such that the Licensed Product does not bear a disproportionate portion of such deductions as compared to other products.
NMPA means the National Medical Products Administration of China, and any successor thereto.
NMOSD means neuromyelitis optica spectrum of diseases.
Patents means any patents and patent applications and all substitutions, divisionals, continuations, continuation-in-parts, any patent issued with respect to any such patent applications, any reissue, reexamination, utility models or design patents, renewal or extension (including any supplementary protection certificate) of any such patent, and any confirmation patent or registration patent or patent of addition based on any such patent, and all counterparts thereof in any region or country.
Person means any individual, sole proprietorship, corporation, joint venture, limited liability company, partnership, limited partnership, limited liability partnership, trust or any other private, public or governmental entity.
Prime Rate means for any day a per annum rate of interest equal to the prime rate, as published in the Money Rates column of The Wall Street Journal, from time to time, or if for any reason such rate is no longer available, a rate equivalent to the base rate on corporate loans posted by at least percent (70%) of the ten largest U.S. banks.
Pro-Rata Portion means, with respect to a Global Study, (Territorial Enrollment / Global Enrollment) x Fully Loaded Costs of such Global Study.
Regulatory Approval means any approvals, registrations or authorizations by a Regulatory Authority, necessary for the manufacture, distribution, use, promotion, sale, marketing, development and commercialization of a pharmaceutical or biological product, including BLA, Licensed Product approvals, pricing approvals, import permits, IDLs and, in each case any supplements and amendments thereto but excluding reimbursement approvals.
Regulatory Authority means any national, regional, state or local regulatory agency, department, bureau, commission, council or other governmental entity, including the NMPA, involved in the granting of Regulatory Approval for pharmaceutical or biological products.
SMO means a site management organization.
[*] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.