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Source: ARTARA THERAPEUTICS, INC., 8-K, 1/10/2020
1.2 "CRO" means a contract research organization selected by ArTara to assist in the Project as approved by the University and/or Principal Investigator, such approval not to be unreasonably delayed or withheld. 1.3 "FDA" means the United States Food and Drug Administration. 1.4 "Field" means all therapeutic, diagnostic and prophylactic uses of the Product(s). 1.5 "First Commercial Sale" means the first sale for use or consumption for which revenue has been recognized of Product in a country or territory after all required Regulatory Approvals for commercial sale of Product have been obtained in such country or territory. 1.6 "ICH-GCP's" means the International Conference on Harmonization and Good Clinical Practice Guidelines as adopted in the applicable FDA regulations. 1.7 "Indication" means treatment of lymphangioma (also known as lymphatic malformations) in humans. 1.8 "IND" means University filed investigational new drug application on file with the FDA (BB-IND#5266) for OK-432 for the Indication. 1.9 "Net Sales" means, with respect to the Product, the gross invoiced sales price payable to ArTara and/or its Affiliates and their respective licensees and sublicensees for sales anywhere in the world of the Product to a third party, less: (a) discounts (including cash, quantity and patient program discounts), retroactive price reductions, charge-back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies, and purchasers and reimbursers or to trade customers; (b) credits or allowances actually, not to exceed the original invoice amount, granted upon claims, damaged goods, rejections or returns of the Product, including the Product returned in connection with recalls or withdrawals; (c) freight out, postage, shipping and insurance charges for delivery of the Product if charged separately and include in the gross receipts; and (d) taxes or duties, excluding income taxes and value-added taxes, levied on, absorbed or otherwise imposed on the sale of the Product, including governmental charges otherwise imposed upon the billed amount, as adjusted for rebates and refunds, provided that such are included in gross receipts and are paid to and/or its Affiliates and their respective licensees and sublicensees.
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Source: ARTARA THERAPEUTICS, INC., 8-K, 1/10/2020