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. 2 Source: ARTARA THERAPEUTICS, INC., 8-K, 1/10/2020 Net Sales shall be determined in accordance with generally accepted accounting principles, consistently applied. 1.10 "OK-432" means Picibanil (OK-432), a lyophilized mixture of group A Streptococcus pyogenes developed by Chugai and that has been approved by applicable Japanese pharmaceutical regulatory authorities for the treatment of the Indication. 1.11 "Principal Investigator" means Richard Smith, MD 1.12 "Product" shall mean TARA-002 and any similar products. 1.13 "Program" means collectively, the clinical research studies investigating the efficacy and safety of OK-432 for the Indication conducted by Principal Investigator in collaboration with multiple sites in the United States and the University expanded access program performed by Principal Investigator designed to improve the diagnosis and treatment of the Indication using OK-432. 1.14 "Program Data" means the data set forth on Exhibit A including all case reports forms, source data, and safety data in the possession of or available to University arising from the Program and any other data and information included in the