1.52 “Jointly Owned Patent” means any Patent (a) claiming bothKnow-How solely owned by Company or any of its Subsidiaries andKnow-How solely owned by DESRES or any of its Subsidiaries, and/or (b) claimingKnow-How jointly owned by Company or any of its Subsidiaries and by DESRES or any of its Subsidiaries.
1.53 “Know-How” means all commercial, technical, scientific or otherknow-how, information, inventions, trade secrets, knowledge, technology, methods, processes, practices, formulae, mathematical techniques, instructions, skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs, algorithms, specifications, data and results (including biological, chemical, pharmacological, toxicological, pharmaceutical, physical and analytical, preclinical, clinical, safety, manufacturing and quality control data andknow-how, including regulatory data, study designs and protocols), in all cases, whether or not patented or patentable, in written, electronic, oral or any other form now known or hereafter developed.
1.54 “Marketing Authorization Application” or “MAA” means an application for Regulatory Approval in a country, territory or possession, including an NDA.
1.55 “NDA” means a New Drug Application, as defined in the FD&C Act and in applicable regulations promulgated thereunder by the FDA.
1.56“Net Sales” means the gross amount invoiced by or on behalf of Company or any of its Subsidiaries or any Rights-Holding Party for sales or other transfers of any unit of a Category 1 Product to a Third Party (“Gross Sales”), less the following with respect to the sale of the relevant unit of such Category 1 Product to the extent included in Gross Sales:
(a) customary trade, quantity or cash discounts to the extent actually allowed and taken;
(b) amounts repaid or credited by reason of defects, recalls, rejections or returns;
(c) to the extent separately stated on purchase orders, invoices or other documents of sale, any taxes or other governmental charges levied on the sale, transportation, delivery or use of such Category 1 Product which are paid by or on behalf of Company, but excluding any taxes on net income;
(d) outbound transportation costs prepaid or allowed and costs of insurance in transit, to the extent separately stated on purchase orders, invoices or other documents of sale;
(e) rebates and chargebacks to customers and Third Parties (including Medicare, Medicaid, managed healthcare and similar types of rebates) granted and taken in the ordinary course of business or as required by Applicable Law; and
(f) delayed ship order credits or discounts.
For the avoidance of doubt, the following will not be considered Net Sales hereunder: (x) [***]; (y) [***]; and (z) [***].
10