quality assurance, idle and stability costs, warehousing costs before shipment, labeling, and packaging, labor (including benefits), depreciation and overhead, shipping to port of US entry under CIP, all determined in accordance with GAAP.
1.12. “Distribution Fee” has the meaning set forth in Section 3.7.
1.13.“FDA” means the United States Food and Drug Administration or any successor agency which issues a Regulatory Approval for the marketing of a Product in the United States.
1.14.“FD&C Act” has the meaning set forth in Section 11.1.
1.15.“Forecast” has the meaning set forth in Section 5.1.
1.16.“Gross Profits” means an amount equal to (i) the Net Sales of a Product, minus the sum of (ii) the Cost of Goods Sold, and (iii) shipping costs from port of US entry to Lannett’s Place of Delivery.
1.17.“Initial Distribution Fee” has the meaning set forth in Section 3.7.
1.18.“Intellectual Property Rights” means all patents, copyrights, trademarks, service marks, service names, trade names, internet domain names, e-mail addresses, applications or registrations for any of the foregoing, or extensions, renewals, continuations or re-issues thereof, or amendments or modifications thereto, brandmarks, brand names, trade dress, labels, logos, know-how, show-how, technical and non-technical information, trade secrets, formulae, techniques, sketches, drawings, models, inventions, designs, specifications, processes, apparatus, equipment, databases, research, experimental work, development, pharmacology and clinical data, software programs and applications, software source documents, Third-Party licenses, and any similar type of proprietary Intellectual Property Right vesting in the owner and/or licensee thereof pursuant to the Applicable Laws of any relevant jurisdiction or under any applicable license or contract, whether now existing or hereafter created, together with all modifications, enhancements and improvements thereto.
1.19.“Loss(es)” means any and all losses, costs, damages, interests, fees or expenses, including but not limited to all reasonable attorneys’ fees, experts’ or consultants’ fees, expenses and costs.
1.20.“Minimum Safety Stock Level” has the meaning set forth in Section 5.8.
1.21.“Net Profit” means an amount equal to the Gross Profit of a Product, minus the Sales, Marketing and Distribution Allowance.
1.22.“Net Profit Split” has the meaning set forth in Section 3.8.
1.23. “Net Sales” means the aggregate gross sales proceeds billed for a Product by Lannett minus: