definiens: shall mean, with respect to Product, the sum of the following, all of which shall be calculated in accordance with U.S. Generally Accepted Accounting Principles . : ( a ) The amounts paid by ANESIVA to any third party for ( i ) providing raw materials and packaging materials for producing the Product, ( ii ) manufacturing, filling and/or finishing Product or any component thereof, ( iii ) storing, insuring and packaging Product, and ( iv ) release and stability testing Product, including with respect to the foregoing, all taxes ( other than income taxes ) and customs duty charges imposed by govenunental authorities with respect thereto, to the extent paid by ANESIV A and not reimbursed or refunded by a third party ; ( b ) The direct costs and charges incurred by ANESIV A in connection with the manufacture, t111ing, finishing, testing ( including direct quality control and quality assurance activities ), storing, insuring and packaging Product not otherwise accounted for pursuant to subsection ( aJ above ; and ( c ) A reasonable allocation of indirect labor, administration costs and facilities costs ( including electricity, water, sewer, waste disposal, property taxes and depreciation over the expected life of buildings and equipment ) attributable to the manufacture, filling, finishing, testing, storing, insuring and packaging of Product ; provided that such indirect labor, administration costs and facilities costs shall only include an allocation ) to the units or sections directly engaged in the activities listed in the subsection ( b ) above, of such indirect labor ) administration costs andlor facilities costs incurred by ANESIV A Without limiting the generality of the foregoing provisions of this § 1.17, Manufacturing Costs shall exclude, all costs and charges related to or occasioned by unused manufacturing capacity ; the manufacture of other products at ANESIVA 's or a third party contractor 's facility ; depreciation of ANESIV A 's Initials [ 1 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT . MARKFD BY BRACKETS . IS~-O-;-W = I'f'H THE SECURITIBS AND EXCHANGE COMM)SSION PURSUANT TO RULE 248 - 2 Of THE SECURITIES EXCHANGE ACT OF [ 934, AS AMENDED, CONFIDENTIAL Page 4 0121 property, plant or equipment not specifically related to manufacturing Product ; allocation of administrative costs and general corporate overhead of ANESIVA or its third party contractors ; ANESIV A 's cost of capital, whether or not such capital is attributable to the manufacturing of any Product ; and any employee costs associated with equity incentive plans, 1,18, shall mean the final approval of registrations and permits required by applicable Government Regulatory Authority in the Territory . In the People 's Republic of China, the Imported Drug License shall serve as the Marketing AuthOlizatiol1 . Tn Hong Kong and Macau, the Certificate of DnlglProduct Registration shall serve as the Marketing Authorization, 1.19 . ' ~Party " means a Party to this Agreement and any reference to a Party includes its successors and pennitted assigns ; ' means every Pru1y together, 1.20 . shall mean any legal person including, for example, an individual, corporation, partnership, Limited Liability CompanYj trust, business trust, association, Joint Stock Company, joint venture, pool, syndicate, sole proprietorship, unincorporated organization, governmental authority or any other fonn of entity, 1.21 . means A NESIV A ' 8 powder intradelmal injection system, comprising lidocaine hydrochloride monohydrate, 0.5 mg, indicated for use on intact skin to provide topicallocaJ analgesia prior to venipuncture or peripheral intravenous cannulation and rnarketed in the United States under the brand name ZingoTM, 1,22, nproprietary Marks ) ' means the marks, trademarks, trade names and other commercial symbols and related logos relating to the Product for use in the Territory, together with such other trade names, trademarks~ symbols . logos, distinctive names, service marks, marks, logo designs, insignia Or otherwise which may be designated by ANESIVA . The trademark for the Product is