definiens: has the meaning ascribed thereto in Section 5.3 ; 2.2 means any individual, company, partnership or other entity which directly or indirectly, at present or in the future, controls, is controlled by or is under common control with a Party ; 2.3 means this development and manufacturing agreement ; 2.4 means for each batch of Product manufactured in Step 5, the production protocols showing how the batch was manufactured ; 2.5 means a document carrying Product and/or Project identification, and stating for the Process the list of analytical tests, their standard methods and procedures, and the criteria to be met during the cGMP nlanufacturing Product, and all amendments thereto, to be agreed upon behveen the Parties ; 2.6 means a so - called contemplated change notification describing any Inaterial deviation from the Project, which notice is provided in writing by DSM.Biologics to CYTOGEN and must be approved by CYTOGEN in writing prior to taking effect ; 2.7 means current good nlanufacturing practices and general biological products standards as pronlulgated under the United States Federal Food, Drug and Cosnletic Act at 21 CFR, Canadian Good Manufacturing Practices and the EEC Guide to Good Manufacturing Practices for Medical Products ( Vol . IV -rules governing nledical products in the European Conlnlunity 1989 ) ; 2.8 means any and all c1ainls, denlands, losses, obligations, liabilities, datnages, deficiencies, actions, settlements, judglnents, cost and expenses which a Party may incur or suffer ( including reasonable costs and legal fees incident thereto or in seeking indenlnification therefor ) ; 2.9 nleans the costs for the Project, which costs shall exclude the Price but shall include the costs of raw materials, filters, resins, Product release testing, external testing, any royalties to be paid to third parties, subcontractor costs, out of pocket expenses, travel and lodging costs, capital investtnents, shipping Product, insuring shipped Products, and all brokers fees, customs duties, import duties, excise taxes and other taxes payable in connection \vith the delivery of Product ; 2.10 means [COMPANY] Corporation ; 2, 2.11 has the meaning ascribed thereto in Section 14.1 ; 2.12 means any and all current and future Intellectual Property Rights proprietary to CYTOGEN in so far as provided, granted, divulged or disclosed, either directly or indirectly by CYTOGEN to [COMPANY] Biologics, pertaining to the Project