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Confidential treatment has been requested with respect to the omitted portions. its obligations under the then-current Annual Development Plan (without regard to the budget set forth in such Annual Development Plan), that are specifically identifiable (or reasonably and consistently allocable) to the Development of a Product and that are directed to achieving or maintaining Regulatory Approval of such Product. The Development Costs shall include amounts, without \u2587\u2587\u2587\u2587-up, that a Party pays to Third Parties involved in such Development of a Product, and all internal costs incurred by a Party in connection with such Development of such Product. Development Costs include the following: (a) Research Costs; (b) costs relating to the application of BioBetter Technology to Existing Antibodies and, subsequent to BMS\u2019 exercise of the BMS Option (if applicable), Option Antibodies (existing as of the date of such exercise) and any Future Antibodies resulting from such application; (c) preclinical costs such as toxicology and the creation of product assays such as those for pharmacokinetic and immunogenicity testing; (d) formulation development, test method development, delivery system development, stability testing and statistical analysis; (e) Clinical Costs; (f) expenses related to adverse event reporting; (g) Manufacturing Costs for a Product for use in preclinical and clinical activities including the manufacture, purchase or packaging of comparators or placebo for use in clinical studies of a Product (with the manufacturing costs for comparators or placebo to be determined in the same manner as Manufacturing Costs are determined for any Product), as well as the direct costs and expenses of disposal of drugs and other supplies used in such clinical studies; (h) Losses incurred in connection with claims set forth in Section 13.3, to the extent provided therein; and (i) development of the Manufacturing process for a Product (including with respect to any excipients or adjuvants included in such Products) and related scale-up, manufacturing process validation, manufacturing process improvements, and qualification and validation of Third Party contract manufacturers; (j) regulatory expenses relating to Development activities for the purpose of obtaining Regulatory Approval for an indication for a Product; and (k) other out-of pocket Product Development expenses that meet the criteria set forth above in this Section 1.17 including, without limitation institutional and advisory review boards, investigator meetings, quality of life studies, epidemiology and outcomes research. 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More specifically, development costs, including applicable operating costs of support equipment and facilities and other costs of development activities, are costs incurred to:", "id": "development-costs", "examples": ["Paragon shall keep complete and accurate books of account and records in sufficient detail to enable the <strong>Development Costs</strong> and Milestones payable under this Agreement to be determined.", "Korsa shall reimburse Paragon for the Pre-Effective Date <strong>Development Costs</strong> within [***] after \u2587\u2587\u2587\u2587\u2587\u2019s receipt of a written invoice that details the Pre-Effective Date <strong>Development Costs</strong>.", "For clarity, the Research Initiation Fees are nonrefundable, non-creditable, and separate from any <strong>Development Costs</strong> (including the Pre-Effective Date <strong>Development Costs</strong>) or Cost Advance paid or owing with respect to each Research Program.", "If the amounts paid for Third Party Costs for a Research Program exceed the Actual Quarterly Costs for such Research Program, then Paragon will credit such excess payment against <strong>Development Costs</strong> contemplated in the applicable Budget for such Research Program and reasonably expected to be incurred by Paragon in the performance of such Research Program during any upcoming Calendar Quarter and Korsa will deduct such amount from its next quarterly invoice.", "For clarity, the CMC Fee is separate from any <strong>Development Costs</strong> or Cost Advance paid or owing with respect to a Research Program."], "related": [["development-expenses", "Development Expenses", "Development Expenses"], ["development-cost", "Development Cost", "Development Cost"], ["commercialization-costs", "Commercialization Costs", "Commercialization Costs"], ["improvement-costs", "Improvement Costs", "Improvement Costs"], ["patent-costs", "Patent Costs", "Patent Costs"]], "related_snippets": [], "updated": "2026-06-11T05:32:52+00:00"}, "json": true, "cursor": ""}}