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Sales), (h) sales and other excise taxes and duties or similar governmental charges directly related to the sale of Product (to the extent not already deducted as part of the calculation of Net Sales), and (i) any other direct and allocable internal costs and direct and allocable external costs incurred in conducting the Development and Marketing Program, all calculated in accordance with GAAP and all approved by the JDMC. Except to the extent this Agreement expressly provides for payments that do not require JDMC approval, and except to the extent the JDMC has approved any payment hereunder, neither Party shall (y) be obligated to incur any costs or expend any funds that have not been approved by such Party or (z) have the authority to cause the other party to incur any costs or expend any funds that have not been approved by such other Party. Notwithstanding anything to the contrary contained herein, Collaboration Costs shall not include (i) indirect costs, overhead, general and administrative costs and other similar costs, (ii) any costs which relate to the business of a Party as a whole without specifically referencing a Product or (iii) costs required to be paid by Palatin under the CT License Agreement (which shall be the responsibility of Palatin), including without limitation pursuant to the indemnification provisions thereof except to the extent the same are the result of the acts or omissions of King. 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Plan and Budget. Except in the case of Collaboration Costs incurred in accordance with Section 1.1.1, Collaboration Costs shall be limited to Joint Development Activities or Initial Development Activities, as the case may be, that are specifically identified in the applicable Development Plan and Budget; provided, however , that such costs shall be included in \u201cCollaboration Costs\u201d only to the extent less than or equal to the amounts set forth in the applicable Development Plan and Budget for such Joint Development Activities or Initial Development Activities, as the case may be (subject to permitted overruns pursuant to Section 3.4.4). Subject to the foregoing, Collaboration Costs shall include such costs in connection with the following activities, as applicable:\n1.29.1 pre-clinical and non-clinical activities such as toxicology and formulation development, test method development, stability testing, quality assurance, quality control development, and statistical analysis;\n1.29.2 Clinical Studies for a Licensed Product, including (i) the preparation for and Conduct of clinical trials; (ii) data collection and analysis and report writing; (iii) clinical laboratory work; (iv) regulatory activities in direct connection with such studies, including adverse event recordation and reporting, but not including regulatory activities relating generally to a Licensed Product and not directly related to such studies, such as regulatory activities relating to Drug Approval Applications;\n1.29.3 preparation of the common technical document to be used by both Parties in connection with the preparation of Regulatory Documentation for Licensed Products;\n1.29.4 Manufacturing Costs for (i) a Licensed Product for use in Clinical Studies or other Development activities for such Licensed Product; (ii) the manufacture, purchase or packaging of comparators or placebo for use in Clinical Studies for a Licensed Product (with the manufacturing costs for comparators or placebo to be determined in the same manner as Manufacturing Costs are determined for such Licensed Product) and (iii) costs and expenses of disposal of drugs and other supplies used in such Clinical Studies or other Development activities;\n1.29.5 Losses incurred in connection with Third Party Claims described in Section 11.3 to the extent such Losses are to be included in Collaboration Costs in accordance with Section 11.3; and\n1.29.6 Costs for the development of the manufacturing process for a Licensed Product, scale-up, manufacturing process validation, Manufacture of registration batches, manufacturing improvements, and qualification and validation of Third Party contract manufacturers. Notwithstanding the foregoing, Collaboration Costs shall not include any (i) FTE costs or other costs and expenses that are specifically identifiable or reasonably allocable to Unilateral Activities of either Party, or (ii) any filing fees in connection with the filing of applications for Regulatory Approval; (iii) FTE costs for regulatory personnel in either Party except as otherwise expressly provided in Sections 1.29.2 or 1.29.3; or (iv) Manufacturing Costs for commercial supply of any Licensed Product. Specific terms in this Exhibit have been redacted because such terms are both not material and are of the type that the Company treats as private or confidential. These redacted terms have been marked in this Exhibit with three asterisks [***].", "hash": "a96881b5446087830624449bd71c38be", "id": 6}, {"snippet_links": [{"key": "section-51", "type": "clause", "offset": [36, 47]}, {"key": "this-agreement", "type": "clause", "offset": [51, 65]}], "samples": [{"hash": "g0RNXCimZiV", "uri": "/contracts/g0RNXCimZiV#collaboration-costs", "label": "Research and Development Collaboration and Option Agreement (Molecular Partners Ag)", "score": 35.1984941821, "published": true}], "size": 1, "snippet": "shall have the meaning set forth in Section 5.1 of this Agreement.", "hash": "4c31253010dcd888d389af4f4cf9c5d3", "id": 7}, {"snippet_links": [{"key": "costs-incurred", "type": "definition", "offset": [10, 24]}, {"key": "by-a-party", "type": "clause", "offset": [25, 35]}, {"key": "directly-attributable", "type": "definition", "offset": [63, 84]}, {"key": "conduct-of-the-collaboration", "type": "clause", "offset": [118, 146]}, {"key": "provided-that", "type": 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"CmASWmoVc35sYXdpbnNpZGVyY29udHJhY3RzcjwLEhpEZWZpbml0aW9uU25pcHBldEdyb3VwX3Y1NiIcY29sbGFib3JhdGlvbi1jb3N0cyMwMDAwMDAwYQyiAQJlbhgAIAA=", "definition": {"title": "Collaboration Costs", "size": 29, "snippet": "has the meaning set forth in Section 3.4.", "id": "collaboration-costs", "examples": ["For clarity, manufacturing costs included in the <strong>Collaboration Costs</strong> shall not exceed [***] Dollars ($[***]) per single shift day for standard costs and shall not include any costs associated with capital expenditures for Liquidia\u2019s manufacturing facilities unless otherwise agreed by the Parties in accordance with Section 2.1(e)(ii).", "For the avoidance of doubt, the <strong>Collaboration Costs</strong> reimbursed to Liquidia by GSK shall be used by Liquidia solely to cover the costs of the conduct of the Inhaled Plan that are incurred after the Effective Date.", "Within fifteen (15) days after the end of each calendar quarter during the Inhaled Collaboration Term, Liquidia shall submit to GSK a reasonably detailed report and any additional documentation reasonably requested by GSK, setting forth all <strong>Collaboration Costs</strong> actually incurred by Liquidia in the conduct of the Inhaled Program in accordance with the Inhaled Plan and associated budget during such calendar quarter.", "GSK shall reimburse Liquidia for the <strong>Collaboration Costs</strong> incurred as set forth in such report; provided, that any <strong>Collaboration Costs</strong> incurred in excess of [***] percent ([***]%) of the budgeted <strong>Collaboration Costs</strong> for the applicable quarter shall be borne by Liquidia unless such overage was approved in advance by the JSC.", "Notwithstanding the foregoing, any <strong>Collaboration Costs</strong> that are incurred by Liquidia as a result of Liquidia\u2019s failure to use Commercially Reasonable Efforts or due to Liquidia\u2019s negligence, whether or not such <strong>Collaboration Costs</strong> are in excess of [***] percent ([***]%) of the budget for the applicable quarter, shall be borne entirely by Liquidia.", "GSK shall reimburse Liquidia for the <strong>Collaboration Costs</strong> as set forth in Section 10.2. For the avoidance of doubt, GSK shall be responsible for all costs and expenses incurred by GSK to conduct the Inhaled Collaboration.", "Out-of-pocket costs allocable to <strong>Collaboration Costs</strong>, but otherwise included within FTE Costs, shall not be charged separately as <strong>Collaboration Costs</strong>.", "GSK shall reimburse such <strong>Collaboration Costs</strong> within sixty (60) days after receipt of an invoice from Liquidia, which invoice shall be sent in PDF format to [***] with a copy to [***] (or such other email address(es) as may be notified to Liquidia by GSK).", "All costs and expenses incurred by or on behalf of the Parties (or their Affiliates) in connection with effecting such technology transfer in accordance with Exhibit H will be Shared <strong>Collaboration Costs</strong>.", "In the event that Moderna incurs costs and expenses in excess of [***] in connection with taking such corrective actions in accordance with such plan and budget, such excess costs shall be treated as Shared <strong>Collaboration Costs</strong> with respect to the PCV Program under Exhibit D."], "related": [["commercialization-costs", "Commercialization Costs", "Commercialization Costs"], ["development-expenses", "Development Expenses", "Development Expenses"], ["development-costs", "Development Costs", "Development Costs"], ["transition-costs", "Transition Costs", "Transition Costs"], ["exploration-costs", "Exploration Costs", "Exploration Costs"]], "related_snippets": [], "updated": "2025-07-06T21:56:45+00:00"}, "json": true, "cursor": ""}}