Collaboration Costs definition
Collaboration Costs has the meaning set forth in Section 3.4.
Collaboration Costs means, to the extent approved by the JDMC, the sum of (a) Development Costs, (b) Manufacturing/CMC Costs, (c) Marketing Costs, (d) Regulatory and IP Costs, (e) product liability costs, as contemplated by Section 5.4, (f) any other cost or expense expressly stated to be a Collaboration Cost in this Agreement or under a Program Plan, (g) quantity, trade or cash discounts, chargebacks, returns, allowances, rebates (including without limitation any and all federal, state or local government rebates, such as Medicaid rebates) and costs incurred in connection with processing the foregoing and price adjustments, to the extent actually allowed in any invoice relating to Product (to the extent not already deducted as part of the calculation of Net 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. In calculating the Collaboration Costs, the following principles shall apply: (x) there shall be no double counting of any costs or expenses or of any revenues, and to the extent a cost or expense has been included in one category or sub-category, it shall not be included in another, and to the extent any revenue h...
Collaboration Costs means the following costs for activities set out in the Collaboration Plan (as may be amended pursuant to this Agreement):
(i) the FTE Costs;
(ii) Materials Costs; and
(iii) Out-of-Pocket Costs;
Examples of Collaboration Costs in a sentence
For clarity, manufacturing costs included in the Collaboration Costs shall not exceed [***] Dollars ($[***]) per single shift day for standard costs and shall not include any costs associated with capital expenditures for Liquidia’s manufacturing facilities unless otherwise agreed by the Parties in accordance with Section 2.1(e)(ii).
For the avoidance of doubt, the Collaboration Costs 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 Collaboration Costs 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 Collaboration Costs incurred as set forth in such report; provided, that any Collaboration Costs incurred in excess of [***] percent ([***]%) of the budgeted Collaboration Costs for the applicable quarter shall be borne by Liquidia unless such overage was approved in advance by the JSC.
Notwithstanding the foregoing, any Collaboration Costs that are incurred by Liquidia as a result of Liquidia’s failure to use Commercially Reasonable Efforts or due to Liquidia’s negligence, whether or not such Collaboration Costs are in excess of [***] percent ([***]%) of the budget for the applicable quarter, shall be borne entirely by Liquidia.
More Definitions of Collaboration Costs
Collaboration Costs means all costs and expenses of any kind incurred by or on behalf of any Party in performing its obligations under this Agreement or any Collaboration Project Plan or that are otherwise directly attributable to a Collaboration Project, including: (i) the internal costs and other expenses of each Party’s Representatives incurred in participating in and performing such Party’s obligations or activities under a Collaboration Project Plan and (ii) all costs and expenses associated with supplying any Materials to a Party for the purpose of allowing such Party to perform its obligations or activities under the Collaboration Project Plan.
Collaboration Costs means the FTE Costs (charged in accordance with Sections 6.1.2, 6.1.3, 6.1.4 and 6.
Collaboration Costs means the FTE Costs (charged in accordance with Section 3.4.2) incurred, and the direct out-of-pocket costs recorded as an expense in accordance with GAAP, by or on behalf of a Party or any of its Affiliates after the Effective Date and during the Term that are specifically identifiable or reasonably allocable to Joint Development Activities or Initial Development Activities, as the case may be, in accordance with the applicable Development 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 “Collaboration Costs” 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:
1.29.1 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;
1.29.2 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;
1.29.3 preparation of the common technical document to be used by both Parties in connection with the preparation of Regulatory Documentation for Licensed Products;
1.29.4 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 determi...
Collaboration Costs shall have the meaning set forth in Section 5.1 of this Agreement.
Collaboration Costs means the costs incurred by a Party or its Affiliates that are directly attributable, or reasonably allocable, to the conduct of the Collaboration Trials, provided that such costs are consistent with the applicable Development Plan (including the Collaboration Development Budget contained therein), including costs directly attributable to
Collaboration Costs means all Research and Development Costs and Commercialization Costs, in each case as such costs are incurred on or after the Effective Date.
Collaboration Costs means costs incurred by a Party that are reasonably necessary to perform its activities within the Collaboration Plan and all Regulatory, Support and Analytical Activities, including all such Party’s Out-of-Pocket Costs, FTE Costs and any other costs or expenses specifically identified to such Party and included in the Collaboration Plan or included as such Party’s Collaboration Costs under this Agreement.