Co-Development Costs means, with respect to a GSK Product, the sum of the following costs to the extent incurred after the exercise by GSK of an Option with respect to the GSK Development Program containing such GSK Product:
Co-Development Costs means all variable costs and fixed costs properly incurred by Dyax in the performance of the Dyax Co-Development Activities, all variable costs and fixed costs properly incurred by CAT in the performance of the CAT Co-Development Activities, and any Third Party License Costs. Co-Development Costs include, by way of example and without limitation, costs for the Co-Development Product incurred in (a) conducting clinical trials including costs of clinical laboratory, data management, toxicology and contract research organization services, (b) obtaining regulatory approval, (c) manufacturing the Co-Development Product, (d) prosecuting and maintaining any Patent Rights covering the Co-Development Product, and (e) conducting marketing, distribution and sales efforts including performing market research. For purposes of this definition, “variable costs” shall be deemed to be the cost of labor, raw materials, supplies and other resources directly consumed in a Party’s performance of its Co-Development Activities. For purposes of this definition, “fixed costs” shall be deemed to be the cost of facilities, utilities, insurance, facility and equipment depreciation and other fixed costs directly related to a Party’s performance of its Co-Development Activities, allocated based upon the proportion of such costs directly attributable to support of the Co-Development Activities or by such other method of cost allocation as may be approved by the Steering Committee. All cost determinations made hereunder shall be made in accordance with GAAP.
Co-Development Costs means all costs and expenses, [ * ] identifiable to the Co-Development of a Development Compound
Examples of Co-Development Costs in a sentence
Within [***] ([***]) days following the end of each Calendar Quarter following the exercise of the Co-Development Option applicable to a given Co-Developed Product, each of ImmunoGen and Biotest shall submit to the JFC a written report setting forth in reasonable detail all Co-Development Costs incurred by each such Party over such Calendar Quarter.
The Auditing Party shall bear the full cost of such audit unless such audit discloses an over reporting by the Audited Party of more than [***] [***] ([***]) of the aggregate amount of Co-Development Costs reportable in any Calendar Year, in which case the Audited Party shall reimburse the Auditing Party for all costs incurred by the Auditing Party in connection with such inspection or audit.
The JFC shall establish a schedule of times for regular meetings, taking into account, without limitation, the need to review Co-Development Costs incurred by the Parties and the Net Income received with respect to Co-Developed Products.
The Audited Party and its Affiliates shall each make its records available for inspection or audit by such independent certified public accountant during regular business hours at such place or places where such records are customarily kept, upon reasonable notice from the Auditing Party, solely to verify that Co-Development Costs hereunder were correctly determined.
Each Party shall keep and maintain for [***] ([***]) years complete and accurate records of Co-Development Costs incurred with respect to Licensed Products in sufficient detail to allow confirmation of same by the JFC.
More Definitions of Co-Development Costs
Co-Development Costs means the reasonable Out-of-Pocket Costs and internal costs incurred by a Party (or for its account by an Affiliate or a Third Party) on and after the exercise by ImmunoGen of the applicable Co-Development Option that are generally consistent with the respective activities allocated to such Party in the Co-Development Plan and/or Co-Development Marketing and Sales Plan and, in any case, are specifically attributable to the Development of a Co-Developed Product in the Co-Development Territory. For purposes of this definition (a) Out-of-Pocket Costs relate to the costs attributable to specific external Development activities, and/or Commercialization related to pre-commercial marketing activities, applicable to a Co-Developed Product, including, without limitation (i) all filing fees required for, and other costs associated with, any Regulatory Filings and Drug Approval Applications and (ii) all Third Party Required Payments; (b) internal costs means all direct labor costs to the extent attributable to the Development of a Co-Developed Product in accordance with the Co-Development Plan and/or Co-Development Marketing and Sales Plan, including, without limitation, any employees of a Party that perform project management and other activities attributable to such Development, all as calculated on the basis of an annual rate equal to the Party’s specific FTE Rate; and (c) the reasonable Out-of-Pocket Costs and internal costs of manufacturing or obtaining Co-Developed Products in final dosage form for use in the activities in clause (a) shall be included in the definition of Co-Development Costs. For the avoidance of doubt, Co-Development Costs (a) shall include the costs incurred by either Party in conducting clinical trials with respect to a Co-Developed Product, other than costs incurred with respect to Shared Clinical Trials as defined in 1.128(b), which shall be allocated between the Parties in accordance with Section 5.1.4 and Pivotal MAY Compound Process Development Costs, which shall be paid by Biotest in accordance with Section 5.1.5; and (b) shall not include (i) milestone payments made by Biotest to ImmunoGen pursuant to Section 6.3.1, and (ii) any Co-Development Option Exercise Fee to be paid by ImmunoGen pursuant to Section 5.1.1.
Co-Development Costs means the costs set forth in Schedule 13 hereto.
Co-Development Costs means [***] to [***] for a [***] in the [***] for a [***] shall [***]and [***], of the [***]:
Co-Development Costs means (a) the Development Costs for the Early Stage Program as further described in Section 2.1.1, and (b) in the case in which the Co-Development Option is exercised, Development Costs for the Post Phase Ia Program Plan as further described in Section 2.1.2(b).
Co-Development Costs means the reasonable Out-of-Pocket Costs and internal costs incurred by a Party (or for its account by an Affiliate or a Third Party) on and after the exercise by ImmunoGen of the applicable Co-Development Option that are generally consistent with the respective activities allocated to such Party in the Co-Development Plan and/or Co-Development Marketing and Sales Plan and, in any case, are specifically attributable to the Development of a Co-Developed Product in the Co-Development Territory. For purposes of this definition (a) Out-of-Pocket Costs relate to the costs attributable to specific external Development activities, and/or Commercialization related to pre-commercial marketing activities, applicable to a Co-Developed Product, including, without limitation (i) all filing fees required for, and other costs associated with, any Regulatory Filings and Drug Approval Applications and
Co-Development Costs means: (a) the internal and external costs set forth in the Budget and incurred by a Party during the Co-Development Period, and (b) up to a maximum amount of $[****] of documented, out-of-pocket transaction-related costs and expenses (such as attorney, consultant and investment banker fees) actually and reasonably incurred and paid by CicloMed in connection with the sourcing, negotiating, executing and closing of a Profit Generating Event. The Parties acknowledge and agree that CicloMed has contributed $[****] as of June 1, 2021 for the development of the Product and such amount will be considered a Co-Development Cost for purposes of calculating the percentage of CicloMed’s Compensation Share in the Net Proceeds. The Parties acknowledge and agree that Notable has contributed $[****] as of June 1, 2021 for the development of the Notable Test and such amount will be considered a Co-Development Cost for purposes of calculating the percentage of Notable’s Compensation Share in the Net Proceeds. The Co-Development Costs incurred by each Party as of June 1, 2021 are detailed on Exhibit B.
Co-Development Costs means, with respect to a Co-Developed Product, costs and expenses incurred in connection with the performance of any Development activity for such Co-Developed Product pursuant to a Co-Development Plan commencing upon Astellas’s exercise of its Development Option with respect to the corresponding Development Compound, including FTE costs for all Development activities reasonably contemplated under the Co-Development Plan for such Co-Developed Product following the exercise of such Development Option by Astellas, fees charged by Third Party service providers, and other out-of-pocket costs and cost of goods of clinical supplies relating to such Co-Developed Product (including destruction costs thereof, if applicable) reasonably incurred in connection with the performance of any clinical study with respect to such Co-Developed Product, including costs related to preparing and filing applications for Regulatory Approval or submissions to Regulatory Authorities (including associated filing fees, translation expenses and legal and other professional service fees), but excluding meeting related costs and expenses between the Parties (including JDC), entertainment expense and other overhead costs and capital expenditures.