CMC Costs means external Costs and direct and indirect internal Costs associated with meeting the chemistry manufacturing and control requirements of the FDA and corresponding requirements in the EU and other countries of the world.
CMC Costs means all costs incurred by or on behalf of either Party that are reasonably and directly allocable to the conduct of the CMC activities described in the Manufacturing Plan including costs of producing the Compound or Product used in non clinical studies and in Clinical Trials for the Clinical Development Plan (i.e. excluding Product used in Clinical Trial for Territory Specific Work or for Unsponsored Work). CMC Costs shall include internal costs and reasonable out-of-pocket costs actually incurred by each Party. For clarity, equipment and facility depreciation and other allocations of fixed assets in use to support the development of Products are considered reasonably allocable costs and not corporate overhead to the extent and for so long as such equipment, facility and fixed assets are directly used for the development of the Products and set forth in the Manufacturing Plan.
CMC Costs means the (a) [**] and (b) [**], in each case ((a) and (b)), [**] in conducting the CMC Development activities allocated to it in a CMC Plan, but [**] under this Agreement.
Examples of CMC Costs in a sentence
Like the CMC, Costs Management has to be conducted as early as possible during the proceedings, lest the bulk of costs have already been incurred.
Until such time, the CMC Costs shall be included as part of Shared Costs and shall be split among the Parties in accordance with its Agreed Percentage.
Protagonist shall be responsible for one hundred percent (100%) of the Collaboration CMC Costs for the Phase 1 Activities incurred by either Party or any of their Affiliates, and Xxxxxxx shall be responsible for one hundred percent (100%) of the Collaboration CMC Costs for any Phase 3 Clinical Trial(s) incurred by either Party or any of their Affiliates.
More Definitions of CMC Costs
CMC Costs means all Out-of-Pocket Cost incurred by Pieris for manufacturing the Lead Product pursuant to Section 2.4.2.(a) (or Collaboration Product as applicable) as well as reasonable FTE Costs for managing the CMOs (with no premium or markup) in accordance with the applicable Joint Development Plan or Collaboration Plan and Joint Development Budget or Collaboration Budget.
CMC Costs means the FTE Costs (charged in accordance with Section 6.7) incurred, and the direct out-of-pocket costs recorded as an expense by a Party or any of its Affiliates after the Effective Date, during the Term of and pursuant to this Agreement that are specifically identifiable to CMC Development activities (including CMC Development activities performed by the Step-In Party pursuant to Section 3.14); provided, that such costs shall be included in “CMC Costs” only (i) to the extent consistent with the applicable Development Plan, or (ii) as otherwise mutually agreed by the Parties. ***Confidential Treatment Requested***
CMC Costs means all costs incurred by or on behalf of either Party that are [*]. CMC Costs shall include [*]. For clarity, [*].
CMC Costs means all internal and external costs incurred by a Party or any of its Affiliates after the Restatement Date, during the Term of and pursuant to this Agreement in connection with performing its obligations under the CMC Plan.
CMC Costs means all costs incurred by or on behalf of either Party that are reasonably and directly allocable to the conduct of the CMC Activities pursuant to the Manufacturing Plan, including (a) Manufacturing Costs related to Product used in non-clinical and clinical studies and (b) FTE Costs and reasonable out-of-pocket costs actually incurred by each Party. For clarity, equipment and facility depreciation and other allocations of fixed assets in use to support the Development of Products are considered reasonably allocable costs and not corporate overhead to the extent and for so long as such equipment, facility and fixed assets are directly used for the Development of the Products and set forth in the Manufacturing Plan.
CMC Costs has the meaning set forth on Exhibit A. **** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
CMC Costs means, with regard to a particular Product, the external and internal costs associated with the manufacturing, testing and release of Product up until the release of Phase III clinical materials for activities related to the [****] indication planed to be filed for such Product, authorized and approved by the JMC as part of the applicable Program Plan and Budget, as follows: