Joint Development Costs means all Third Party and out-of-pocket costs incurred by or on behalf of either Party or an Affiliate, calculated in accordance with GAAP consistently applied, that are reasonably and directly allocable to the Joint Post-Marketing Studies. Joint Development Costs shall include costs of contract research organizations and other Third Party vendors; costs of the Licensed Compound and/or Licensed Product; and other out-of-pocket costs actually incurred by each Party, but shall specifically exclude corporate overhead of each Party, and all internal FTE costs.
Joint Development Costs means all [***] by a Party or for its account and [***].
Joint Development Costs means, with respect to a Collaboration Product, the [***] and [***] costs [***] by a Party from the date of the relevant [***] to conduct Development for a Collaboration Product calculated in accordance with the Collaboration Accounting Policies, consistently applied. [***] will include [***] at the [***], [***] (including taxes and duties), and [***] required to [***] related to the relevant [***].
Examples of Joint Development Costs in a sentence
Where the JSC does not so designate excess Development Costs, any such unapproved excess Joint Development Costs shall be borne by the Party incurring them.
The Parties shall reimburse each other for their respective shares of such Joint Development Costs in accordance with Section 7.2(a).
The Parties shall each be responsible for fifty Percent (50%) of the Joint Development Costs incurred in connection with the performance by BioMarin (or Catalyst, if Catalyst is designated as the conducting Party under a Study Plan) of the Joint Post-Marketing Studies up to the amounts budgeted in Schedule 3.5 or, as applicable, in the agreed Study Plan (subject to Section 7.2(a)).
Furthermore, the amount in excess of the actual expenses shall be deducted from the Joint Development Costs reported by that Party and reconciled between the Parties.
Each Party shall also keep detailed records of the Joint Development Costs it incurs, including all supporting documentation for such expenses, and will keep such records for at least three (3) years after the date that such expense was incurred.
More Definitions of Joint Development Costs
Joint Development Costs means all costs reasonably incurred by or on behalf of either Party after the Effective Date, including out-of-pocket costs actually incurred by each Party, [ * ], all as calculated in accordance with U.S. generally accepted accounting principles consistently applied or international financial reporting standards, as applicable, that are reasonably and directly allocable to such Party’s performance of its obligations under this Agreement with respect to any Shared Study (other than an Allos Study), to the extent that such costs do not exceed [ * ] of the budget therefor as specified in the Development Plan; provided, however, “Joint Development Costs” shall specifically exclude (i) all internal costs, and (ii) any and all costs associated with preparing and filing any and all Regulatory Materials and communicating with any Regulatory Authorities, in each case for the purpose of obtaining and maintaining Regulatory Approval.
Joint Development Costs means, [***].
Joint Development Costs means the aggregate sum of all costs and expenses to complete the Joint Development Activities (but excluding Joint Drilling Activities), including all amounts payable under any Project Agreement related to Joint Development Activities (but excluding Joint Drilling Activities) and costs incurred by either Party (in its capacity as an owner of the Project) in connection with the negotiation, preparation or execution of any Project Agreement.
Joint Development Costs means all Third Party and out-of-pocket costs incurred by or on behalf of either Party or an Affiliate, calculated in
Joint Development Costs means all Third Party and out-of-pocket costs incurred by or on behalf of either Party or an Affiliate, calculated in accordance with GAAP consistently applied, that are reasonably and directly allocable to the Joint Post-Marketing Studies. Joint Development Costs shall include costs of contract research organizations and other Third Party vendors; costs of the Licensed Compound and/or Licensed Product; and other out-of- pocket costs actually incurred by each Party, but shall specifically exclude corporate overhead of each Party, and all internal FTE costs.
Joint Development Costs means (a) Development Costs to the extent approved by the JDC and reasonably and directly allocable to activities conducted pursuant to the Agreement and the Joint Development Plan then in effect, incurred by the Parties in support of Development of Products in accordance with the Joint Development Budget (subject to any overages permitted pursuant to Section 3.3), including: (i) such costs for Clinical Trials and Non-Clinical Studies designed solely to support receipt of Regulatory Approvals for Products in the Shared Territory, (ii) such costs for Clinical Trials and Non-Clinical Studies designed to support receipt of Regulatory Approvals for Products in both the Shared Territory and any part of the Licensed Territory, allocated in the manner set forth in Section 3.3, (iii) such costs for CMC Activities conducted pursuant to the Joint Manufacturing Plan; (iv) such costs for compiling, filing and obtaining Regulatory Approvals of Products in or for the benefit of the Shared Territory; (v) such costs for CROs and other Third Parties in support of Development of Products in the Shared Territory; and (vi) such costs for drug product or comparator drug for use in the activities described in either clause (i) or (ii) above; including, with respect to all such Development Costs, internal FTE costs at the applicable FTE Rate; (b) recall expenses to be treated as Joint Development Costs pursuant to Section 4.2(a); (c) Manufacturing Costs to be [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. treated as Joint Development Costs pursuant to Section 7.5; (d) costs and expenses incurred in connection with a transfer of Manufacturing technology to be treated as Joint Development Costs pursuant to Section 7.10; (e) Third Party Payments to be treated as Joint Development Costs pursuant to Section 8.8; and (f) Damages from Third Party Claims to be treated as Joint Development Costs pursuant to Section 12.4; but in each case ((a) through (f)) excluding Commercialization Costs and each of the following (except to the extent included in Manufacturing Costs): tax liabilities, capital expenditures incurred by either Party to obtain or maintain manufacturing capacity for Products, and overhead and other indirect cost allocations from either Party. For clarity, Joint Development Costs ex...
Joint Development Costs shall [***]. For clarity, Joint Development Costs shall exclude Medical Affairs Activities Costs, Regulatory Costs and Commercialization Costs. For the avoidance of doubt, to the extent costs are partly directly attributable to the Joint Development Activities and partly attributable to other activities of COMPANY or MorphoSys (in particular Sole Funded Development Activities), such costs shall constitute "Joint Development Costs" on a pro rata basis, which calculation shall be agreed between the Parties in good faith.