Global Development Costs. With respect to any SMA Licensed Product, Genzyme shall be responsible for one-hundred percent (100%) of all Global Development Costs that occur after the Option Exercise Date for such SMA Licensed Product. Voyager shall be responsible for one-hundred percent (100%) of Global Development Costs for such SMA Licensed Product that occur prior to the Option Exercise Date for the SMA Licensed Product for goods and services to be performed prior to the Option Exercise Date. For clarity, Global Development Costs to be paid by Genzyme pursuant to this Section 5.3.4 (Global Development Costs) shall exclude any amounts paid after the Option Exercise Date for the SMA Licensed Product to Third Parties with respect to services rendered or services procured in connection with the conduct of any Clinical Study or Development activity that, in either case, is completed or performed prior to the Option Exercise Date for the SMA Licensed Product. Voyager CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. shall invoice Genzyme for the Global Development Costs to be paid by Genzyme pursuant to this Section 5.3.4 (Global Development Costs) and incurred by Voyager. Voyager shall provide copies of invoices from vendors and other supporting documentation as reasonably requested by Genzyme. Genzyme shall reimburse Voyager within [***] after receipt by Genzyme of such invoice. Genzyme shall reimburse Voyager on a quarterly basis for Development FTE Costs, Out-of-Pocket Costs and Cost of Goods incurred by Voyager in the performance of Transition Activities, within [***] after receipt by Genzyme of an invoice for such amounts from Voyager.
Global Development Costs. Repare shall be responsible for one hundred percent (100%) of all costs and expenses relating to Global Development Activities that are conducted by or on behalf of Repare, including Global Clinical Studies in the Repare Territory. In addition, Repare shall be responsible for all of its own costs and expenses relating to the preparation of initial Global Development Plan and all Global Common Costs. “Global Common Activity” means any Development activity with regard to any Global Clinical Study that is not specific to Development activities in the Ono Territory or the Repare Territory, which includes, but is not limited to, the project management, data management, statistical support and statistical analysis on a global basis (i.e. both of Repare Territory and Ono Territory). “Global Common Costs” means the direct development costs that are incurred by a Party in connection with the Global Common Activity. Ono shall be responsible for one hundred percent (100%) of all costs and expenses relating to Global Development Activities that are conducted by or on behalf of Ono, including Global Clinical Studies and any bridging studies conducted by Ono in the Ono Territory.
Global Development Costs. With respect to (A) the [***], and (B) [***], [***]Development Costs incurred by [***] in connection with the conduct of any Development Plan Activities that (A) are [***], and (B) [***] (e.g. [***]), as follows: (x) [***] such Development Costs, and (y) [***]such Development Costs.
Global Development Costs. SUPPLY OF COMMERCIAL REQUIREMENTS - The sales price of Product for commercial purposes shall be GENENTECH's Cost of Goods plus a mark-xx of twenty percent (20%) on FBMC. For the ROCHE Territory, such sales price will be billed to ROCHE and paid as follows:
Global Development Costs. Except as provided in this Section 5.7.2 (Global Development Costs), Kiniksa will be solely responsible for all costs and expenses incurred in connection with the Development of Licensed Product pursuant to the Global Development Plan and for the purpose of obtaining Regulatory Approvals and Reimbursement Approvals outside the Territory. Notwithstanding the foregoing, except as otherwise set forth in this Agreement, and only if Partner elects to serve as the Territory Sponsor in accordance with Section 5.3 (Global Development Plan) and Section 5.5 (New Development by Kiniksa), Partner will be responsible for and will pay (a) for all costs and expenses incurred in the furtherance of the conduct of any Global Clinical Trial in the Selected Territory GCT Countries and any other Clinical Development activities in the Selected Territory GCT Countries, to the extent assigned to Partner under the Global Development Plan, and (b) all other costs and expenses incurred by or on behalf of Partner in connection with the performance of any Clinical Development activities in the Selected Territory GCT Countries assigned to Partner under any Global Development Plan. Kiniksa will invoice Partner quarterly for the foregoing costs incurred by or on behalf of Kiniksa in such Calendar Quarter, and Partner will pay the undisputed invoiced amounts within [***] days after the date of any such invoice.
Global Development Costs. Global Development Costs shall mean the costs specifically attributable to the development of a Tripartite Licensed Product and actually incurred under the Global Development Plan after the Effective Date of the Agreement through the date of termination as defined under the Tripartite Agreement, provided that no Party shall be required to spend more than $100,000,000 unless otherwise agreed to by the Parties. Such costs shall comprise those costs, both direct and indirect including Development Allocable Overhead (i.e. fully burdened development costs), required to obtain, expand and/or maintain the authorization and/or ability to manufacture, formulate, fill, ship and/or sell a Tripartite Licensed Product in commercial quantities in the Global Development Countries. Global Development Costs shall include but are not limited to costs of development including cost of studies on the toxicological, pharmacokinetic, metabolic or clinical aspects of a Tripartite Licensed Product conducted internally or by individual investigators, or consultants, process development, process improvement, qualification lots, costs for preparing, submitting, reviewing or developing data or information necessary for the purpose of submission to a governmental authority in order to obtain, expand and/or maintain approval of a Tripartite Licensed Product in the Global Development Countries. Global Development Costs shall include expenses for data management, statistical designs and studies, document preparation, and other administration expenses associated with the clinical testing program or post registration clinical studies required to obtain, expand and/or maintain approvals in the Global Development Countries.
Global Development Costs. Except for Partner’s obligations under Section 5.5.3 (Partner’s Sharing of Development Costs), ImmunoGen will be [***] responsible for [***] in connection with the Development of Licensed Products pursuant to the Global Development Plan and for the purpose of obtaining Regulatory Approvals and Reimbursement Approvals outside the Territory. Notwithstanding the foregoing, except as otherwise set forth in Section 5.3 (Global Development Plan) and Section 5.5 (New Development by ImmunoGen), Partner will be responsible for [***].
Global Development Costs. Except as otherwise set forth in this Agreement, and otherwise subject to Section 5.1 (Global Development Plan), Zai will be responsible for and will pay (a) all Third Party out-of-pocket costs [****]
Global Development Costs. Subject to Section 6.1(a), Cidara and Mundipharma shall share equally (50/50) all Global Development Costs until such time as (a) Mundipharma has paid or reimbursed an aggregate of $31.207 million of Global Development Costs or (b) all GLP Studies, clinical trials and CMC development activities in the Global Development Plan have been completed or terminated, whichever occurs sooner, and after which time Cidara shall be solely responsible for 100% of Global Development Costs.
Global Development Costs. Within 30 days after the end of each calendar quarter during the performance of the Global Development Plan, each party shall provide to the other a written statement setting forth the Global Development Costs incurred by such first party and its Affiliates during such calendar quarter, such statement to include a reasonably detailed breakdown of the components of such Global Development Costs and the Global Development Plan activities to which such Global Development Costs are attributable (each such statement, a “Cost Report”). For the avoidance of doubt, Mundipharma may not submit a Cost Report to Cidara for Global Development Costs except to the extent the Global Development Plan contemplates Mundipharma incurring such amounts or such amounts have otherwise been approved by the JSC. Following receipt of Mundipharma’s Cost Report, if any, Cidara will provide Mundipharma with a written invoice for Mundipharma’s 50% share of the Global Development Costs for such calendar quarter; provided, however, that from and after such time as Mundipharma has paid or reimbursed an aggregate of $31.207 million of Global Development Costs, Cidara’s obligation to provide Cost Reports and its right to provide invoices to Mundipharma for Global Development Costs shall cease. Within 45 days after delivery of the Cost Report and associated invoice for a calendar quarter, Mundipharma shall pay the invoiced amount to Cidara (less any portion of such amount that Mundipharma disputes in good faith, of which Mundipharma shall promptly notify Cidara). Each party shall respond promptly to the other party’s questions regarding any Cost Report delivered hereunder or reasonable requests for supporting documentation, including, without limitation, copies of agreements or work orders for Global Development Plan activities performed by Third Parties (from which copies such party may redact confidential or proprietary information that is not necessary for the other party to ascertain Global Development Costs).
