R&D Plans and Budgets Clause Samples
R&D Plans and Budgets. (a) The R&D Program shall be performed, on a New Candidate by New Candidate and Collaboration Product-by-Collaboration Product basis and, where relevant, a country-by-country basis, in accordance with a general work plan which shall describe, in reasonable detail, the research and Development activities and phases to be performed under the R&D Program for the relevant product, including pre-clinical study designs, clinical trial descriptions for all proposed targets, specific activities and deliverables to be performed and provided by the Parties, estimated timelines, and key milestones (“R&D Plan”) as well as the associated estimated costs per study, subject to the Total Studies Cap (“R&D Budget”). The R&D Budget shall include the estimated costs and expenses of Development (including external and internal, and notably CMC development costs) for the relevant product in each Calendar Year of the corresponding Term, including the Clinical Transfer Price and all Logistics Costs which shall borne by Molecular Partners on and subject to the terms of the Clinical Supply Agreement. The initial R&D Budget will cover the [***] period from the first target nomination; provided that, if the assumptions set out in the R&D Budget were to vary without OMT’s agreement, OMT shall not be bound to continue performing the affected activities and the Parties shall confer to discuss how to adjust the R&D Budget accordingly.
R&D Plans and Budgets. (a) The R&D Program shall be performed, on a Collaboration Product-by-Collaboration Product basis and, where relevant, a country-by-country basis, in accordance with a general work plan which shall describe, in reasonable detail, the research and Development activities and phases to be performed under the R&D Program for the relevant Collaboration Product, including pre-clinical study designs, clinical trial descriptions for all proposed targets, specific activities and deliverables to be performed and provided by the Parties, estimated timelines, and key milestones (“R&D Plan”) as well as the associated estimated budgets integrated thereto by phase (“R&D Budget”). The R&D Budget shall specify the estimated costs and expenses of Development (including external and internal, and notably CMC development costs) for the relevant Collaboration Product in each Calendar Year of the corresponding R&D Term, including the Clinical Transfer Price and all Logistics Costs. The initial R&D Budget will cover [***].
(b) As of the Effective Date, the Parties have agreed on an R&D Plan for the First Product as the first Collaboration Product attached at Exhibit B hereto and on a corresponding R&D Budget, attached hereto as Exhibit C.
(c) The JSC shall review and, as required, update the then current R&D Plans and R&D Budgets at least once per Calendar Quarter; this is with the exception of the [***] of the Term, during which period the R&D Budget and R&D Plans should only be updated as deemed strictly necessary by the JSC. However, each Party must diligently inform the other Party of any foreseeable significant change of costs of a Clinical Trial at the earliest anticipation and shall request a meeting of the JSC to discuss the necessity of an update to the relevant then current R&D Budget.
(d) Under the R&D Program for the First Product and under the oversight of the JSC,
i. Molecular Partners shall be responsible for certain pre-clinical/clinical and other Development activities with respect to the First Product subject to its reliance on input from Orano Med with respect to development and integration of the TAT Technology as set out in the corresponding R&D Plan;
ii. Orano Med shall be responsible for certain pre-clinical/clinical and other Development activities with respect to the First Product, subject to its reliance on input from Molecular Partners with respect to Development and integration of the DARPin technology as set out in the corresponding R&D Plan; and
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R&D Plans and Budgets