Examples of Joint Development Activities in a sentence
Incyte shall be the lead Party for clinical supply for any Program 1Joint Development Activities, provided that Incyte shall consult with Merus and shall consider Merus’s comments in relation to such clinical supply activities in good faith and accommodate any reasonable request by Merus to provide Program 1 Antibody and Program 1 Product for Program 1 Joint Development Activities.
The JDC shall review each Development Plan and Budget covering all Joint Development Activities at least [***] for the purpose of considering appropriate amendments thereto.
Each Party shall record and account for its FTE Costs and its out-of-pocket costs for the Initial Development Activities and Joint Development Activities and shall report such costs to the JDC on a quarterly basis, in each case, in a manner that allocates costs to the extent possible to a specific activity in the applicable Development Plan and Budget.
It is contemplated that all Joint Development Activities shall be structured so as to support the filing of Drug Approval Applications for the Licensed Product both in the Major Markets and the United States.
Each Party shall use Commercially Reasonable Efforts to perform the responsibilities assigned to it under each Development Plan and Budget for Joint Development Activities in accordance with the budget set forth therein by allocating sufficient time, effort, equipment, and skilled personnel to complete such Development activities successfully and promptly.
In addition, either Party, through its representatives on the JDC, may propose amendments to any Development Plan and Budget for Joint Development Activities at any time.
Upon request of either Party, Incyte may negotiate and enter into a clinical supply agreement, for supply of Program 1 Antibody and Program 1 Product for use in Clinical Trials, including formulation and CMC work which shall be included within Program 1 Joint Development Activities.
After the exercise by Licensee of its Collaboration Candidate Option with respect to a Collaboration Compound and such Collaboration Compound becoming a Licensed Compound, either Party may propose further Development activities (outside of the applicable Collaboration Candidate Development Plan and Budget) for such Licensed Compound and such proposal shall be deemed a proposal for further Joint Development Activities subject to Section 3.2.1.
The Parties shall Conduct Joint Development Activities in accordance with the terms and conditions of this Agreement and the applicable Development Plan and Budget.
In addition, and without limiting the foregoing, following the successful completion of the Joint Development Activities in accordance with the applicable Development Plan and Budget, Licensee shall file for, prosecute, and use Commercially Reasonable Efforts to obtain Regulatory Approval for the applicable Licensed Product in each Major Market for the relevant indication.