Required Studies definition

Required Studies means has the meaning provided in Section 3.1.

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Required Studies means those studies identified on Schedule “C” to this Agreement.

Required Studies means all pre-clinical or clinical studies for a Licensed Product (other than [***]) required by any Regulatory Authority in any Country in the European Union or the United States as a condition of obtaining Regulatory Approval for the Licensed Product in such Country, whether conducted prior to or after receipt of Regulatory Approval.

Examples of Required Studies in a sentence

• Cubist shall bear all of the costs and expenses in connection with any and all development activities engaged in by Cubist and its Affiliates in connection with all Required Studies.

• Citius has not received any notice or other indication from FDA that, in connection with the performance of the Required Studies, the sponsor of such studies would be required to maintain a patient registry.

• Citius will provide Licensee with regular reports with respect to the conduct of the Required Studies, and will share all data and results generated in connection with the Required Studies with Licensee, promptly after such data and results are generated (and all such data and results shall be deemed to be included in the Licensed Intellectual Property).

• Licensee and Citius shall each be responsible for funding fifty percent (50%) of the costs set forth in Exhibit C to perform the Required Studies.

• Citius will be responsible for conducting the Required Studies, in accordance with FDA requirements and Applicable Law and the Project Plan.

• Promptly after the Agreement Date, PPI shall provide EKR with copies of all agreements relating to the Required Studies and shall assign such agreements to EKR if and to the extent (i) such agreements are assignable in accordance with their terms and (ii) requested by EKR.

• PPI shall be responsible for all costs and liabilities incurred prior to the Agreement Date with respect to the Required Studies, and shall indemnify and hold harmless EKR from such costs and liabilities.

• EKR shall be responsible for the conduct of the Required Studies after the Agreement Date, at its own expense, in accordance with the requirements of the applicable Regulatory Authorities.

• For the avoidance of doubt and notwithstanding the foregoing reference to Section 5.3(a), such amount shall not be included in or subject to the Development Costs Cap, Annual Cap, Required Studies Cap or any other cap on reimbursement provided for herein.

• In the event that any Regulatory Authority in the GSK Territory (other than the EMEA) requires or requests in writing that Required Studies (other than those already initiated by Sepracor as of the Effective Date) be performed as a condition of, or in connection with, granting Marketing Approval, [**] whether or not to conduct such Required Studies and continue to [**] in such country.

More Definitions of Required Studies

Required Studies means any pre-clinical or clinical studies (other than those initiated by Sepracor prior to the Effective Date) that are required or requested in writing by any Regulatory Authority as a condition of, or in connection with, obtaining Marketing Approval for the Product in one of more countries in the GSK Territory.

Required Studies means core reload safety studies, compatibility studies, neutron start up studies and study activities related to core follow up, to the extent such studies are required to be undertaken after the Effective Date as determined by ▇▇▇▇▇▇▇▇▇▇;