General Obligations of Myovant. Other than Takeda’s Permits and establishment fees related to Takeda’s manufacturing facilities, Myovant shall obtain and maintain at its expense during the Term all Permits as well as all Regulatory Approvals required for Myovant to use the Drug Substance or Drug Product in accordance with the License Agreement and fulfill its obligations under this Agreement, the License Agreement and the Quality Agreement. Myovant shall, and shall ensure that its Affiliates, Sublicensees and Subcontractors: (a) comply with the requirements and restrictions of any Permits and other Applicable Laws applicable to the use of the Drug Substance or Drug Product in accordance with the License Agreement; (b) use the Drug Substance or Drug Product in compliance with Applicable Laws and the TAK-385 Licensed Product INDs; and (c) comply with Myovant’s obligations under this Agreement.
Appears in 3 contracts
Samples: Manufacturing Agreement (Myovant Sciences Ltd.), Manufacturing Agreement (Myovant Sciences Ltd.), Manufacturing Agreement (Myovant Sciences Ltd.)
General Obligations of Myovant. Other than Takeda’s responsible Permits and establishment fees related to Takeda’s manufacturing facilitiesManufacturing facilities pursuant to Section 5.1 hereof, Myovant shall obtain and maintain at its expense during the Term all Permits permits as well as all Regulatory Approvals required for Myovant to use the Drug Substance or Drug Product in accordance with the License Agreement and fulfill its obligations under this Agreement, the License Agreement and the Quality Agreement. Myovant shall, and shall ensure that its Affiliates, Sublicensees and Subcontractors: (a) comply with the requirements and restrictions of any Permits permits and other Applicable Laws applicable to the use of the Drug Substance or Drug Product in accordance with the License Agreement; (b) use the Drug Substance or Drug Product in compliance with Applicable Laws and the TAK-385 Licensed Product INDsLaws; and (c) comply with Myovant’s obligations under this Agreement.
Appears in 3 contracts
Samples: Commercial Manufacturing & Supply Agreement (Myovant Sciences Ltd.), Commercial Manufacturing & Supply Agreement (Myovant Sciences Ltd.), Commercial Manufacturing & Supply Agreement (Myovant Sciences Ltd.)