Development Plan Delivery. By no later than November 1st of each Calendar Year during the Term after the Calendar Year in which the Initial Development Plan was delivered until First Commercial Sale of a Product in the United States, Adapt shall prepare a written development plan that describes generally the material Development activities to be undertaken by or on behalf of Adapt with respect to Products in the next Calendar Year (each, a “Development Plan”), and each such Development Plan shall be provided to Lightlake and Adapt shall consider any comments of Lightlake in good faith. The Initial Development Plan shall serve as the Development Plan for the first full Calendar Year of this Agreement and the period from the Effective Date through the end of the initial partial Calendar Year. Without limiting the generality of the foregoing, each Development Plan shall set forth, among other things and to the extent relevant based on the stage of Development, the following with respect to the Products then under Development: (a) any preclinical studies, toxicology studies and other clinical studies with respect to Products; (b) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals for Products; (c) the plans and timeline for preparing the necessary Regulatory Documentation and for obtaining Regulatory Approval for Products.
Appears in 6 contracts
Samples: License Agreement (Emergent BioSolutions Inc.), License Agreement (Opiant Pharmaceuticals, Inc.), License Agreement (Opiant Pharmaceuticals, Inc.)
Development Plan Delivery. By no later than November 1st of each Calendar Year during the Term after the Calendar Year in which the Initial Development Plan was delivered until First Commercial Sale of a Product in the United States, Adapt shall prepare a written development plan that describes generally the material Development activities to be undertaken by or on behalf of Adapt with respect to Products in the next Calendar Year (each, a “Development Plan”), and each such Development Plan shall be provided to Lightlake and Adapt shall consider any comments of Lightlake in good faith. The Initial Development Plan shall serve as the Development Plan for the first full Calendar Year of this Agreement and the period from the Effective Date through the end of the initial partial Calendar Year. Without limiting the generality of the foregoing, each Development Plan shall set forth, among other things and to the extent relevant based on the stage of Development, the following with respect to the Products then under Development:
: (a) any preclinical studies, toxicology studies and other clinical studies with respect to Products;
; (b) regulatory plans and other elements of obtaining and maintaining Regulatory Approvals for Products;
; (c) the plans and timeline for preparing the necessary Regulatory Documentation and for obtaining Regulatory Approval for Products.. 3.1.2
Appears in 1 contract
Samples: License Agreement