Durect Development Responsibilities. If requested by Impax and agreed to by Durect [* * *], Durect will perform certain development activities (“Durect Development Responsibilities”) on a project-by-project basis in accordance with a mutually agreed work plan, which will include milestones and deliverables for each project. [* * *].
Durect Development Responsibilities. (a) Notwithstanding anything herein to the contrary, the following activities with respect to Product development are to be performed by Durect (collectively “Durect Development Responsibilities”): (i) Dosage Form Development; (ii) Preclinical and Non-Clinical studies; (iii) manufacturing method development, analytical method development, validation, stability and other CMC-related activities; (iv) manufacture of Product or Product Formulation, as applicable, required for all Clinical Trials through the completion of all Phase II Clinical Trials; (v) if Durect does not supply Product or Product Formulation, as applicable, for Phase III Clinical Trials or Commercialization as set forth in Section 8, management of any and all technology transfer, scale-up to commercial batch size and validation activities that may be required to enable any Person chosen by Zogenix and reasonably approved by Durect to manufacture Phase III Clinical Trial and commercial supplies of the Product or Product Formulation (as applicable); (vi) generation of necessary documents related to the Durect Development Responsibilities in order for Zogenix to perform Clinical Trials, complete Regulatory Documentation and Regulatory Approval Applications, and file for Regulatory Approvals in the Territory; and (vii) any other development activity to be performed by Durect, as mutually agreed by Zogenix and Durect. The Durect Development Responsibilities shall be detailed in a work plan (“Durect Work Plan”) agreed to in writing by the Parties which shall include the activities, timeline and detailed budget (“Durect Work Plan Budget”) associated with the Durect Development Responsibilities. Any amendments to the Durect Work Plan shall be agreed to in writing by the Parties. Durect shall use Commercially Reasonable Efforts to perform the Durect Development Responsibilities in accordance with the Durect Work Plan (including Durect Work Plan Budget and timeline set forth therein) for such Durect Development Responsibilities.
Durect Development Responsibilities. (a) Notwithstanding anything herein to the contrary, the following activities with respect to Product development are allocated to Durect (collectively “Durect Development Responsibilities”): (i) unless otherwise agreed upon by the Parties, all development activities through completion of Phase 2 [* * *]; (ii) Dosage Form Development; (iii) manufacturing and analytical method development, validation, stability and other CMC-related activities; (iv) management of any and all technology transfer, scale-up to commercial batch size and validation activities that may be required to enable any Person chosen by Alpharma to manufacture commercial supplies of the Product; (v) generation of necessary documents related to the Durect Development Responsibilities in order for Alpharma to perform Clinical Trials and file for Regulatory Approval in the Territory; and (vi) any other development activity allocated to Durect by Alpharma and agreed to by Durect. Durect shall use Commercially Reasonable Efforts to perform the Durect Development Responsibilities in accordance with the Development Plan (including Development Plan Budget and timeline set forth therein) for such Durect Development Responsibilities.
Durect Development Responsibilities. Durect shall use Commercially Reasonable Efforts to conduct,[* * *] the following activities (“Durect Development Responsibilities”) in accordance with the Development Plan: [* * *] The Durect Costs shall be borne by [* * *] pursuant to the Development Plan, provided however that if there will be any additional Durect Costs such additional Durect Costs shall be borne by [* * *] subject to [* * *]. Any invoice [* * *] shall be accompanied by the breakdown of such costs and expenses and reasonable documentation. For clarity, [* * *].
