Durect Development Responsibilities Clause Samples

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. (b) Subject to Section 7.5, Alpharma shall pay to Durect its Durect Development Costs incurred with the performance of the Durect Development Responsibilities on a monthly basis, net [**] from the receipt of an invoice therefor from Durect; provided that Alpharma shall have no obligation to reimburse Durect’s Development Costs in excess of the then-current Development Plan Budget, and Durect shall have no obligation to perform activities which would result in Durect incurring costs in excess of the then-current Development Plan Budget, in each case, until the JEC has approved any increase the Development Plan Budget. (c) Durect may, with the prior written consent of Alpharma (not to be unreasonably withheld, delayed or conditioned), retain Third Party contractors to perform some or all of the Durect Development Responsibilities so long as the Third Party is subject to the applicable terms of this Agreement, including confidentiality obligations to Durect that are no less stringent than the confidentiality obligations set forth in Section 10, and agrees to assign ownership of all work product and intellectual property rights relating to the Product resulting from such work to Durect. Durect’s selection of such Third Parties are subject to the prior written approval of Alph...