Durect Development Responsibilities Sample Clauses

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.
Sample 1
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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.
Sample 1
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, [* * *].
Sample 1
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. [* * *].
Sample 1

Related to Durect Development Responsibilities

  • Development Responsibilities Unless the Parties agree in writing upon an alternate allocation of responsibility, the Parties shall have the following rights and obligations with respect to operational responsibilities under each Development Plan:

  • Client Responsibilities You are responsible for (a) assessing each participants’ suitability for the Training, (b) enrollment in the appropriate course(s) and (c) your participants’ attendance at scheduled courses.

  • Joint Responsibilities 2.1.1 University and Affiliate each will identify, and notify each other of, a person responsible for serving as its liaison during the course of this affiliation. The appointment of liaisons shall be subject to mutual approval of the parties.

  • Management Responsibilities The exclusive representative recognizes the right and obligation of the School Board to efficiently manage and conduct the operation of the School District within its legal limitations and with its primary obligation to provide educational opportunity for the students of the School District.

  • Management Responsibility No Limited Partner, as such, shall take part in the management of the business or transact any business for the Partnership.

  • Student Responsibilities The Student Agrees to:

  • Licensee Responsibilities 4.1 The Licensee will:

  • Client Responsibility For clarity, the parties agree that in reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. The Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by the Client.

  • Resident Responsibilities The Resident agrees to pay all fees specified, to observe all rules and regulations of the University of Connecticut and to abide by the Responsibilities of Community Life: The Student Code, this contract and any addendum, as well as other University publications/policies. Residents assume total responsibility for their room/suite/apartment/house and for the behavior and activities which occur within all assigned living areas. Applicants and/or residents cannot exchange money or favors for a room assignment. Failure to fulfill the terms of the above may lead to termination of this contract, removal from on-campus housing, and a community standards process resulting in a sanction, including but not limited to expulsion.

  • Department Responsibilities The use of sick leave may properly be denied if these procedures are not followed. Abuse of sick leave on the part of the employee is cause for disciplinary action. Departmental approval of sick leave is a certification of the legitimacy of the sick leave claim. The department head or designee may make reasonable inquiries about employee absences. The department may require medical verification for an absence of three (3) or more working days. The department may also require medical verification for absences of less than three (3) working days for probable cause if the employee had been notified in advance in writing that such verification was necessary. Inquiries may be made in the following ways:

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