Development Plan and Implementation Sample Clauses
The Development Plan and Implementation clause outlines the requirements and procedures for creating, approving, and executing a detailed plan for a project's development. Typically, this clause specifies the responsibilities of each party in drafting the plan, sets timelines for submission and approval, and may include milestones or deliverables that must be met during the implementation phase. Its core practical function is to ensure that all parties have a clear, agreed-upon roadmap for the project's progress, reducing misunderstandings and helping to manage expectations and accountability throughout the development process.
Development Plan and Implementation. The Development of the Licensed Product in the Territory in the Field shall be conducted pursuant to a Development Plan, which as of the date of this Agreement consists of a set of principles and a preliminary timeline and is attached to this Agreement as Exhibit A (such plan, as amended from time to time, the “Development Plan”). Either Party may from time to time propose to the JSC for its consideration updates, amendments and modifications to the Development Plan; provided, that Salix shall propose an update to the Development Plan at least [*] per [*]. The Development Plan as updated, amended, progressed and modified from time to time by the JSC shall include the overall strategy and intended activities relating to the Development of the Licensed Product and in particular shall:
3.2.1. identify Development activities to be conducted and the anticipated timelines for such activities;
3.2.2. describe the clinical and regulatory strategy for the Licensed Product;
3.2.3. incorporate a manufacturing plan for the pre-clinical and clinical supplies of the Licensed Product to be provided by Lupin pursuant to Section 3.4;
3.2.4. incorporate a plan for scale up and commercial manufacture of the Licensed Product [*]; and
3.2.5. include such other matters as are from time to time appropriate to the Development of the Licensed Product.
Development Plan and Implementation. The Development of the Licensed Product in the Territory in the Field shall be conducted pursuant to a Development Plan, which as of the date of this Agreement consists of a set of principles and a preliminary timeline and is attached to this Agreement as Exhibit A (such plan, as amended from time to time, the “Development Plan”). Either Party may from time to time propose to the JSC for its consideration updates, amendments and modifications to the Development Plan; provided, that Salix shall propose an update to the Development Plan at least [*] per [*]. The Development Plan as updated, amended, progressed and modified from time to time by the JSC shall include the overall strategy and intended activities relating to the Development of the Licensed Product and in particular shall:
Development Plan and Implementation. The Development of the Licensed Product in the Field in the Territory shall be conducted pursuant to a Development Plan, which as of the date of this Agreement consists of a set of principles and a preliminary timeline and is attached to this Agreement as Exhibit A (such plan, as amended from time to time, the “Development Plan”). Either Party may from time to time propose to the JSC for its consideration updates, amendments and modifications to the Development Plan; provided, that Salix shall propose an update to the Development Plan at least [*] per [*]. The Development Plan as updated, amended, progressed and modified from time to time by the JSC shall include the overall strategy and intended activities relating to the Development of the Licensed Product and in particular shall:
3.2.1. identify Development activities to be conducted and the anticipated timelines for such activities;
3.2.2. describe the clinical and regulatory strategy for the Licensed Product;
3.2.3. incorporate a manufacturing plan for the pre-clinical and clinical supplies of the Licensed Product to be provided by Lupin pursuant to Section 3.4;
3.2.4. incorporate a plan for scale up and commercial manufacture of the Licensed Product [*]; and
3.2.5. include such other matters as are from time to time appropriate to the Development of the Licensed Product. Within ninety (90) days following the Amendment Effective Date, the Parties shall convene a meeting or teleconference between appropriate senior management representatives of each Party to review the Development Plan as it then exists and to discuss whether additional Licensed Products should be designated for Development hereunder. Salix shall, promptly following such meeting, update the Development Plan to reflect the outcome of the discussions at such meeting and submit such revised Development Plan for consideration by the JSC pursuant to Section 4.2.3. * Confidential treatment requested; certain information omitted and filed separately with the SEC.
Development Plan and Implementation