Example ContractsClausesDevelopment Plan
Development Plan
Development Plan contract clause examples

Development Plan. MTPC will provide a proposed initial Development Plan to the JSC within ​ of the Effective Date. The initial Development Plan shall be agreed upon by the Parties through the JSC within ​ following receipt. MTPC will direct, coordinate and manage the Development of the Product in the Field in the Territory in accordance with the Development Plan. The Development Plan will include, among other things, for the NMOSD indication and for each LCM Indication, critical activities to be undertaken, timelines, and allocations of responsibilities between the Parties for the various activities to be undertaken under the Development Plan. During the Term, MTPC will amend the Development Plan on an ongoing basis as necessary, any amendments (other than amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities) being subject to review and approval by the JSC, and any amendments required to comply with Applicable Laws or written requirements imposed by Regulatory Authorities being subject to report to the JSC. The Development Plan must at all times contain terms that reflect the use of Commercially Reasonable Efforts to Develop the Product to obtain Regulatory Approval in the Field in the Territory and except otherwise expressly allocated to Viela in this Agreement including in [Section 4.1.3] (Development Cooperation), may not include any Development activities to be conducted by Viela beyond those set forth in the initial Development Plan, without Viela’s prior consent, which shall not be unreasonably withheld.

Development Plan. The Development Plan is attached hereto as [Schedule 3.2.1] and describes the allocation of activities between the Parties for the initial Development of Licensed Products for use in the Licensed Field in the Territory, in each case as applicable for a Licensed Product for use in a particular Indication in the Licensed Field ​.

Development Plan. All Development of the Product conducted by or on behalf of Ji Xing under this Agreement shall be conducted pursuant to a comprehensive written Development plan that sets forth the timeline and details of all clinical and regulatory activities to be conducted by or on behalf of Ji Xing to obtain and maintain Regulatory Approval of the Product in the Field in each Market in the Territory (the “Development Plan”). The Development Plan shall, except as expressly agreed by [[Cytokinetics:Organization]] in writing (e.g., to the extent required by the applicable Regulatory Authority or to address specific operational requirements in the Territory), be ​ and shall be focused ​. As of the Effective Date, the Parties have agreed to the initial Development Plan, which is attached hereto as [Exhibit B]. The JDC shall review and update the Development Plan within ​ after the Effective Date. From time to time, but at least once every ​, Ji Xing shall propose updates or amendments to the Development Plan in consultation with [[Cytokinetics:Organization]] and submit such proposed updated or amended plan to the JDC for review, discussion, and approval, including the protocols of all Clinical Trials of the Product to be conducted by Ji Xing in the Territory and all investigator-sponsored and investigator-initiated trials of the Product in the Territory, in each case prior to any patient enrollment. Once approved by the JDC, the updated or amended Development Plan shall become effective. From time to time at its discretion, ​ may propose updates or amendments to the Development Plan if it reasonably believes that the then effective Development Plan is insufficient or may have an adverse effect on ​.

Development Plan. Verrica shall Develop Product in the Licensed Field in the Territory pursuant to the Development Plan. Verrica shall provide Lytix with an initial, high level development plan (the “Initial Development Plan”) within ​ days after the Effective Date. Within ​ days after the Effective Date, Verrica will prepare and submit to the JSC a detailed plan containing the strategy, activities, study designs, timeline and budget for research and Development of the Product in the Licensed Field (the “First Supplemental Development Plan,” and together with the Initial Development Plan and any subsequent updates pursuant to this Section 4.1, the “Development Plan”). The First Supplemental Development Plan shall include among other things, all non-clinical and clinical studies, and regulatory activities with respect to the Product to be conducted by or on behalf of Verrica or its Affiliates or their respective sublicensees in the Licensed Field.

Development Plan. Within […​…] days of the delivery of the [Exhibit D] Documents pursuant to the first sentence of Section 2.1, [[Organization A:Organization]] shall deliver a copy of its proposed written plan describing in reasonable detail the proposed program of its initial Development for the first therapeutic indication of the Licensed Product(s). The initial Development Plan will focus on anticipated […​…] and […​…] (“Early Stage Development”) with an overview of [[Organization A:Organization]]’s […​…] and […​…] for Licensed Products (“Development Plan”) for [[Agenus:Organization]]’ review. During Early Stage Development [[Organization A:Organization]] plans to screen [[Agenus:Organization]] Antibody for incorporation into or admixture with [[Organization A:Organization]]’s proprietary sustained release gel formulation(s) known as RTGel™ or other proprietary or licensed technologies. Once a determination has been made by [[Organization A:Organization]] regarding whether [[Agenus:Organization]] Antibody is the lead candidate for use in development of the Licensed Product the next Development Plan update shall include the strategy for the initial Clinical Trials and the regulatory plan to support such Clinical Trials for such Licensed Product, as well as a rolling forecast of the quantity of [[Agenus:Organization]] Antibody that [[Organization A:Organization]] expects to need for preclinical studies and Clinical Trials (the “Forecast”) of the Licensed Product. The Forecast shall cover the remainder of the calendar year in which the Development Plan was approved and the […​…] years thereafter. The Forecast shall be divided into […​…] and shall include a delivery 36165924.6

Development Plan. Attached hereto as Exhibit B is the initial Development Plan, setting forth the activities to be conducted by [[Savara:Organization]] to Develop a Licensed Product for the Initial Indication, and a detailed budget (the “Budget”) of the Development Costs allocated to such Development and each such activity, including, but not limited to the status of financing the Development of such Licensed Product for the Initial Indication. From time to time throughout the Development of such Licensed Product for the Initial Indication, [[Savara:Organization]] may revise the Development Plan in its sole and absolute discretion, to reflect additional or different activities which are appropriate in light of the prior Development, and to reflect any changes in the cost of conducting such revised Development activities, provided it uses Diligent Efforts to Develop Licensed Products.

Development Plan. Prior to commencement of any Development of a Product as authorized or otherwise permitted by Section 4.3, Bausch Health shall provide Clearside with a written development plan that contains, in reasonable detail, all major Development activities anticipated for at least the subsequent ​ period (including all Clinical Trials) and proposed

Development Plan. [Schedule 3.1.2] sets forth an initial development plan for the Licensed Compounds and Licensed Products in the Field in the Territory (such plan, as amended from time to time in accordance with this Agreement, the “Development Plan”). From time to time, Acer may amend the Development Plan on written notice to [[Sanofi:Organization]] and Acer shall consider in good faith incorporating any reasonable comments of [[Sanofi:Organization]] to such amendment (however [[Sanofi:Organization]] shall have no obligation to comment on the Development Plan). The Development Plan shall reflect the Development activities that Acer believes, in good faith, to be required in order for it to satisfy its obligations under [Section 3.1.3]. The Development Plan shall set forth the Development objectives, the planned Clinical Studies and other planned Development activities (including regulatory filings and communications) and the contemplated timelines for the foregoing. The Development Plan shall be the Confidential Information of Acer.

Development Plan. All Development of the Product conducted by or on behalf of Ji Xing under this Agreement shall be conducted pursuant to a comprehensive written Development plan that sets forth the timeline and details of all clinical and regulatory activities to be conducted by or on behalf of Ji Xing to obtain and maintain Regulatory Approval of the Product in the Field in each Market in the Territory (the “Development Plan”). The Development Plan shall, except as expressly agreed by [[Cytokinetics:Organization]] in writing (e.g., to the extent required by the applicable Regulatory Authority or to address specific operational requirements in the Territory), be ​ and shall be focused ​. As of the Effective Date, the Parties have agreed to the initial Development Plan, which is attached hereto as [Exhibit B]. The JDC shall review and update the Development Plan within ​ after the Effective Date. From time to time, but at least once every ​, Ji Xing shall propose updates or amendments to the Development Plan in consultation with [[Cytokinetics:Organization]] and submit such proposed updated or amended plan to the JDC for review, discussion, and approval, including the protocols of all Clinical Trials of the Product to be conducted by Ji Xing in the Territory and all investigator-sponsored and investigator-initiated trials of the Product in the Territory, in each case prior to any patient enrollment. Once approved by the JDC, the updated or amended Development Plan shall become effective. From time to time at its discretion, ​ may propose updates or amendments to the Development Plan if it reasonably believes that the then effective Development Plan is insufficient or may have an adverse effect on ​.

Development Plan. All Development of the Products in the Territory will be governed by a written development plan, as such development plan may be revised by Akebia in its sole discretion from time to time (the “Development Plan”). The initial Development Plan is attached hereto as [Schedule 3.3]. For the avoidance of doubt, Akebia is under no obligation to provide Cyclerion notice of, or copies of, any changes to the Development Plan.

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