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Development Plans
Development Plans contract clause examples

For each Licensed Product in the Field, Licensee will prepare and deliver to Licensor a development plan and budget (each a “Development Plan”). The initial Development Plans for the Licensed Product in the Field will be delivered within ​ after the Effective Date.

Development Plans. A Development Plan and budget for each Candidate for the balance of the Calendar Year during which the Compound or Abbott Compound is designated by the JSC as a Candidate shall be prepared by Abbott and submitted to the JSC promptly after the designation of such Compound or Abbott Compound as provided in [Sections 2.1.4(h) and 3.6]6]. Thereafter, for each Calendar Year during the Development Program, an updated Development Plan and budget for each Candidate shall be prepared by Abbott and submitted to the JSC as provided in [Section 2.1.4(a) or (b)])], as applicable. To the extent JSC approval is required, the Parties shall manage the preparation of each Development Plan and budget in a manner designed to obtain such JSC approval no later than ​ days prior to the end of the then-current Calendar Year. Each Development Plan and amendment thereto shall: # set forth # the Development objectives, activities, priorities, timelines, budget and resources for the Calendar Year covered by the Development Plan with reasonable specificity, # the Development objectives and activities to be performed for each Calendar Year period covered by the Development Plan with reasonable specificity, broken down by Calendar Quarters, # the Party that shall be responsible for performing such activities, # a timeline for such activities and # the expected Development Costs over such Calendar Year; and # be consistent with the other terms of this Agreement.

Development Plans. The development of each Licensed Product under this Agreement after the completion of the applicable Research Plan shall be conducted pursuant to a development plan (each, a “Development Plan”). The Development Plan for a particular Licensed Product shall set forth a general timeline and all material development activities to be conducted in the Field ​.

Development Plans. An outline of all major Development activities to be conducted by [[FibroGen:Organization]] with respect to the Gal-9 Licensed Program is attached hereto as [Schedule 4.1] (Development Plan). Following the Option Exercise Date with respect to any Option Program, [[FibroGen:Organization]] will provide an updated Development Plan to HFB reflecting all major Development activities to be conducted by [[FibroGen:Organization]] with respect to the applicable Licensed Program. Additionally, prior to the first Regulatory Approval of a Licensed Product for each Licensed Program in a Major Market Country, [[FibroGen:Organization]] will provide an updated Development Plan with respect to such Licensed Program to HFB within ​ of each anniversary of the Effective Date based on the currently available information.

Kyorin Development Plans. On a Licensed Product-by-Licensed Product basis, the Development activities that are necessary or useful to be undertaken for such Licensed Product to achieve a Regulatory Approval in the Kyorin Territory will be set forth in reasonable detail in a written work plan and time table (each, as may be amended or updated, a “Kyorin Development Plan”) prepared by Kyorin. The initial Kyorin Development Plan ​ will be prepared by Kyorin no later than ​ days after the Effective Date. The terms of, and Development activities set forth in, each Kyorin Development Plan will at all times be designed to be in compliance with all applicable Laws and in accordance with professional and ethical standards customary in the pharmaceutical industry, and may at any time be amended, supplemented or otherwise modified in response to the communications with a Regulatory Authority in the Kyorin Territory with regard to such Development activities in accordance with Section 2.2.2.1. The JSC will review and provide input on each Kyorin Development Plan and will approve all such Kyorin Development Plans in accordance with Section 2.2.2.1. Kyorin will update each applicable Kyorin Development Plan for a Licensed Product ​ (such updates to include any Post-Marketing Studies required by a Regulatory Authority as a condition of granting any such marketing authorizations) and will provide such updated Kyorin Development Plan to the JSC for review, input and approval in accordance with Section 2.2.2.1.

Development Plans. Within 90 days after the Effective Date, Coya will provide to ARScience Bio a high level development plan for Products, describing at a high level the Development activities for Products to be carried out by Coya or its Affiliates or Sublicensees, including the specific objectives and an anticipated timeline for such activities (as may be updated from time to time in accordance with this Agreement, the “Development Plan”). At any time during the Term and, in any event, not less frequently than annually, Coya may provide to ARScience Bio an updated Development Plan.

Development Plans. [[Forty Seven:Organization]] shall prepare and present at the first JSC meeting for discussion a global development strategy that sets forth the high-level objectives and strategy (e.g., priority of target indications/tumor types) for the Development of Licensed Antibodies and Products worldwide (such strategy, and any amendments thereto, the “Global Development Strategy”). Within ​ following the Effective Date, each Party will be responsible for preparing a plan containing the strategy, activities and timeline for the Development of the Licensed Antibodies and Products in its respective Territory (as updated pursuant to this [Section 4.1.2], the “Ono Development Plan” and “[[Forty Seven:Organization]] Development Plan”). Each Party’s Development Plan shall include a planning horizon of ​ for all Clinical Studies and other Development activities with respect to the Licensed Antibodies and Products that are planned or are being conducted by such Party in its respective Territory, and to the extent reasonably practicable and subject to Section 3.3.2, be aligned with the Global Development Strategy. Each Party will deliver to the JSC an update of the relevant sections of its Development Plan no less frequently than ​ per Calendar Year during the Term. Subject to [Section 4.1.1], Ono will be solely responsible for all decisions regarding the day-to-day conduct of Development within the Ono Territory. Subject to [Sections 3.2.4.2 and 4.3.5]5], [[Forty Seven:Organization]] will be solely responsible for all decisions regarding the day-to-day conduct of Development within the [[Forty Seven:Organization]] Territory.

Development Plans. A Development Plan and budget for each Candidate for the balance of the Calendar Year during which the Compound or Abbott Compound is designated by the JSC as a Candidate shall be prepared by Abbott and submitted to the JSC promptly after the designation of such Compound or Abbott Compound as provided in [Sections 2.1.4(h) and 3.6]6]. Thereafter, for each Calendar Year during the Development Program, an updated Development Plan and budget for each Candidate shall be prepared by Abbott and submitted to the JSC as provided in [Section 2.1.4(a) or (b)])], as applicable. To the extent JSC approval is required, the Parties shall manage the preparation of each Development Plan and budget in a manner designed to obtain such JSC approval no later than ​ days prior to the end of the then-current Calendar Year. Each Development Plan and amendment thereto shall: # set forth # the Development objectives, activities, priorities, timelines, budget and resources for the Calendar Year covered by the Development Plan with reasonable specificity, # the Development objectives and activities to be performed for each Calendar Year period covered by the Development Plan with reasonable specificity, broken down by Calendar Quarters, # the Party that shall be responsible for performing such activities, # a timeline for such activities and # the expected Development Costs over such Calendar Year, including the U.S. Development Costs and the Global Development Costs; and # be consistent with the other terms of this Agreement.

Development Plans. If the Parties are unable to reach agreement upon and enter into the first Development Plan within ​ of the Effective Date, or if at any time after the second anniversary of the Effective Date there are no active Development Plans in place, either Party may terminate this Agreement upon written notice to the other Party.

Development Plans. The Development of the Licensed Product(s) in the Zai Lab Territory will be conducted by ​ pursuant to a plan that will include a description in reasonable detail of the Development activities to be performed in support of the Regulatory Approval of the Licensed Product(s) in the Zai Lab Territory, including ​ (each, a “Development Plan”). The initial Development Plan agreed to by the Parties is attached hereto as [Schedule 3.4] (Development Plan). Any material changes to the Development Plan will be proposed by the JDC to the JSC for the JSC’s review and consideration, including the addition of any Clinical Trial protocols or any material changes thereto. The JDC will propose updates to the Development Plan no less frequently than on an ​ basis thereafter. In the event of any proposed change to the Development Plan ​ to review and discuss any such proposed changes and determine an appropriate revision (if any) to the Development Plan.

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