Example ContractsClausesGlobal Development Plan
Global Development Plan
Global Development Plan contract clause examples

The term “Global Development Plan” shall mean the plan of Clinical Studies intended to support Regulatory Approval of the Products in the Field and in the Territory, ​. The initial Global Development Plan is as attached in [Appendix 1.47].

Global Development Plan. In the event Relay exercises its Opt-In Right, then this Section 3.5 will apply during the Opt-In Term.

Global Development. The Party to which a particular Development activity is allocated under the Global Development Plan will lead the performance thereof and all Clinical Trials and Development activities for the Licensed Antibody and Licensed Product in the Territory will be conducted by the Parties as set forth in the Global Development Plan.

Global Development Plan. The JDC will establish the required form and contents of the global development plan (as may be amended, the “Global Development Plan”) and will oversee the Development of Products by the Parties in the Field in the Territory. Each Product will be Developed in accordance with the Global Development Plan. The Global Development Plan will include a plan for the Development of a Product in the Field in the Territory through Regulatory Approval, including a regulatory strategy, high-level study design criteria, an allocation of responsibilities between the Parties, timelines and a budget for activities conducted under the Global Development Plan (the “Development Budget”). The Parties shall cooperate to prepare the initial Development Budget, which shall be reviewed and approved by the JDC as part of the Global Development Plan. The JDC will update the Global Development Plan on an annual basis (or more frequently as needed) and submit it to the JSC for approval. The Parties will establish a project team (the “Project Team”) to oversee and coordinate activities under the Global Development Plan. The Project Team will be formed with an experienced team leader selected by mutual agreement of the Parties (“Project Leader”), and the composition of the Project Team will be determined by the Project Leader based on available personnel from each Party across functions. The Project Team will conduct its responsibilities under the Global Development Plan in good faith and with reasonable care and diligence. The Project Team will provide the JDC with periodic updates regarding the progress of activities pursuant to the Global Development Plan.

The term “Global Development Plan Budget” shall mean the non-binding, forecasted annual budget for the development activities under the Global Development Plan, ​.

Global Development Plan. Development of the Licensed Products in the Field will be conducted pursuant to a worldwide strategic plan (as may be amended or updated, the “Global Development Plan”). aTyr will prepare the initial Global Development Plan based on the aTyr Development Plan and the initial Kyorin Development Plan, and will provide such initial Global Development Plan to Kyorin within ​ days after the date on which the initial Kyorin Development Plan is provided to aTyr. The Global Development Plan will be consistent with the aTyr Development Plan, the Kyorin Development Plan and the Multi-Regional Clinical Trials Principles. aTyr will update such Global Development Plan annually thereafter based on the updated Kyorin Development Plan and will provide such updated Global Development Plan to the JSC for access by Kyorin. The terms of, and Development activities set forth, in each Global 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. The JSC will review and provide input on each Global Development Plan in accordance with Section 2.2.2.2.

Global Development Plan. Except with respect to Relay’s obligations under Section 3.3 and 3.4, Licensee will use Commercially Reasonable Efforts to Develop the Lead Products in the Field in the Territory in accordance with the Global Development Plan, subject to any amendments to the Global Development Plan, which will be subject to JDT approval in accordance with [Section 10.2.2(g)]. For clarity, Licensee may at its option Develop any such ​ Combination outside of the Global Development Plan, provided that the foregoing shall not limit the Parties rights and obligations with respect to sharing of Net Profits and Net Losses during the Opt-In Term as provided hereunder. In the event of any inconsistency between the Global Development Plan and this Agreement, the terms of this Agreement will prevail.

Performance under Global Development Plan. Without limiting the JDC’s rights to prepare, review and discuss, or the JSC’s rights to review, discuss and determine whether to approve each Global Development Plan and update thereto (other than the GSK Sole Development Activities), the Party to whom a particular Development activity is allocated under the Global Development Plan will have the right, without seeking JDC review or JSC approval, to make operational decisions with respect to the implementation and performance of such Development activity to the extent consistent with the then-current Global Development Plan and Global Development Budget.

Global Development Plan. Lyra’s global Development of the Licensed Product outside of the Territory and, ​, clinical Development within the Territory will be conducted pursuant to a written plan (the “Global Development Plan”). ​, Lyra will provide to the JSC for its review and discussion the initial Global Development Plan. The Global Development Plan will include an outline of all major Development activities for the Licensed Product to be conducted throughout the world by Lyra. From time to time, Lyra may propose updates to the then-current Global Development Plan for the Licensed Products, to the JSC to review and discuss and, solely to the extent relating to activities to be conducted by Lian in the Territory, to determine whether to approve such activities.

Subject to the terms and conditions of this Agreement, and except as otherwise provided in Article 6, the Parties shall jointly develop the Products in the Territory in accordance with the Global Development Plan and under the governance of the JSC. The responsibility of Roche and Atea to operationalize the global clinical development will be described in the Global Development Plan. The Global Development Plan shall be regularly amended and updated. Roche and Atea shall each use Commercially Reasonable Efforts to perform their respective tasks and obligations in conducting all activities ascribed to them in the then-current Global Development Plan, in accordance with the time parameters set forth therein. The Parties will share the costs associated with activities conducted under the Global Development Plan. FTE Costs and Out of Pocket Expenses incurred by or on behalf of either Party or any of its Affiliates in connection with its activities under the Global Development Plan​ shall be shared equally (50/50) by the Parties, ​. Neither Party shall pursue Third Party funding for any Clinical Study under the Global Development Plan that is not an Atea Ongoing Study without the approval of the JSC.

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