Common use of Research Plan and Development Plans Clause in Contracts

Research Plan and Development Plans. (a) Within […***…], the JSC shall develop and adopt an initial Research Plan with respect to any Ambit Follow-On Compounds selected by the JSC for research under this Agreement or shall determine not to establish such a Research Plan (in which case Astellas shall have no further rights to Ambit Follow-On Compounds, as provided in Section 2.6.1). (b) Set forth on Exhibit C is the initial Development Plan for the Development Program for AC220 as of the Effective Date. The JSC will periodically review, consider and approve such revisions and amendments to the Research Plan and such initial Development Plan pursuant to Section 2.6.2(d). The Parties agree that within […***…], the JSC will meet to review and, if necessary, revise such initial Development Plan as set forth in Exhibit C. (c) In the event and at such time as the JSC selects any additional Licensed Compound to be the subject of an IND submission, the JSC shall discuss and agree on a Development Plan setting forth the details for all the tasks and activities of the Development Program covering the Product containing such Licensed Compound, and the budget and timeline (including Xxxxx charts) therefor. Each such Product-specific Development Plan shall include the specific details for: (i) any additional formal pre- CONFIDENTIAL clinical research efforts required to be conducted for the Product; (ii) all Clinical Trials and other clinical activities or studies to be conducted with respect to each Product to generate the data necessary for obtaining, maintaining or expanding Regulatory Approvals; (iii) all Phase IV Clinical Trials that are necessary or economically justifiable for marketing the Product; (iv) all manufacturing process-development and scale-up activities with respect to the Product; and (v) the regulatory plan for seeking, obtaining, maintaining or expanding Regulatory Approvals for such Product; in each case under (i) through (v) above, in or for the benefit of the Exploitation of Products in the Joint Development Territory. Each such Development Plan shall also allocate between the Parties all tasks and activities covered by such plan. (d) As necessary or appropriate throughout the term of this Agreement, but no less frequently than annually […***…], the JSC shall review and update and amend the Research Plan and each Development Plan as appropriate to achieve the goals of (i) completing all required research and development activities and obtaining Regulatory Approvals in Joint Development Territory for the applicable Products as soon as reasonably practicable and (ii) providing for any ongoing development (including additional Clinical Trials) determined to be necessary or reasonably useful in support of marketing any Product for which Regulatory Approval has been obtained in the Joint Development Territory.

Research Plan and Development Plans. (a) Within […***…], the JSC shall develop and adopt an initial Research Plan with respect to any Ambit Follow-On Compounds selected by the JSC for research under this Agreement or shall determine not to establish such a Research Plan (in which case Astellas shall have no further rights to Ambit Follow-On Compounds, as provided in Section 2.6.1). (b) Set forth on Exhibit C is the initial Development Plan for the Development Program for AC220 as of the Effective Date. The JSC will periodically review, consider and approve such revisions and amendments to the Research Plan and such initial Development Plan pursuant to Section 2.6.2(d). The Parties agree that within […***…], the JSC will meet to review and, if necessary, revise such initial Development Plan as set forth in Exhibit C. (c) In the event and at such time as the JSC selects any additional Licensed Compound to be the subject of an IND submission, the JSC shall discuss and agree on a Development Plan setting forth the details for all the tasks and activities of the Development Program covering the Product containing such Licensed Compound, and the budget and timeline (including Xxxxx Gxxxx charts) therefor. Each such Product-specific Development Plan shall include the specific details for: (i) any additional formal pre- CONFIDENTIAL clinical research efforts required to be conducted for the Product; (ii) all Clinical Trials and other clinical activities or studies to be conducted with respect to each Product to generate the data necessary for obtaining, maintaining or expanding Regulatory Approvals; (iii) all Phase IV Clinical Trials that are necessary or economically justifiable for marketing the Product; (iv) all manufacturing process-development and scale-up activities with respect to the Product; and (v) the regulatory plan for seeking, obtaining, maintaining or expanding Regulatory Approvals for such Product; in each case under (i) through (v) above, in or for the benefit of the Exploitation of Products in the Joint Development Territory. Each such Development Plan shall also allocate between the Parties all tasks and activities covered by such plan. (d) As necessary or appropriate throughout the term of this Agreement, but no less frequently than annually […***…], the JSC shall review and update and amend the Research Plan and each Development Plan as appropriate to achieve the goals of (i) completing all required research and development activities and obtaining Regulatory Approvals in Joint Development Territory for the applicable Products as soon as reasonably practicable and (ii) providing for any ongoing development (including additional Clinical Trials) determined to be necessary or reasonably useful in support of marketing any Product for which Regulatory Approval has been obtained in the Joint Development Territory.