Development Team Responsibilities Sample Clauses
Development Team Responsibilities. The DT shall be responsible for:
(i) developing an overall strategy for the Development of the Products in the Field in the Territory for review and approval by the JSC;
(ii) formulating the Development Plans (including the allocation of Development activities between the Parties) and associated annual budgets and any substantive amendments thereto for review and approval by the JSC, which Development Plans will include the plans for Manufacture development and associated annual budgets and any substantive amendments thereto received by the DT from the ST;
(iii) formulating the multiyear long-range plan for Development of the Products in the Field in the Territory (including the budget for Development Costs) for review and approval by the JSC;
(iv) implementing in coordination with the ST, as appropriate, all activities pursuant to the Development Plans approved by the JSC;
(v) making recommendations for further Development of the Products, including Development of the Products for a New Indication; ** CONFIDENTIAL TREATMENT REQUESTED
(vi) in consultation with intellectual property representatives of each Party, developing a strategy, and implementing methods for compliance, to protect trade secrets, know-how and other confidential material, data and information developed, made or conceived by the Parties pursuant to a Development Plan;
(vii) in consultation with the CT, developing and co-ordinating a communications and publication strategy for the Products in the Territory;
Development Team Responsibilities. The DT will perform the following functions:
(i) for the Alkermes 8700 Product in the Initial Indication in the U.S., formulating amendments to the Initial Development Plan, including, in each case, the applicable annual budget or the regulatory strategy, in each case, set forth therein;
(ii) coordinating implementation of all Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. pursuant to the Initial Development Plan;
(iii) generating forecasts of supply requirements for the Alkermes 8700 Product and Placebo pursuant to the Initial Development Plan and delivering such forecasts to the ST;
(iv) exchanging information and facilitating cooperation and coordination between the Parties as they exercise their respective rights and meet their respective obligations under the Initial Development Plan;
(v) providing status updates to the JSC regarding Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. pursuant to the Initial Development Plan, including progress towards achieving key milestone events and Development Cost expenditures; and
(vi) performing such other functions as appropriate to further the purposes of this Agreement as determined by mutual agreement of the Parties. In addition, the DT may designate subteams as appropriate to facilitate coordination and cooperation in key areas. The development plan for the Alkermes 8700 Product in the Initial Indication in the U.S. and the accompanying budget are attached hereto as Exhibit C (as amended from time to time in accordance with this Agreement, the “Initial Development Plan”). This Initial Development Plan shall be deemed to have been reviewed and approved by the JSC. The Initial Development Plan attached hereto as Exhibit C covers Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. through the filing of the Alkermes 8700 Product 505(b)(2) NDA (including the regulatory strategy for obtaining, supporting or maintaining Regulatory Approval of the Alkermes 8700 Product in the Initial Indication in the U.S.). The Initial Development Plan may be amended upon the written agreement of each Party to include additional Development activities for the Alkermes 8700 Product in the Initial Indication in the U.S. but, notwithstanding anything to the contrary set forth under this Agreement, will not include any Post-Marketing Commitments or Post-Marketing Clinical Trials for the Alkermes 8700 Product. The...
Development Team Responsibilities. (A) As part of its responsibilities, the Development Team shall 28 29 (1) ***;