Responsibilities of the Joint Development Team Clause Samples

Responsibilities of the Joint Development Team. The JDT shall be responsible for: (a) Preparing for approval by the JSC and thereafter implementing the annual updates to the Joint Development Plan and Joint Budget. (b) Developing an overall strategy for the Development of the Collaboration Product(s) for review and approval by the JSC. (c) Formulating any amendments to the Joint Development Plan (including allocation of Development activities between the Parties) and the Joint Budget for review and approval by the JSC. (d) Making recommendations to the JSC for further Development of the Collaboration Product(s), including Development for new indications that are not in the then current Joint Development Plan. (e) Making forecasts of clinical supplies requirements for Development of the Collaboration Product and reviewing the supply of Collaboration Product. (f) Developing a strategy for approval by the JSC for assignment of sponsorship of clinical studies and related regulatory filings from one Party to the other Party or to a Third Party following an Opt-In Notice, Opt-Out Notice or otherwise in each country where clinical studies may be planned. Such strategy to include a policies and guidelines designed to enable an assignment, including in terms of agreements (such as but not limited to agreements with clinical research organizations, clinical trial agreements, pharmacy agreements), insurance and regulatory documents, prior to initiation of such clinical studies. In addition, developing a similar strategy for approval by the JSC for winding down activities for Dormant Products. (g) Exchanging information regarding the conduct of ongoing Clinical Trials and the Development of the Collaboration Product(s) and the exercise and meeting of the Parties’ respective rights and obligations under the Joint Development Plan and this Agreement. (h) Providing status updates to the JSC regarding Development activities. (i) Overseeing and monitoring the selection of any contract manufacturers and negotiation of agreements with same. (j) Functioning as a forum under which SGI and Genmab would exchange information to enable the Parties to manage the day-to-day aspects of the manufacturing and supply chain for the Collaboration Product, defending pre-approval inspections and establishing production capability at either contract manufacturers’ or the Parties’ sites. (k) Discussing and facilitating technology transfer to establish process at contract manufacturers’ sites, if necessary. (l) Discussing and facilitating p...
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