Common use of Formation and Role Clause in Contracts

Formation and Role. Within [***] after the Effective Date, the Parties shall establish a joint development committee (the “JDC”) that will monitor the Development of Product in the Field in the Licensed Territory. The role of the JDC is: (i) to monitor the Development of Product in the Field in the Licensed Territory, and to discuss the development of Product in the Field in the Licensor Territory; (ii) to prepare the Development Plan (including the Regulatory Plan) and any amendments to the Development Plan, including the budget and anticipated timeline for performing each Development activity and the detailed design including the key elements of the protocol of each Clinical Study or other study included or proposed to be included in the Development Plan, for review, discussion and approval by the JSC; (iii) to agree on the plan (1) to determine the regulatory requirements for approval in the licensed indication(s) if these requirements are not already clearly stated in written documents from the applicable Regulatory Authority and (2) to address such requirements; (iv) to review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to Product in the Field, if any; (v) to discuss Development activities in the Field as between the Licensed Territory and the Licensor Territory; (vi) to facilitate the flow of Information between the Parties with respect to the development of, and obtaining Drug Approval for, Product in the Field; and (vii) to perform such other functions as may be appropriate to further the purposes of this Agreement with respect to the Development of Product in the Field in the Licensed Territory, as directed by the JSC.

Formation and Role. Within [***[ * ] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or “JDC”) that will monitor be responsible for overseeing the Development of the Product in the Field in the Licensed TerritoryField. The role of the JDC isshall be: (i) to monitor oversee the Development of the Product in the Field in the Licensed Territory, and to discuss the development of Product in the Field in the Licensor TerritoryField; (ii) to prepare the Development Plan (including the Regulatory Plan) and any amendments to the Development Plan, including the budget and anticipated timeline for performing each Development activity and the detailed design including the key elements of the protocol of each Clinical Study clinical trial or other study included or proposed to be included in the Development Plan, for review, discussion review and approval by the JSC, the first amendment of which shall be to add a Regulatory Plan created by the JDC; (iii) to agree on the plan (1) to determine the regulatory requirements for approval Drug Approval in the licensed indication(s) if these requirements are not already clearly stated in written documents from the applicable Regulatory Authority and (2) to address such requirementsLicensed Territory; (iv) to establish general guidelines for Investigator-Sponsored Studies with respect to a Product in the Field which, if complied with by a particular ISS, will allow a Party to authorize or facilitate such ISS on prior notice to the JDC but without the need for obtaining the other Party’s approval; (v) to review any disputes between the Parties regarding a potential Material Impact of an ISS that does not comply with the general guidelines established by the JDC; (vi) to review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to Product Products in the Field, if any; (vvii) to discuss Development activities in the Field as between the Licensed Territory and the Licensor Allos Territory; (viviii) to facilitate the flow of Information between the Parties with respect to the development Development of, and obtaining Drug Approval for, Product Products in the Field; and (viiix) to perform such other functions as may be appropriate to further the purposes of this Agreement Agreement, with respect to the Development of the Product in the Field in the Licensed TerritoryField, as directed by the JSC.

Formation and Role. Within [***] after the Effective Date, the Parties shall establish a joint development committee (the “"Joint Development Committee" or "JDC”") that will monitor be responsible for overseeing the Development of the Product in the Field in the Licensed TerritoryField. The role of the JDC isshall be: (i) to monitor oversee the Development of the Product in the Field in the Licensed Territory, and to discuss the development of Product in the Field in the Licensor TerritoryField; (ii) to prepare the Development Plan (including the Regulatory Plan) and any amendments to the Development Plan, including the budget and anticipated timeline for performing each Development activity and the detailed design including the key elements of the protocol of each Clinical Study clinical trial or other study included or proposed to be included in the Development Plan, for review, discussion review and approval by the JSC, the first amendment of which shall be to add a Regulatory Plan created by the JDC; (iii) to agree on the plan (1) to determine the regulatory requirements for approval Drug Approval in the licensed indication(s) if these requirements are not already clearly stated in written documents from the applicable Regulatory Authority and (2) to address such requirementsLicensed Territory; (iv) to establish general guidelines for Investigator-Sponsored Studies with respect to a Product in the Field which, if complied with by a particular ISS, will allow a Party to authorize or facilitate such ISS on prior notice to the JDC but without the need for obtaining the other Party's approval; (v) to review any disputes between the Parties regarding a potential Material Impact of an ISS that does not comply with the general guidelines established by the JDC; (vi) to review, discuss and coordinate the Parties’ ' scientific presentation and publication strategy relating to Product Products in the Field, if any; (vvii) to discuss Development activities in the Field as between the Licensed Territory and the Licensor Allos Territory; (viviii) to facilitate the flow of Information between the Parties with respect to the development Development of, and obtaining Drug Approval for, Product Products in the Field; and (viiix) to perform such other functions as may be appropriate to further the purposes of this Agreement Agreement, with respect to the Development of the Product in the Field in the Licensed TerritoryField, as directed by the JSC.