Servier Territory Exclusive Development Activities. Except as provided in Section 5.5 and for Development activities conducted by a Party at its own expense pursuant to Section 5.4.2(b)(ii), Servier shall be responsible for *** of all Development Costs (whether incurred by Servier or MacroGenics (if the activities and their cost are agreed to in advance in writing by Servier) or their respective Affiliates) set forth in the applicable Development Budget with respect to any Development activities that are conducted for the primary purpose of obtaining or maintaining Regulatory Approval for Licensed Products in the Field in any country or other regulatory jurisdiction in the Servier Territory. On a Licensed Program-by-Licensed Program basis, Servier shall disclose to MacroGenics a summary of efficacy results and detailed safety information Controlled by Servier and generated in the course of such Development activities for each Licensed Program within *** after the completion of such activities, subject to the pharmacovigilence provision under Section 6.5. MacroGenics may obtain access to and use Servier’s data (other than Safety Data which shall in all cases be exchanged, at no cost, in accordance with the SDEA) obtained in such exclusive development activities if MacroGenics provides Servier with written notice of its election to buy-in such Development, and promptly thereafter Servier shall provide MacroGenics with an invoice for *** of the cumulative Development Costs as well as the costs *** in connection with such Development incurred by Servier in the generation of such data as of the date of MacroGenics written request, which invoice MacroGenics shall pay within *** after receipt.
Appears in 3 contracts
Samples: Option for a License Agreement, Option for a License Agreement (Macrogenics Inc), Option for a License Agreement (Macrogenics Inc)
Servier Territory Exclusive Development Activities. Except as provided in Section 5.5 and for Development activities conducted by a Party at its own expense pursuant to Section 5.4.2(b)(ii), Servier shall be responsible for *** of all Development Costs (whether incurred by Servier or MacroGenics (if the activities and their cost are agreed to in advance in writing by Servier) or their respective Affiliates) set forth in the applicable Development Budget with respect to any Development activities that are conducted for the primary purpose of obtaining or maintaining Regulatory Approval for Licensed Products in the Field in any country or other regulatory jurisdiction in the Servier Territory. On a Licensed Program-by-Licensed Program basis, Servier shall disclose to MacroGenics a summary of efficacy results and detailed safety information Controlled by Servier and generated in the course of such Development activities for each Licensed Program within *** after the completion of such activities, subject to the pharmacovigilence provision under Section 6.5. MacroGenics may obtain access to and use Servier’s data (other than Safety Data which shall in all cases be exchanged, at no cost, in accordance with the SDEA) obtained in such exclusive development activities if MacroGenics provides Servier with written notice of its election to buy-in such Development, and promptly thereafter Servier shall provide MacroGenics with an invoice for *** of the cumulative Development Costs as well as the costs *** in connection with such Development incurred by Servier in the generation of such data as of the date of MacroGenics written request, which invoice MacroGenics shall pay within *** after receipt.
Appears in 2 contracts
Samples: Option for a License Agreement (Macrogenics Inc), Option for a License Agreement (Macrogenics Inc)