Common use of New Development Collaboration Proposals Clause in Contracts

New Development Collaboration Proposals. If either Party proposes to conduct new Development activities in connection with the Development of a Licensed Product not included in the then approved Global Development Plan, including any proposal to collaborate to *** (such proposal, a “Development Collaboration Proposal”), such Party shall submit the Development Collaboration Proposal to the other Party through the JRDC. Every Development Collaboration Proposal shall include a proposal to collaborate with the other Party for such Development activities so that, subject to the terms of this Agreement, with respect to the Development activities underlying the Development Collaboration Proposal, Servier shall be able to Develop Licensed Products for Commercialization in the Field in the Servier Territory and MacroGenics shall be able to Develop Licensed Products for Commercialization in the Field in the MacroGenics Territory. (i) In the event the other Party approves a Development Collaboration Proposal and the Parties agree to collaborate to conduct the Development activities underlying the Development Collaboration Proposal with respect to Licensed Products, each Party shall use Commercially Reasonable Efforts to perform the activities allocated to it under the approved Development Collaboration Proposal, and the Parties shall share in the payment of Development Costs incurred in connection with such activities in accordance with Section 5.5.1(a). (ii) In the event the other Party declines to participate in and share the funding of such activity (the “Buy-In Party”), the submitting Party may proceed with the activities described in such Development Collaboration Proposal at its sole expense unless the other Party reasonably objects to the conduct of such activity as reasonably likely to result in a safety or public health issue that will have a material adverse effect in the Development or Commercialization of Program Antibodies and Licensed Product in its territory. Any disputes regarding whether an activity is reasonably likely to result in a safety or public health issue that will have a material adverse impact on the Development and/or Commercialization of Program Antibodies and Licensed Products in a Party’s territory shall be referred to the JRDC for a determination and resolved in accordance with Section 2.9; provided that neither Party shall have the right to exercise its final decision making authority pursuant to Section 2.9.3 with respect to such issue. (iii) Once during each Calendar Quarter following the commencement of, and until the completion of, the activities described in the Development Collaboration Proposal, the Buy-In Party may request that the Party conducting such Development activity provide a summary of the current status of such Development activity, the Development Costs incurred to date, any significant milestones achieved and any topline initial results of such Development activity. (iv) The Buy-In Party may obtain access to and use of the Excluded Data in accordance with the procedure described in this paragraph; provided that the Buy-In Party shall be provided access to Safety Data, at no cost, in accordance with the SDEA Agreement. At any time following the commencement of the activities described in the Development Collaboration Proposal, the Buy-In Party shall provide the other Party with written notice of its election to buy-in to such Development, and promptly thereafter the other Party shall provide the Buy-In Party with an invoice for *** of the cumulative Development Costs as well as the costs of clinical supply of the Program Antibody and/or Licensed Product used in connection with such Development incurred by a Party in the generation of such data as of the date of the Buy-In Party’s written request (the “Buy-in Amount”), which invoice the Buy-In Party shall pay within *** after receipt. Each Party shall thereafter share, in accordance with the allocation of costs set forth in Section 5.5.1(a), in the Development Costs incurred after the date of the Buy-In Party’s written request in connection with such Development activities under such Development Collaboration Proposal and the Global Development Plan shall be amended to include such Development activities.

Appears in 2 contracts

Samples: Option for a License Agreement (Macrogenics Inc), Option for a License Agreement (Macrogenics Inc)

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New Development Collaboration Proposals. If either Party proposes to conduct new Development activities in connection with the Development of a Licensed Product not included in the then approved Global Development PlanPlan of the Licensed Program for such Licensed Product, including any proposal to collaborate to *** (such proposal, a “Development Collaboration Proposal”), such Party shall submit the Development Collaboration Proposal to the other Party through the JRDC. Every Development Collaboration Proposal shall include a proposal to collaborate with the other Party for such Development activities so that, subject to the terms of this Agreement, with respect to the Development activities underlying the Development Collaboration Proposal, Servier shall be able to Develop Licensed Products for Commercialization in the Field in the Servier Territory and MacroGenics shall be able to Develop Licensed Products for Commercialization in the Field in the MacroGenics Territory. (i) In the event the other Party approves a Development Collaboration Proposal and the Parties agree to collaborate to conduct the Development activities underlying the Development Collaboration Proposal with respect to Licensed Products, (A) the Global Development Plan shall be amended to include such Development Collaboration Proposal and (B) each Party shall use Commercially Reasonable Efforts to perform the activities allocated to it under the approved Development Collaboration Proposal, and the Parties shall share in the payment of Development Costs incurred in connection with such activities in accordance with Section 5.5.1(a). (ii) In the event the other Party declines to participate in and share the funding of such activity (the “Buy-In Party”), the submitting Party may proceed with the activities described in such Development Collaboration Proposal at its sole expense unless the other Party reasonably objects to the conduct of such activity as reasonably likely to result in a safety or public health issue that will have a material adverse effect in the Development or Commercialization of Program Antibodies DARTs and Licensed Product in its territory. Any disputes regarding whether an activity is reasonably likely to result in a safety or public health issue that will have a material adverse impact on the Development and/or Commercialization of Program Antibodies DARTs and Licensed Products in a Party’s territory shall be referred to the JRDC for a determination and resolved in accordance with Section 2.9; provided that neither Party shall have the right to exercise its final decision making authority pursuant to Section 2.9.3 with respect to such issue. (iii) Once during each Calendar Quarter following the commencement of, and until the completion of, the activities described in the Development Collaboration Proposal, the Buy-In Party may request that the Party conducting such Development activity provide a summary of the current status of such Development activity, the Development Costs incurred to date, any significant milestones achieved and any topline initial results of such Development activity. (iv) The Buy-In Party may obtain access to and use of the Excluded Data in accordance with the procedure described in this paragraph; provided that the Buy-In Party shall be provided access to Safety Data, at no cost, in accordance with the SDEA Agreement. At any time following the commencement of the activities described in the Development Collaboration Proposal, the Buy-In Party shall provide the other Party with written notice of its election to buy-in to such Development, and promptly thereafter the other Party shall provide the Buy-In Party with an invoice for *** of the cumulative Development Costs as well as the costs of clinical supply of the Program Antibody DART and/or Licensed Product used in connection with such Development incurred by a Party in the generation of such data as of the date of the Buy-In Party’s written request (the “Buy-in Amount”), which invoice the Buy-In Party shall pay within *** after receipt. Each Party shall thereafter share, in accordance with the allocation of costs set forth in Section 5.5.1(a), in the Development Costs incurred after the date of the Buy-In Party’s written request in connection with such Development activities under such Development Collaboration Proposal and the Global Development Plan shall be amended to include such Development activities.

Appears in 2 contracts

Samples: Option for a License Agreement (Macrogenics Inc), Option for a License Agreement (Macrogenics Inc)

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New Development Collaboration Proposals. If either Party proposes to conduct new Development activities in connection with the Development of a Licensed Product not included in the then approved Global Development PlanPlan of the Licensed Program for such Licensed Product, including any proposal to collaborate to *** (such proposal, a “Development Collaboration Proposal”), such Party shall submit the Development Collaboration Proposal to the *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. other Party through the JRDC. Every Development Collaboration Proposal shall include a proposal to collaborate with the other Party for such Development activities so that, subject to the terms of this Agreement, with respect to the Development activities underlying the Development Collaboration Proposal, Servier shall be able to Develop Licensed Products for Commercialization in the Field in the Servier Territory and MacroGenics shall be able to Develop Licensed Products for Commercialization in the Field in the MacroGenics Territory. (i) In the event the other Party approves a Development Collaboration Proposal and the Parties agree to collaborate to conduct the Development activities underlying the Development Collaboration Proposal with respect to Licensed Products, (A) the Global Development Plan shall be amended to include such Development Collaboration Proposal and (B) each Party shall use Commercially Reasonable Efforts to perform the activities allocated to it under the approved Development Collaboration Proposal, and the Parties shall share in the payment of Development Costs incurred in connection with such activities in accordance with Section 5.5.1(a). (ii) In the event the other Party declines to participate in and share the funding of such activity (the “Buy-In Party”), the submitting Party may proceed with the activities described in such Development Collaboration Proposal at its sole expense unless the other Party reasonably objects to the conduct of such activity as reasonably likely to result in a safety or public health issue that will have a material adverse effect in the Development or Commercialization of Program Antibodies DARTs and Licensed Product in its territory. Any disputes regarding whether an activity is reasonably likely to result in a safety or public health issue that will have a material adverse impact on the Development and/or Commercialization of Program Antibodies DARTs and Licensed Products in a Party’s territory shall be referred to the JRDC for a determination and resolved in accordance with Section 2.9; provided that neither Party shall have the right to exercise its final decision making authority pursuant to Section 2.9.3 with respect to such issue. (iii) Once during each Calendar Quarter following the commencement of, and until the completion of, the activities described in the Development Collaboration Proposal, the Buy-In Party may request that the Party conducting such Development activity provide a summary of the current status of such Development activity, the Development Costs incurred to date, any significant milestones achieved and any topline initial results of such Development activity. (iv) The Buy-In Party may obtain access to and use of the Excluded Data in accordance with the procedure described in this paragraph; provided that the Buy-In Party shall be provided access to Safety Data, at no cost, in accordance with the SDEA Agreement. At any time following the commencement of the activities described in the Development Collaboration Proposal, the Buy-In Party shall provide the other Party with written notice of its election to buy-in to such Development, and promptly thereafter the other Party shall provide the Buy-In Party with an invoice for *** of the cumulative Development Costs as well as the costs of clinical supply of the Program Antibody DART and/or Licensed Product used in connection with such *** = Portions of this exhibit have been omitted pursuant to a request for confidential treatment. An unredacted version of this exhibit has been filed separately with the Commission. Development incurred by a Party in the generation of such data as of the date of the Buy-In Party’s written request (the “Buy-in Amount”), which invoice the Buy-In Party shall pay within *** after receipt. Each Party shall thereafter share, in accordance with the allocation of costs set forth in Section 5.5.1(a), in the Development Costs incurred after the date of the Buy-In Party’s written request in connection with such Development activities under such Development Collaboration Proposal and the Global Development Plan shall be amended to include such Development activities.

Appears in 1 contract

Samples: Option for a License Agreement

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