Phase 3 Costs. (i) If Miragen and Servier are required to share the Phase 3 Costs as set forth in Section 5.4(b)(i), then within [*] days after the end of each calendar quarter during which the Parties are conducting the Phase 3 Clinical Trials of the Licensed Products, each Party shall submit to the other Party a reasonably detailed report setting forth all Phase 3 Costs incurred by such Party in such calendar quarter. Within [*] days after the receipt of such reports, the Parties shall confer and agree on whether a reconciliation payment is due from one Party to the other, and if so, the amount of such reconciliation payment, so that the Parties share the Phase 3 Costs in accordance with Section 5.4(b)(i). The Party required to pay such reconciliation payment shall pay to the other Party such payment within [*] days after the end of such [*] day period. (ii) If Servier is responsible for one hundred percent (100%) of the Phase 3 Costs as set forth in Section 5.4(b)(ii), then within [*] days after the end of each calendar quarter which the Parties are conducting the Phase 3 Clinical Trials of the Licensed Products, Miragen shall submit to Servier a reasonably detailed invoice setting forth all the Phase 3 Costs incurred by Miragen in such calendar quarter. Servier shall pay to Miragen the amount invoiced within [*] days after the receipt of the invoice. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. (iii) If Miragen is required to reimburse Servier for [*] of the Phase 3 Costs as set forth in Section 5.4(b)(ii)(1) or 5.4(b)(ii)(2), then within [*] days after the end of each calendar quarter which the Parties are conducting the Phase 3 Clinical Trials of the Licensed Products, the date upon which Miragen enters into a U.S. Partner Agreement, and/or the date upon which Miragen files MAA for the Licensed Product in the U.S., as applicable, Servier shall submit to Miragen a reasonably detailed invoice setting forth [*] of the Phase 3 Costs incurred by Servier in such calendar quarter or before such date, as applicable. Miragen shall pay to Servier the amount invoiced within [*] days after the receipt of the invoice.
Appears in 2 contracts
Samples: License and Collaboration Agreement (Signal Genetics, Inc.), License and Collaboration Agreement (Signal Genetics, Inc.)
Phase 3 Costs. The Development Plan Costs that are incurred by the Parties in preparing, conducting and analyzing the Phase 3 Clinical Trials and that are not Companion Diagnostic Development Costs (the “Phase 3 Costs”) of each Licensed Product shall be allocated between the Parties as follows:
(i) If (1) Miragen enters into an agreement with a Third Party and grants such Third Party the right to Develop and/or Commercialize a Licensed Product in the Field in the U.S. (a “U.S. Partner Agreement”) at least 180 days before the Initiation of the first Phase 3 Clinical Trial of such Licensed Product, or (2) Miragen notifies Servier are required at least 180 days before the Initiation of the first Phase 3 Clinical Trial that it wishes to share the costs of such Phase 3 Clinical Trial and all subsequent Phase 3 Clinical Trials for such Licensed Product then, Servier and Miragen shall [*] be responsible for [*] of all Phase 3 Costs of such Licensed Product as set forth in Section 5.4(b)(i9.3(b)(i), then within [*] days after the end of each calendar quarter during which the Parties are conducting the Phase 3 Clinical Trials of the Licensed Products, each Party shall submit to the other Party a reasonably detailed report setting forth all Phase 3 Costs incurred by such Party in such calendar quarter. Within [*] days after the receipt of such reports, the Parties shall confer and agree on whether a reconciliation payment is due from one Party to the other, and if so, the amount of such reconciliation payment, so that the Parties share the Phase 3 Costs in accordance with Section 5.4(b)(i). The Party required to pay such reconciliation payment shall pay to the other Party such payment within [*] days after the end of such [*] day period.
(ii) If Servier is responsible for one hundred percent (100%) of the Phase 3 Costs as set forth in Section 5.4(b)(ii), then within [*] days after the end of each calendar quarter which the Parties are conducting the Phase 3 Clinical Trials of the Licensed Products, Miragen shall submit to Servier a reasonably detailed invoice setting forth all the Phase 3 Costs incurred by Miragen in such calendar quarter. Servier shall pay to Miragen the amount invoiced within [*] days after the receipt of the invoice. [*] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended.
(iiiii) If Miragen is required does not enter into a U.S. Partner Agreement at least 180 days before the Initiation of the first Phase 3 Clinical Trial of a Licensed Product, then Servier shall be responsible for [*] of such Phase 3 Costs of such Licensed Products and shall reimburse such Phase 3 Costs incurred by Miragen pursuant to Section 9.3(b)(ii). Miragen shall reimburse Servier for part of such Phase 3 Costs as follows, pursuant to Section 9.3(b)(iii):
(1) If Miragen subsequently enters into a U.S. Partner Agreement before the completion of any Phase 3 Clinical Trial of such Licensed Product, then Miragen shall promptly reimburse Servier for [*] of all Phase 3 Costs of such Licensed Product incurred by Servier prior to Miragen’s entry into such U.S. Partner Agreement, and Miragen shall continue to reimburse Servier for [*] of the Phase 3 Costs as set forth in Section 5.4(b)(ii)(1) or 5.4(b)(ii)(2), then within [*] days after the end of each calendar quarter which the Parties are conducting the such Licensed Product incurred by Servier thereafter with respect to any Phase 3 Clinical Trials of the Licensed Products, the date upon which Trial; and
(2) If Miragen enters does not enter into a U.S. Partner AgreementAgreement before the completion of any Phase 3 Clinical Trial of such Licensed Product, and/or the date upon which then Miragen files MAA shall reimburse Servier for the Licensed Product in the U.S., as applicable, Servier shall submit to Miragen a reasonably detailed invoice setting forth [*] of the Phase 3 Costs of such Licensed Product incurred by Servier with respect to such Phase 3 Clinical Trial upon Miragen’s filing of MAA for such Licensed Product in the U.S., which MAA includes data from such calendar quarter or before such datePhase 3 Clinical Trial. For the purpose of this Section 5.4(b), as applicable. Miragen shall pay to Servier the amount invoiced within [*] days after means the receipt of the invoice[*].
Appears in 2 contracts
Samples: License and Collaboration Agreement (Signal Genetics, Inc.), License and Collaboration Agreement (Signal Genetics, Inc.)