Specific Milestones. Without limiting Section 4.1, Licensee will meet the following milestones: (a) Closing of $**** in financing **** from Effective Date (b) Milestones will be set forth in the initial Development Plan for the hemophilia A indication described in Section 1.11(a) and agreed upon by the Parties **** (c) Milestones will be set forth in the initial Development Plan for the hemophilia B indication described in Section 1.11(b) and agreed upon by the Parties **** (d) Filing of an investigational new drug application with the FDA for the proposed initial clinical trial of a Licensed Product targeting the first additional specific disease indication (as set forth in Section 1.11(c)) **** from the date on which the specific disease indication is added to the Field pursuant to Section 2.4 (e) Filing of an investigational new drug application with the FDA for the proposed initial clinical trial of a Licensed Product targeting the second additional specific disease indication (as set forth in Section 1.11(c)) **** from the date on which the specific disease indication is added to the Field pursuant to Section 2.4 Licensee will provide Licensor written notice within **** of the accomplishment of each of the foregoing milestones. For the avoidance of doubt, a breach of the milestone in (a) above will be deemed a breach with respect to all disease indications within the Field. If Licensee fails to meet a milestone for a particular disease indication within the Field, the date of the milestone (****) may, at Licensee’s option, be extended for a period of **** from the original deadline date upon a payment to Licensor of **** within **** of the original deadline date; provided that Licensee will be entitled only to **** for each disease indication within the Field, and each **** ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. will require a separate payment of ****. The Parties agree that the failure of Licensee to achieve a specific milestone contained in this Section 4.2 or in a Development Plan described in Section 4.3 for reasons beyond Licensee’s reasonable control **** will not be considered a material breach hereunder; ****.
Appears in 3 contracts
Samples: License Agreement (REGENXBIO Inc.), License Agreement (REGENXBIO Inc.), License Agreement (REGENXBIO Inc.)
Specific Milestones. Without limiting Section 4.1, Licensee will meet the following milestones:
(a) Closing of $[…**** …] in financing […**** …] from Effective Date
(b) Milestones will be set forth in the initial Development Plan for the hemophilia A indication described in Section 1.11(a) and agreed upon by the Parties […****…]
(c) Milestones will be set forth in the initial Development Plan for the hemophilia B indication described in Section 1.11(b) and agreed upon by the Parties […****…]
(d) Filing of an investigational new drug application with the FDA for the proposed initial clinical trial of a Licensed Product targeting the first additional specific disease indication (as set forth in Section 1.11(c)) […**** …] from the date on which the specific disease indication is added to the Field pursuant to Section 2.4
(e) Filing of an investigational new drug application with the FDA for the proposed initial clinical trial of a Licensed Product targeting the second additional specific disease indication (as set forth in Section 1.11(c)) […**** …] from the date on which the specific disease indication is added to the Field pursuant to Section 2.4 Licensee will provide Licensor written notice within […**** …] of the accomplishment of each of the foregoing milestones. For the avoidance of doubt, a breach of the milestone in (a) above will be deemed a breach with respect to all disease indications within the Field. If Licensee fails to meet a milestone for a particular disease indication within the Field, the date of the milestone ([…****…]) may, at Licensee’s option, be extended for a period of […**** …] from the original deadline date upon a payment to Licensor of […**** …] within […**** …] of the original deadline date; provided that Licensee will be entitled only to […**** …] for each disease indication within the Field, and each […**** ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. …] will require a separate payment of […****…]. The Parties agree that the failure of Licensee to achieve a specific milestone contained in this Section 4.2 or in a Development Plan described in Section 4.3 for reasons beyond Licensee’s reasonable control […**** …] will not be considered a material breach hereunder; […****…].
Appears in 2 contracts
Samples: License Agreement (Dimension Therapeutics, Inc.), License Agreement (Dimension Therapeutics, Inc.)
Specific Milestones. Without limiting Section 4.1, Licensee will meet the following milestones:
(a) Closing of $[…**** …] in financing […**** …] from Effective Date
(b) Milestones will be set forth in the initial Development Plan for the hemophilia A indication described in Section 1.11(a) and agreed upon by the Parties […****…]
(c) Milestones will be set forth in the initial Development Plan for the hemophilia B indication described in Section 1.11(b) and agreed upon by the Parties […****…]
(d) Filing of an investigational new drug application with the FDA for the proposed initial clinical trial of a Licensed Product targeting the first additional specific disease indication (as set forth in Section 1.11(c)) […**** …] from the date on which the specific disease indication is added to the Field pursuant to Section 2.4
(e) Filing of an investigational new drug application with the FDA for the proposed initial clinical trial of a Licensed Product targeting the second additional specific disease indication (as set forth in Section 1.11(c)) […**** …] from the date on which the specific disease indication is added to the Field pursuant to Section 2.4 Licensee will provide Licensor written notice within […**** …] of the accomplishment of each of the foregoing milestones. For the avoidance of doubt, a breach of the milestone in (a) above will be deemed a breach with respect to all disease indications within the Field. If Licensee fails to meet a milestone for a particular disease indication within the Field, the date of the milestone ([…****…]) may, at Licensee’s option, be extended for a period of […**** …] from the original deadline date upon a payment to Licensor of […**** …] within […**** …] of the original deadline date; provided that Licensee will be entitled only to […**** …] for each *** Confidential Treatment Requested *** disease indication within the Field, and each […**** ****CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. …] will require a separate payment of […****…]. The Parties agree that the failure of Licensee to achieve a specific milestone contained in this Section 4.2 or in a Development Plan described in Section 4.3 for reasons beyond Licensee’s reasonable control […**** …] will not be considered a material breach hereunder; […****…].
Appears in 1 contract