Initial NDA definition
Examples of Initial NDA in a sentence
The Development Costs of any such additional Clinical Trial required in connection with the Initial NDA pre-NDA Approval Date shall be paid by the Licensor, provided that a sum equal to the first [*] dollars ($[*]) and [*] per cent ([*]%) of any Development Costs exceeding [*] dollars ($[*]) shall be reimbursed by the Licensee, by being paid in addition to the milestone payable under Clause 10.10, upon payment of such milestone.
For the avoidance of doubt, during the Manufacturing Period all decisions relating to the Specification and methods of manufacturing shall be made solely by Licensor provided that Licensor shall give Licensee reasonable notice in writing of any changes prior to effecting them and provided that such changed Specification is still in accordance with the Initial NDA and any subsequent NDA.
Licensee shall be responsible for the preparation, submission and prosecution of all necessary Regulatory Authority filings and applications required to obtain all label extensions or label changes to the Initial NDA, to obtain any subsequent NDA for the Product and to Commercialise Product in the Territory.
Forma shall be responsible for paying all costs, including the Out-of-Pocket Costs incurred by Forma that are associated with obtaining Regulatory Approval of the Licensed Product with respect to the Initial NDA in accordance with the Transition Plan.
Without limiting the generality of the foregoing, Company shall use Commercially Reasonable Efforts to achieve the First Commercial Sale in the U.S. of the Licensed Product in the Initial Indication within [***] days following Regulatory Approval of the Initial NDA.
As set forth in Section 24(xiii), this section supersedes the Initial NDA (as such term is defined in Section 24(xiii)).
Prior to assignment of the Approved NDA, subject to the terms and conditions of this Agreement, including this Section 2.8 and Section 2.9, Forma shall be responsible for all regulatory matters relating to the Initial NDA, including overseeing, monitoring and coordinating all regulatory actions, communications and filings with, and submissions to, the FDA with respect to the Initial NDA (the “Forma Regulatory Activities”) as necessary for Regulatory Approval.
BLP further agrees to continue to provide Pharmos with BLP Technical Documentation as Pharmos may reasonably deem necessary or appropriate solely in order for Pharmos to obtain and thereafter maintain FDA approval of the Initial NDA and any subsequent NDA as Pharmos may from time to time reasonably request during the Term.
Company may terminate this Agreement in its entirety upon delivery of [***] days’ prior written notice to Forma in the event that the Initial NDA is not approved by the FDA on or before [***].
Promptly following the Effective Date, the Parties shall establish a Joint Steering Committee (“JSC”) to review, discuss, oversee the preparation, filing and FDA review of the Initial NDA and any other NDA submitted by or on behalf of Forma for the Licensed Product and implement the Transition Plan.